PhRMA Clinical Trial Registry Proposal

In 2002, PhRMA published its Principles on the Conduct of Clinical Trials and Communication of Clinical Trial Results (‘Principles’).  In this document PhRMA member companies committed to disclosing the results, positive or negative, of ‘hypothesis testing’ clinical trials.  In September of 2004, PhRMA launched a Clinical Study Results Database (ClinicalStudyResults.org) to provide a centralized repository for this information in a standard format and presentation. 

In keeping with their commitment to transparency in the area of clinical trials, PhRMA member companies support the registration of new and ongoing clinical trials.  Registering clinical trials will provide the medical research community, practicing physicians, and patients important information on ongoing clinical trials and a more direct link to the results of those trials that are completed after the implementation of this proposal.

The innovative pharmaceutical industry is committed to increasing the transparency of the clinical trials our member companies sponsor.  We recognize that there are important public health benefits associated with making clinical trial information more widely available to healthcare practitioners, patients, and others.  Such disclosure, however, must maintain safeguards for individual privacy and intellectual property, as well as conform to other relevant legal requirements. 

We thus commit to the following principles regarding the disclosure of clinical trial information:

1.      Consistent with the PhRMA Principles, PhRMA member companies commit to the registration of all company-sponsored hypothesis-testing (non-exploratory) clinical trials conducted on drugs and biologics marketed in the USor intended for marketing in the US, regardless of disease studied or the location of the trial. 

Registration of hypothesis-testing (non-exploratory) trials^[1] for both investigational and marketed products

at inception promotes the important goal of transparency and accountability.  In addition, recognizing the global nature of drug development, and that clinical trials are conducted in many countries as part of new drug development, PhRMA members believe it is important that there be open access to information on all of these studies, not just those conducted in the United States. 

Hypothesis-testing trials are always well-controlled and allow firm conclusions to be drawn to support product claims. However, as explained in the Principles, studies that are merely exploratory in nature have significant scientific limitations. They are often highly proprietary to the sponsoring company because they reflect a company’s choices to pursue certain research strategies, to test various methods of clinical trial design, and/or to utilize certain endpoint measures.  Consistent with the PhRMA Principles, therefore, exploratory studies would not normally be registered on a public database nor would their results be published unless the results are of medical importance.

2.      PhRMA member companies will utilize the U.S.government’s (National Library of Medicine’s) website, www.clinicaltrials.gov, to voluntarily register new and ongoing hypothesis-testing studies, regardless of the disease or condition studied, and will follow that site’s informational and timing provisions as outlined in Section 113 of the Food and Drug Administration Modernization Act (FDAMA).
PhRMA member companies already have a legal responsibility to register trials that test treatments for serious or life-threatening diseases and conditions on clinicaltrials.gov.  Section 113 of FDAMA, which established this registry, requires companies to register applicable clinical trials within 21 days of enrollment initiation, for the purpose of enhancing patient access to information about clinical trials in which they might wish to participate.  PhRMA member companies now commit to go beyond these legal obligations and post registration information on clinicaltrials.gov in the same time frame for all hypothesis-testing clinical trials, regardless of the disease or condition studied.   In addition, the following information will be posted:

·        Trial description in lay terminology;

·        Trial phase;

·        Trial type (e.g., interventional);

·        Trial status;

·        Trial purpose (treatment, diagnosis, prevention, etc.);

·        Intervention type (drug, vaccine, etc.);

·        Condition or disease studied;

·        Inclusion / Exclusion Criteria (gender, age, etc.);

·        Site Location (city) and/or contact information.

PhRMA member companies are free to provide additional information beyond these requirements.  PhRMA member companies are also prepared to explore the concept of placing the full protocols for these studies in a secure, non-public third-party electronic repository for subsequent disclosure to medical journals when publication is sought.

3.      Trials posted to clinicaltrials.gov are given a unique identifier. 
The unique identifier, which is already provided on the clinicaltrials.gov website, can be used to cross reference specific clinical studies in various databases and publications.  The PhRMA ClinicalStudyResults.org website will be expanded to include a field for this unique trial identifier when the study results are posted there, according to the PhRMA Principles.  This allows study inception and the disclosure of results of the study to be tracked.  Trial sponsors will also indicate on clinicaltrials.gov if a study listed in that registry has the results posted on ClinicalStudyResults.org. 

4.      Compliance.
  Member companies should establish process of verification for the clinical trial registry.  Companies are encouraged to make public how they will adhere to these standards.

5.      Timing.
By July 1, 2005, new studies meeting these criteria will be posted to clinicaltrials.gov, and by September 13, 2005, ongoing studies meeting these criteria should be posted to clinicaltrials.gov.