ClinicalTrials.gov is a registry of clinical trials, interventional studies, federal and privately funded and conducted under an Investigational New Drug (IND) with the primary purpose of improving access of clinical trials specifically for individuals with serious illnesses/diseases. “The first US Federal law to require clinical trial registration was the Food and Drug Administration Modernization Act of 1997 (FDAMA), ClinicalTrials.gov was implemented in 2000. There are well over 150,000 clinical trials registered by all 50 States and approximately 190 countries. Some information that is included when a clinical trial is registered is,
- The purpose of the clinical trial (Disease or Condition)
- Title, design and description of interventional studies
- Eligibility criteria
- Location of clinical trial sites
“In 2006, a sponsor conducted a Phase 1 trial in healthy volunteers that caused catastrophic systemic organ failure in all six trial subjects. A controversy emerged because a similar study had been done in 1994 with similar outcomes. It was suggested that had the trial information been available on a public registry, perhaps the second trial would never have been conducted and patient safety would have been protected”.
“Just a year later, in 2007, the International Committee of Medical Journal Editors (ICMJE) instituted a policy whereby they would no longer publish any trial information that hadn’t been previously posted on a primary public registry. According to ICMJE policy, all trials must be registered at or before the onset of patient enrollment, as a condition for publication consideration. The rationale for this approach was to ensure a complete public record of trials run on a particular compound was available, regardless of the end result”. The FDA Amendments Act (FDAAA) “also requires clinical trial results to be published no later than 12 months after the primary completion date (the date of the last patient’s final visit for data collection for the primary outcome of the trial) for an approved product, or within 30 days of receiving a marketing authorization for a new product/indication. Results must be disclosed for all interventional Phase 2, 3, and 4 trials of FDA-approved marketed products.”
In 2008 ClinicalTrial.gov released the Results Database, the inclusion of adverse event information was required in September of 2009. “The FDA has established fines for noncompliance, starting at $10,000 for the first event and $10,000 per day for every day late (if not corrected within 30 days). Internationally, non-compliance may have additional consequences. The ICMJE can and will reject manuscripts, which means trials will not be discussed in a recognized, respected, and peer reviewed medical journal”.
Transparency has become critically important however, even though there are noncompliance fines a study was published Nov. 12, 2015 by the British Medical Journal [http://bmjopen.bmj.com/content/5/11/e009758.full?sid=ae78878f-12f0-41a0-8852-45a390a9c0a2] ”which cites a notable lack of transparency at Gilead Sciences for data supporting its HIV therapy Stribild and at Sanofi for a low disclosure rate for Aubagio to treat multiple sclerosis. At the same time, GlaxoSmithKline, Johnson & Johnson and Pfizer did better, disclosing all trial results for at least one new drug reviewed that year. “