What do you think the most important thing a potential clinical trial participant should know about clinical research when they are deciding whether to participate? What does clinical research mean to you?

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What do you think the most important thing a potential clinical trial participant should know about clinical research when they are deciding whether to participate? What does clinical research mean to you?

When talking with a patient, we should ALWAYS keep in mind the three principles of the Belmont Report. A patient must understand that they can discontinue study participation without negative repercussions from the principal investigator, or taken out if it becomes unsafe for the patient; what kind of patients and populations can and cannot participate; and what is the benefit if any. This simplistic approach if done correctly, by a study staff member should cover almost everything a patient needs to know. Patients should also know what responsibilities and commitments they have to the study.  We as the research staff must educate with every tool available what this commitment means, and what we can do to support each study subject to ensure compliance.  Inculcating this responsibility to the study subject gives him/her a sense of empowerment over their health and the realization of real altruism.  I encourage the self-empowerment an extra notch my making sure they know the IRBs phone number and tell them “if you are ever unhappy with what we are doing and don’t think I’m doing my job, call the IRB for the study”. Patients always smile and I can tell it makes them feel good knowing that we are being so honest with them. 

I am a strong believer and advocate that clinical research is the complement to the current medical practice. Paring a patient with the most suitable study is so important to keeping a high study subject benefit to low risk ratio; that is what makes the complement of research shine.

Clinical Research is the future of Medicine and it needs three main components, 1-study sponsors 2- Investigators 3- Patients/family member; without all three there is no future in medicine, we must keep open and transparent lines of communication among them all; that is what clinical research means to me.  

Fabian Sandoval
CEO & Medical Director, ECRI

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Fabian Sandoval
CEO & Medical Director, ECRI

Dr. Fabian Sandoval, CEO & Medical Director, has over 18 years of bench to bedside research experience. His diversified research career has been in academia, healthcare systems and the public sector. He received his Bachelors of Science in molecular and cellular biology from Marymount University, and his Doctorate of Medicine (Medical Surgeon Degree) from the Autonomous University of Guadalajara, School of Medicine.

Before opening the doors to Emerson Clinical Research Institute (ECRI) Dr. Sandoval’s research activities have included bench research at the National Institutes of Neurological Disorders and Stroke (NINDS) where he focused his work on Early Onset Alzheimer’s Disease, and Cretzfelt-Jakob Disease. At the NIHs’ Clinical Center conducting research in the outpatient Oncology unit, followed by his successful support of an NIH RO1 grant on preventing epilepsy in post-traumatic brain injury patients in adults and children, simultaneously run at the Washington Hospital Center, and Children’s National Medical Center.

Dr. Sandoval served as the Supervisory Research Integrity & Compliance Officer in the Army Human Research Protections Office in the Office of the Army Surgeon General. Responsibilities included establishment, and oversight of Human Research Protection Programs across Army commands. His input has been instrumental in the review, development, and selection of protocols, in addition to education and training for resident and hospital faculty.

Outside of ECRI

In addition to his commitment to improve the representation of minorities in clinical research, Dr. Sandoval holds the following esteemed positions in the following research community areas:

-Leadership Council for Society for Clinical Research Sites (SCRS)

-Public Responsibility in Medicine and Research (PRIM&R)

-Scientific reviewer for Poster Abstract Sub-Committee.

-MedStar Health Research Institute

-Member, Conflict of Interest Committee.

-Journal of Healthcare, Science, and the Humanities

-Scientific reviewer.

-The Journal of Research Administration

-Scientific reviewer.

 

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What do you think the most important thing a potential clinical trial participant should know about clinical research when they are deciding whether to participate? What does clinical research mean to you?

It takes years for even the most promising experimental drugs to transition through laboratory development, clinical trials, and FDA evaluation in order to reach patients. FDA, collaborating with advocacy organizations and industry, has implemented numerous measures to accelerate drug development and evaluation. This first occurred through the Prescription Drug User Fee Act, which increased FDA resources and has been renewed five times since 1992, and progressively since then a host of expedited approval mechanisms has ensured that FDA drug evaluation reflects the current state of drug development science.   These include Accelerated Approval, which allows for the approval of a drug based on a surrogate endpoint likely to predict long term benefit, and the Breakthrough Therapies designation, which provides especially promising drug candidates early in their development process with additional FDA attention, communication and flexibility. These programs have significantly improved FDA and industry efficiency, but many patients hoping for life-changing drugs still face a long wait. By participating in clinical trials, patients can accelerate access to new therapies for themselves and for other patients that may one day encounter the same disease.

