There's No Room for Bias in Research
There's No Room for Bias in Research
10.19.12 | By
At the heart of any productive relationship or venture is trust. In the biopharmaceutical sector, the integrity of our products, our research - and ultimately the faith that physicians and patients have in medicines - requires trust. And it's something that must be earned.
A blog post in yesterday's New York Times and a related study in the New England Journal of Medicine touch on the issue of trust, calling for greater transparency in biomedical research and inferring that bias in research or patient care is an obstacle to achieving such trust. We agree.
The practice of modern medicine requires the best available information - physicians need to know the latest developments from biopharmaceutical companies about new and existing therapies and companies benefit from feedback on patient use of medicines from physicians and other health professionals.
Our sector has gone to great lengths in recent years to embrace more mature, responsible and transparent relationships with healthcare professionals - both in the research and patient care settings.
Our Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results were strengthened in 2009 to increase transparency, help address potential conflicts of interest in medical research and assure that meaningful clinical trial results are responsibly communicated to healthcare providers and patients.
Per the Principles, biopharmaceutical research companies are committed to the timely submission and registration on clinicaltrials.gov of summary information about all clinical trials that we conduct involving the use of marketed or investigational products in patients - regardless of outcome. This robust tool is a critical resource for the healthcare community to obtain up-to-date information.
The data posted on clinicaltrials.gov and the information captured in our Medicines in Development series demonstrate the vast scope of the research conducted and supported by our sector. Among the medicines currently being tested in clinical trials or awaiting FDA review are nearly 100 for Alzheimer's disease and related dementias, more than 900 for cancer and 300 for cardiovascular disease. These potential new treatments offer hope to millions of patients battling debilitating and life-threatening diseases.
As the article points out, our sector is responsible for the vast majority of the biopharmaceutical research conducted today. This research is the pathway to new therapies for unmet medical needs and improvement to existing treatments.
Our member companies recognize that there are important public health benefits associated with making appropriate clinical trial information available to healthcare practitioners, patients and others. We believe that such data are best disseminated in a fashion that is scientifically robust and appropriately vetted by medical and scientific experts.
And we believe that there is no room for bias in research or patient care.
Any bias - including treatment choice - has the risk of depriving patients of the best therapeutic option for them.
Just as we have taken a strong position on clinical research through our Principles, our sector has stood forth to reinforce its commitment to provide up-to-date, accurate information to healthcare providers about medicines.
Our Code on Interactions with Healthcare Professionals, which was revised and strengthened in 2008, reaffirms that interactions between company representatives and healthcare professionals should be focused on informing healthcare professionals about the benefits and risks of medicines to help enhance patient care, providing scientific and educational information, and supporting medical research and education.
Importantly, the Code states that materials provided to healthcare professionals by or on behalf of a company should "(a) be accurate and not misleading; (b) make claims about a product only when properly substantiated; (c) reflect the balance between risks and benefits; and (d) be consistent with other Food and Drug Administration (FDA) requirements governing such interactions."
In other words, whether it's through our approach to clinical research and data, or through our interactions with healthcare professionals, our sector aims to earn the trust of health care stakeholders - including doctors but most importantly patients.