Clinical trials may give patients direct access to cutting-edge drugs that have yet to reach the market. For patients facing conditions without approved treatments or for which new treatments are actively being developed, clinical trials can offer access to state of the art care. Even in cases where approved drugs exist, clinical trials might offer patients access to therapies using new mechanisms to achieve better efficacy or safety results than existing treatments. It is important to emphasize that control arms of trials are usually standard of care, and all clinical trial participants are closely supervised by clinicians and their research teams and subsequently receive very high quality care.

By participating in a clinical trial, a patient also helps to speed new drugs to patients outside of the trial. Accruing enough patients to achieve statistically significant results is a rate limiting step in many clinical studies. By participating, patients help to ensure that new drugs are tested and evaluated efficiently. Data gathered from their experiences will go on to shape treatment for future patients, allowing medical practice to progress with the rapid pace of scientific discovery.

Patients who enroll in clinical trials participate in the vanguard of medical research, helping to translate laboratory data into life-saving therapies. The most important thing for clinical trial participants to realize is that they’re not only gaining access to new treatments, but also helping to make sure that those treatments reach patients as quickly as possible.

 

 

Ryan Hohman
Managing Director, Policy & Public Affairs, Friends

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Ryan Hohman
Managing Director, Policy & Public Affairs, Friends

Ryan Hohman serves as Managing Director, Policy & Public Affairs at Friends of Cancer Research (Friends), a think tank and advocacy organization based in Washington, D.C.  Friends is our country’s leading voice in advocating for policies and proposing and promoting real solutions that will get treatments to patients in the safest and quickest way possible. Friends develops new, groundbreaking partnerships, creates a more open dialogued among both public and private sectors and tears down the barriers that stand in the way of conquering cancer. By collaborating with federal health and regulatory agencies, premier academic research centers, professional societies, members of congress and other advocacy organizations, Friends is able to accelerate innovation.

At Friends, Ryan leads the strategic development and execution of public-policy and legislative initiatives to enhance U.S. Food and Drug Administration regulatory policies and Department of Health and Human Services, and its institutes, research programs. Additionally, Ryan oversees the organizations targeted outreach, comprehensive communications strategy, federal affairs, advocacy relations, and the organizations development programs. As Managing Director of Policy & Public Affairs at Friends, Ryan has the privilege of serving on many important boards and committees of organizations who share Friends mission, including: Chair, Lung-MAP Clinical Trial Public Affairs Committee; Advisory Council Member, Enroll America; Principles Working Group, National Dialogue for Healthcare Innovation (NDHI); Strategic Advisory Committee, The Ruesch Center for the Cure of Gastrointestinal Cancers at Georgetown - Lombardi CCC; Advisory Council, Capital Breast Care Center.

During his diverse career, Ryan has experienced first-hand the vital need and incredible impact that sustained federal funding of biomedical has on physicians, researchers and scientists and the difficulties many of these communities face when engaging in and navigating the regulatory process. Before joining Friends, Ryan was Director of Corporate and Institutional Partnerships at Georgetown University’s Lombardi Comprehensive Cancer Center.  While at Georgetown, Ryan focused on the development and execution of strategic corporate and philanthropic engagement to support the center’s biomedical research and cancer treatment and education programs.  During this time, Mr. Hohman was appointed to the Board of Directors of the Cancer Research Alliance and worked to support and expand the programs of the Capital Breast Care Center, which provides comprehensive, culturally appropriate breast cancer screening services and health education to women in the Washington, DC metropolitan area.

Prior to his time at Lombardi, Ryan was an associate with a DC & Boston-based public relations firm, specializing in health and trade association media and governmental strategy. Ryan has also served in numerous political campaigns and offices, including: former Senate Majority Leader Tom Daschle’s 2004 Senate race, Senator John Edwards’ Presidential Campaign, and at the Democratic National Committee under then Chairman Terry McAuliffe.

 

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What do you think the most important thing a potential clinical trial participant should know about clinical research when they are deciding whether to participate? What does clinical research mean to you?

Participating in a clinical research study is a selfless act.  Perhaps there will be personal benefit from participating in a clinical trial, but it’s not guaranteed.  Every year individuals decide to advance scientific knowledge and available medical therapies by volunteering to participate in clinical research.  By definition clinical research involves uncertainty and I can only imagine how that must feel.  It can’t be easy.  As a clinical researcher I am extremely grateful for your bravery and selflessness.  You truly are a medical hero…to me and to others.

Having said that, I want to reassure you that each clinical study is based on rigorous scientific principles and many years of preclinical research have been conducted before an investigational product or treatment is ever given to an individual.  The monitoring and oversight of clinical research is substantial.  There are special groups of individuals, independent ethics boards, who are charged with protecting the rights and well-being of those of you who participate in clinical trials.   If they feel the risks outweigh the benefits, they mandate changes or refuse to allow the studies to proceed.  The research is overseen by highly trained individuals and a medical doctor will always be involved for any medical care required.

There is a fundamental difference between health care and research and that must be clear to all involved.  Health care is individually focused; what care do you need to get better.  Research sets out to answer a question about whether a new product or treatment works for a population with a disease or condition.  While it may not benefit you directly, it may benefit others.

As a nurse I can impact an individual’s health.  As a clinical researcher I can impact the health of millions of individuals.  Thanks to you, I have been blessed with the ability to do both.  

Terri Hinkley
Interim Executive Director, ACRP

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Terri Hinkley
Interim Executive Director, ACRP

Terri is the Interim Executive Director at the Association of Clinical Research Professionals (ACRP).  She has recently moved into this role after spending 1.5 years as the Deputy Executive Director at ACRP with responsibility for all programs, business development, sales and marketing/communications.  Terri joined ACRP in September of 2013 after 18 years in the clinical research industry.  Formerly the director of clinical operations at Helix BioPharma Corp. in Aurora, Ontario, Canada, for which she successfully implemented a clinical operations program, Terri more recently put her experience in translating strategy into operations to use as an independent clinical research consultant and as a program coordinator for the clinical research curriculum at Seneca College. She also has worked in leadership positions for Anapharm Inc., Apotex Inc., and Biovail Corp. International; held longstanding Emergency Department duties with the Rouge Valley Health System and instructor duties for the Michener Institute’s Clinical Research Associate Program; and was a founding member of the Canadian Association for Independent Clinical Research.

Terri graduated from Centennial College’s Diploma Nursing program in 1986, after which she gained experience in Medicine, ICU and Emergency.  She completed her BScN in 2000 and her MBA in 2005.   Terri continues to practice nursing in the Emergency Department of Rouge Valley Health System: Centenary site in Toronto, on a casual part-time basis.

Terri has been a member of the Association of Clinical Research Professionals since 1996, and completed her Clinical Research Coordinator certification (CCRC) in 1999.  She was a member of the ACRP Canadian Chapter’s Education Committee since its inception and had served as President of the Canadian Chapter of ACRP.  Terri was a member of the ACRP Board of Trustees, chair of the ACRP Governance Committee, and was a member of the ACRP Regulatory Affairs Committee and ACRP Nominating Committee.  

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What do you think the most important thing a potential clinical trial participant should know about clinical research when they are deciding whether to participate? What does clinical research mean to you?

I have often thought of what I – or my elderly mother or uninformed nephew—would wish to know before deciding about participation in clinical research, but it is nearly impossible to narrow the desired information to the one most important point.  On the one hand, what any individual needs to – or wishes to – know will differ and be filtered through their personal and health situation, life experiences, nature and character. On the other hand, this is because the decision is, at its core, a nuanced choice that involves a balance between often competing factors. It is not possible, for instance, to evaluate the potential benefits of the research without assessment of its risk; it is not possible, for instance, to comprehend the risks of injury or risks to privacy without knowing the safeguards to protect the participant or the compensatory measures if injury occurs or such privacy is breached.  Volunteering for research participation is weighted: there is no one right answer and there is no one most important thing.

That said, it is worthwhile to consider what important information to convey to a potential research participant or what information is necessary to understand were one considering participating oneself.  As a preliminary measure, I think that it is critical to comprehend that in the absence of clinical research, new knowledge would not be readily forthcoming; diagnoses and understanding of natural history, pathogenesis and treatments of disease would stagnate; new drugs, biologics, devices and treatments would not be developed.  When we put in contacts lenses in the morning or use an antihistamine for hay fever, we are unknowingly indebted to the clinical research volunteers of the past. When the first case of recognized measles in Massachusetts today warrants an emergent health alert (as it did in fact today) we are grateful to the normal healthy volunteers of the past who helped prove that the vaccine to be safe and effective.  The criticality of research--and our unwavering dependence on the selfless volunteerism of individuals--is important to appreciate.

But such volunteerism is not undertaken blindly or necessarily selflessly. Understanding the research objective and the potential risks and benefits of participation are critical.  The calculus will change if the participant is a normal volunteer or a medical patient with a disease, if the disease is treatable by other already approved approaches or represents an unmet medical need, if the medicines or treatments offered as part of the research are available in circumstances other than through research participation.  And the calculus will change if the risks are significant, or are significant in relation to the potential benefits.  What alternatives to participation are there?  And what are the consequences if I change my mind after agreeing to participate? Who cares (and pays) for injuries or untoward events suffered as a consequence of research? Finally, what rights and privileges do I retain, and what rights and privileges do I forego--if any—upon consenting to participate?  And, in the end, will anyone appreciate what I have done or thank me; will anyone tell me the truth about what was learned through the research, in language that I can understand? Will I know that this effort, with its inconveniences and its potential risks, was worthwhile?

Barbara Bierer
Professor of Medicine, Harvard Medical School

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Barbara Bierer
Professor of Medicine, Harvard Medical School

Barbara E. Bierer, M.D., a hematologist-oncologist, is Professor of Medicine at Harvard Medical School and the Brigham and Women’s Hospital.  She is the Program Director of the Regulatory Foundations, Law and Ethics Program of the Harvard Catalyst, the Harvard Clinical and Translational Science Award. Dr. Bierer co-founded and now leads, as faculty co-director, the Multi-Regional Clinical Trials (MRCT) Center at Harvard, a University-wide and collaborative effort to improve standards for the planning and conduct of clinical trials in the developing world.  From 2003-2014, she served as Senior Vice President, Research, at the BWH and was the institutional official for human subjects and animal research, for biosafety and for research integrity at the BWH.  She initiated the Brigham Research Institute and the Innovation Hub (iHub), a focus for entrepreneurship and innovation. In addition, she was the Co-Chair of the Partners HealthCare Committee on Conflict of Interest.  Dr. Bierer established and directed the Center for Faculty Development and Diversity at the BWH; for these efforts, she was the first recipient of the HMS Harold Amos Faculty Diversity Award in 2008. 

In addition to her academic responsibilities, Dr. Bierer served on the Board of Directors of both the Association for Accreditation of Human Research Protection Programs (AAHRPP) and the Federation of American Societies for Experimental Biology (FASEB). She served as the Chair of the Secretary’s Advisory Committee for Human Research Protections, Department of Health and Human Services from 2008-2012.  She is currently a member of the National Academies of Sciences Committee on Science, Technology and the Law.  She serves on the Board of Directors of Public Responsibility in Medicine and Research (PRIM&R), dedicated to promoting the ethical conduct of biomedical and behavioral research; Management Sciences for Health (MSH), an international organization working in partnership globally to strengthen health care, local capability, and access; and the Edward P Evans Foundation, a foundation supporting biomedical research.  She has authored or co-authored over 180 publications and is on the editorial boards of a number of journals including Current Protocols of Immunology. 

Dr. Bierer received a B.S. from Yale University and an M.D. from Harvard Medical School.

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What do you think the most important thing a potential clinical trial participant should know about clinical research when they are deciding whether to participate? What does clinical research mean to you?

A flourishing clinical research enterprise is critical in order to advance medical knowledge and practice for today’s patients, as well as for those in the future.  The information obtained from individual trials may be like small building blocks that contribute incrementally to medical knowledge, or they may yield significant breakthroughs.

Clinical research is a collaborative enterprise and depends on the voluntary participation of patients, who may or may not derive a direct benefit from the research.  Although it is not known at the start of the trial whether the individual patient will be helped, I think it is very important that all participants understand that their generous engagement in trials will add to the growing body of medical knowledge.  Protection of the study participant’s rights, privacy and safety are paramount during the entire process and research sponsors ensure that they will have resources available to answer and address any questions or concerns as they arise.  It is through trials that patients may be able to access the newest and most promising investigative therapies.  Patients and their physicians should work together to decide if a clinical trial is the best option under the specific individual circumstances.

As a hematologist-oncologist working in the pharmaceutical industry, I have often seen clinical trials provide hope and the potential for new therapies for patients whose options may be limited.   As scientific advances lead to better understanding of diseases, we are better able to design drugs capable of impacting the underlying causes.  These targeted therapies may be far more effective than previous treatment options.

In my career, I have been fortunate to work on a number of important therapies, some of which have transformed a disease which used to be fatal for most patients, to one that most patients can expect to live with for many years.  We also conducted additional clinical trials  which showed impact for one of the drugs in a number of other cancers and serious conditions.  Such therapeutic successes change not only the lives of affected patients and their loved ones, but also have a transformative effect on many of us who have been part of the research teams.  The motivation and urgency to do this important work becomes even greater as we see the tremendous difference we can make together for patients through clinical research.

Laurie Letvak
Vice President and Head of Clinical Development Policy , Novartis

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Laurie Letvak
Vice President and Head of Clinical Development Policy , Novartis

Dr. Laurie Letvak is Vice President and Head of Clinical Development Policy at Novartis, a position she has held since June 2014.

Laurie has been with Novartis for 20 years in a variety of positions.  She played a key role in the development of Gleevec® since joining the International Project Team in 2001, responsible for Global Medical Affairs.   She led the development of the Medical Affairs program, which resulted in many key studies, some of which have provided the data for new indications for Gleevec ®, including Ph+ ALL and Adjuvant GIST.   From 2008-2012, she had been the Global Program Head for Glivec and Tasigna within Oncology Global Development at Novartis.  In this role was responsible for leading the global development efforts for both drugs, including registration programs for new indications. 

Laurie assumed the position of Global Development Head for the  Critical Care Franchise  February, 2012.  In that role she was responsible for co-leading this worldwide franchise in partnership with the commercial head and in particular was responsible for the strategic development and execution of plans for development of the evolving portfolio, which focuses on specialty cardiovascular (with emphasis on heart failure) and metabolic products, particularly for lipids and atherosclerosis.

Laurie  received her undergraduate and medical degrees from Cornell University.  She did her internal medicine training at Boston University and her Hematology-Oncology fellowship at New York University Medical Center.   Following fellowship, she practiced hematology/oncology in NYC prior to joining the pharmaceutical industry. Laurie worked for Lederle Laboratories with experience in Medical Development and Business Development prior to joining Novartis in 1994.

 

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What do you think the most important thing a potential clinical trial participant should know about clinical research when they are deciding whether to participate? What does clinical research mean to you?

Every one of us, at some point in our lives, will face the daunting challenge of having to choose between medical options for ourselves, our family and our friends.  Clinical trials are playing a large and growing role among the options for patients and their health care providers to evaluate and consider.  Nearly 4,000 experimental drug therapies are in active clinical trials today and that number will continue to grow as improvements are made in detecting disease, in understanding the root causes of acute and chronic illnesses, and in discovering medical innovations.  And in the not-so-distant future it will be more common for clinical trials to be discussed during routine visits with the doctor as electronic health records and clinical research converge.

At the Center for Information and Study on Clinical Research Participation (CISCRP), we feel the most important thing potential trial participants should know is that ‘Education must come before Participation’.   For the vast majority of people, the idea of clinical trials never enters their minds.  Most people stumble upon clinical trial opportunities when faced with the sudden prospect of a serious, often life-threatening, illness for which no marketed medication is available or adequate.  The learning curve is very steep and most people must hastily navigate the unknown terrain of clinical trials invariably feeling overwhelmed and confused by the undertaking. 

There are so many steps to becoming educated and informed. CISCRP encourages prospective study volunteers to be (1) Journalistic – to leave no stone unturned and to take the time to comprehensively search for information from multiple sources including print and online resources (e.g., clinicaltrials.gov and centerwatch.com), patient and  disease advocacy groups, health and research professionals and pharmaceutical and biotechnology companies.  Many prospective volunteers contact CISCRP to conduct manual searches on their behalf for information and clinical trial listings.  There is a tremendous amount of information available today.  Be (2) an Active Learner – and ask questions until a satisfactory answer has been found.  And (3) draw from your Network of Support - include your family, trusted friends, and health care providers in the learning and evaluation process. 

There is a chance that participation may bring hope to a study volunteer and her or his family. More often clinical trials will benefit those who will suffer from the illness in the future.  And of course, all of us benefit from future interventions based on insights gleaned from today’s clinical trials regardless of whether an experimental drug is safe and effective or is harmful and ineffective.

Participation is a courageous act and there are numerous risks in clinical trials.  Even the best run studies are not completely free of risk despite the research process being highly regulated, managed by very experienced professionals with many built-in safeguards to help protect study volunteers.  ‘Education before Participation’ helps ensure that all of the facts about a clinical trial are considered and evaluated carefully before choosing whether or not to participate.

Kenneth Getz
Chairman, CISCRP

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Kenneth Getz
Chairman, CISCRP

Kenneth A. Getz is the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise.  He is also the Director of Sponsored Research and an associate professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine where he conducts research programs on drug development management strategies and tactics, outsourcing, global investigative site and patient recruitment practices and policies.  Ken is also the founder and owner of CenterWatch, a leading publisher in the clinical trials industry and an owner and board member of the Metrics Champion Consortium, LLC.

A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Ken has published extensively in peer-review journals, books and in the trade press.  He is the author of two nationally recognized books for patients and their advocates entitled Informed Consent: A Guide to the Risks and Benefits of Volunteering for Clinical Trials and The Gift of Participation, and the recipient of several awards for innovation and scholarship.  Ken has held a number of board appointments in the private and public sectors including serving on the Institute of Medicine's Clinical Research Roundtable, the DIA Foundation, the Consortium to Examine Clinical Research Ethics, and the Clinical Trials Transformation Initiative. He is on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science, writes a bi-monthly column nominated for a Neal Award in Applied Clinical Trials and has twice been nominated for a Distinguished Faculty award at Tufts University.

Ken holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Prior to founding CenterWatch in 1994, Ken worked for over seven years in management consulting where he assisted biopharmaceutical companies develop and implement business strategies to improve clinical development performance.

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What do you think the most important thing a potential clinical trial participant should know about clinical research when they are deciding whether to participate? What does clinical research mean to you?

Patients are my number one priority, and the reason I do what I do. 

My primary motivation to become an MD was to improve the lives of patients afflicted with illness.  I entered medicine to make sick people better, alleviate their suffering, and perhaps even cure their disease.  The more I learnt about the diseases that affect us and what causes them, the more I became interested in finding therapies that truly worked – by targeting treatment for every individual based on a deep understanding of their specific illness/disease.  I also learnt that despite the incredible advances in medicine over the past 50 years, there remains an enormous unmet medical need, with many patients still suffering with diseases and their consequences for which our current therapies do not meaningfully improve their health.  This represents a great opportunity for novel solutions and new medicines that specifically address this need. 

This influenced me to enter the world of drug discovery, research and development.  The ability to really make a difference in all patients’ lives, not only one patient at a time, was very compelling to me. As an MD in practice, I could only apply the therapies that were available, while in the discovery and development of new medicines I could be more impactful in changing the landscape of available therapeutic options.  It is only through research and development of new medicines that new groundbreaking treatment can be brought to the many that are still not adequately treated. 

Discovering and developing new medicines, while exciting, is not straightforward.  At the heart of the process it is vital that we conduct rigorous clinical studies that accurately evaluate the benefits and potential risks of new medicines in the very patients for whom they are intended to treat. Fundamentally we cannot bring new medicines to those in need without the very patients who need them.  It is essential that clinical studies include a wholly representative patient population so that the results of the studies are relevant for, and applicable to, the overall patient population that suffers with the specific disease that we are developing the medicine to treat.  As such, I personally feel an enormous responsibility to the patients in our clinical studies, and I am committed to ensuring the safety and well being of every patient that we include in our studies.  They are an important, integral part of the complex process of bringing innovative new medicines to those who need them and we owe all patients enrolled in clinical studies so much. Without their bravery, commitment and dedication, continued advances in medicine are not possible.     

Darryl Sleep
Senior Vice President, Head of Clinical Science and Asset Strategy for the Cardiovascular and Metabolic Therapeutic Area Unit , Takeda Pharmaceuticals

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Darryl Sleep
Senior Vice President, Head of Clinical Science and Asset Strategy for the Cardiovascular and Metabolic Therapeutic Area Unit , Takeda Pharmaceuticals

With extensive global clinical and industry experience across multiple therapeutic areas Darryl Sleep, M.D. is Senior Vice President, Head of Clinical Science and Asset Strategy for the Cardiovascular and Metabolic (CVM) Therapeutic Area Unit (TAU) at Takeda Pharmaceuticals.  He leads the clinical science group as well as the program leaders within the CVM TAU that covers a wide pipeline portfolio including programs in the cardiovascular, diabetes, obesity, renal, and respiratory areas.

Dr. Sleep joined Takeda in 2010 as Vice President Clinical Science and Therapeutic Area Clinical Head for Cardiovascular, GU and Renal, where he oversaw the development strategy and clinical programs within these therapeutic areas. In 2011, Dr. Sleep was appointed Head of the Biological Sciences and transformed the group into Exploratory & Translational Development responsible for the translation of Takeda’s pipeline from pre-clinical to early clinical development, working with both the research and development functions to establish proof of mechanism and proof of concept for drugs in development. In November 2012 Dr. Sleep was appointed Head of Clinical Science and Early Development in TDC Americas, integrating the clinical group from Exploratory & Translational Development into Clinical Science. Dr. Sleep was appointed as the Global Head of Clinical Science in September 2013 with oversight of all Takeda’s the regional clinical science organizations before an internal realignment within R&D at Takeda resulted in him taking on his current role in the Cardiovascular and Metabolic TAU.

Prior to joining Takeda, Dr. Sleep served as Project Director in the Dyslipidemia Therapeutic Area, Global Pharmaceutical Research and Development at Abbott Pharmaceuticals. In this capacity he led four drug development programs and a multifunctional team, which included clinical development, regulatory chemical manufacturing control and drug supply, clinical pharmacology/safety pharmacology, discovery, medical affairs, medical information, and commercial/marketing. He led the multifunction team at Abbott responsible for the phase 3 development, NDA submission and approval of Trilipix in 2007 as well as the label negations for Certriad in 2009/10.  Prior to this, he held the position of Project Director in Abbott’s Oncology Therapeutic Area, where he led the phase 2/3 development of atrasetan which resulted in an NDA submission in 2005. 

Dr. Sleep received his bachelor of medicine and bachelor of surgery (MBBCh) from the University of the Witwatersrand Medicine School in South Africa. Dr. Sleep also completed his urology training with the University of Witwatersrand, and received a Fellowship of the College of Surgeons from the College of Medicine, South Africa. Dr. Sleep served as the acting Head of the Division of Urology of the Department of Surgery at the University of the Witwatersrand and Head of Urology at the Johannesburg Academic Hospital from 1995 to 1997 before being appointed as Professor of Urology at the University of Pretoria and Academic Head of the Department of Urology at Kalafong Academic Hospital, in Pretoria, South Africa. 

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What do you think the most important thing a potential clinical trial participant should know about clinical research when they are deciding whether to participate? What does clinical research mean to you?

The most important thing for a potential clinical trial volunteer to know about clinical research is how invaluable a contribution it is to participate.

Recruiting volunteers to participate in clinical trials is a well-known and enduring obstacle to research progress, and the effect is staggering: 85 percent of trials across all diseases face delays and 30 percent never even get off the ground due to low enrollment. And Parkinson’s disease (PD) trials are no exception – fewer than 10 percent of Parkinson’s patients participate.

Today, there are more promising Parkinson’s drugs in the development pipeline than we’ve seen in decades, if not ever. In the context of this encouraging progress, the participation of Parkinson’s patients and control volunteers in PD research is critical to sustaining this momentum.

In the clinical research landscape, no amount of funding or other resources can ever make up for a lack of clinical trial volunteers. That’s why The Michael J. Fox Foundation has prioritized removing barriers to participation. For example, our online trials matching tool Fox Trial Finder (foxtrialfinder.org) has nearly 46,000 registered volunteers who receive custom lists of ongoing PD trials in their area based on their medical condition, family history and more.

Further, this April, we launched Fox Insight, a virtual clinical study and online portal to additional research opportunities that allows volunteers to participate from the comfort of home. Sixteen-hundred participants have signed up so far, and later this year we plan to integrate the collection of objective data through wearable devices.

Clinical trial participants are as critical to Parkinson’s drug development as the scientists, clinicians, industry folks and billions of dollars that go into bringing one new treatment to market. So rather than tell you what clinical research means to me, I went straight to the source and asked some of them:

“Clinical trials are crucial in finding a cure and better therapeutic options for those currently living with Parkinson’s. It’s a selfless act to participate in a clinical trial, and means the world to all of us involved in this fight.” – Felicia Gordon, family member has Parkinson’s

“Many people believe that clinical trials will benefit the next generation. I believe the trials being conducted TODAY have a chance of bringing benefit to those that participate NOW. – Steve DeWitte, person with Parkinson’s

“When I was diagnosed PD, I didn’t like it when I heard that there was nothing that could be done, when indeed there is – participate in clinical trials!” – Claudia Revilla, person with Parkinson’s

“I choose to use my energy for positive action, and participating in clinical trials gives me a sense of control over the disease. People need to be involved for better treatment options, disease modifications and a cure to be found. So why not me? How about you?” – Jill Baldwin, person with Parkinson’s

Claire Meunier
Vice President of Research Engagement, MJFF

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Claire Meunier
Vice President of Research Engagement, MJFF

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As Vice President of Research Engagement at The Michael J. Fox Foundation for Parkinson's Research, Claire manages efforts related to community education and clinical trial recruitment for the research ecosystem. In this capacity, Claire leads Partners in Parkinson's, MJFF's multi-million dollar partnership with industry to inspire patients to build a care team, as well as the Foundation's thought leadership on clinical trial recruitment, including advising Foundation-funded trials on recruitment strategy and overseeing Fox Trial Finder. Prior to joining MJFF, Claire earned her MBA from the Kellogg School of Management. Before that, she was the Special Projects Manager in the department of geriatrics at Mount Sinai School of Medicine in New York City. In this capacity, she managed a national initiative in geriatric education, leading the collaborative activities of clinician-educators from 30 leading medical schools in the creation and dissemination of medical education materials. Claire holds a BS from Vanderbilt University in human and organizational development with a concentration in leadership and organizational effectiveness.

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What do you think the most important thing a potential clinical trial participant should know about clinical research when they are deciding whether to participate? What does clinical research mean to you?

Participating in clinical research is very important. It helps us develop new medicines, potentially helps the patient’s own condition, and contributes to our knowledge about disease. Without volunteer participation, therapeutic improvement would not be possible.

It is important to know that you are participating in a really worthwhile project that it is relevant to you and others with your condition. It is also important to know that it is a commitment, and to make sure you have the time and the patience to go through with it. Therefore, it is important to know as much as you can about the nitty-gritty details of the study. You should be aware that all clinical experiments carry some risk. However, at the end, it will be your willingness to help that counts.

To me, clinical research basically means the same as it does to my patients. Seeing patients in my office is very important, as it helps them with their individual problems. Doing clinical research elevates this onto a broader platform: it helps a multitude of patients with the same condition. And it is interesting, challenging, and keeps me informed about the cutting edge of my profession.

Robert Hardi
Medical Director, Chevy Chase Clinical Research

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Robert Hardi
Medical Director, Chevy Chase Clinical Research

After graduating Summa cum Laude from Semmelweis University Medical School in 1972 in Budapest, Hungary, Robert Hardi, MD spent four years in basic science, finishing with a post-doctoral fellowship at the State University of New York/Roswell Park Cancer Research Center in Buffalo, N.Y. Dr. Hardi completed his training in Internal Medicine at Semmelweis University Medical School, Hungary, Hannover University Medical School in Germany, and the University of New Mexico Medical School in Albuquerque. He also completed a fellowship in Hematology/Oncology at the University of New Mexico Medical School, and a fellowship in Gastroenterology at Cornell Medical College/The New York Hospital in New York, NY.

Dr. Hardi has been in the private practice of Gastroenterology and Internal Medicine since 1984, and is on the Clinical Faculty of George Washington University and Georgetown University. He is Board Certified in both Internal Medicine and Gastroenterology and is a Certified Physician Investigator. His principal professional interests are inflammatory bowel diseases (he has served on the National Board of the Crohn’s and Colitis Foundation of America), clinical research, procedural sedation, colon cancer surveillance, and pancreatic and biliary disorders. He serves as Medical Director of Chevy Chase Clinical Research for the Metropolitan Gastroenterology Group division of Capital Digestive Care.

In his spare time, Dr. Hardi enjoys reading, music, and travel.

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04/15/15: Cancer care advocates share their thoughts on payment and delivery reform.

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Contributors:

      
Linda House, President, Cancer Support Community
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Yanira Cruz, NHCOA President and CEO, NHCOA
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Edith Mitchell, M.D., Clinical Professor of Medicine and Medical Oncology, Thomas Jefferson University
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