1 in 3 Clinical Trials Goes Unreported
A study by the British Medical Journal has found that a large number of clinical trials are going unpublished.
Randomized Trials Not Repeated or Published
According to MedScape, which recently published an analysis of close to 600 registered clinical trials, it has been revealed that almost 30% of these trials have failed to be published 5 years after their completion. Also 75% of these unpublished trials were not made available at ClinicalTrials.gov.
It was found that industry-funded trials were two times more likely to be unreported than studies that had not received industry funding. Other studies have indicated that published trials contain less than half of the patient-outcomes information contained in company-controlled data.
The unavailability of results from these trials only promotes publication bias and fails to uphold the honor of the ethical contract that is crucial for exposing study participants to the risks associated in trial participation.
About the Clinical Trial Publications Study
Medical scholars from the University of North Carolina, Chapel Hill, conducted a cross-sectional analysis of trials that contained a minimum of 500 participants and had been prospectively registered with Clinical Trials.gov and completed before January 2009. The scholars’ analyzed included 585 registered trials, 171 of which (29%) remained unpublished and included 300,000 participants.
Trials failed to be published at a rate of 32% for industry-funded trials and 18% for those trials that did not have industry funding (P = .003), and 78% of the unpublished trials also failed to report trial data and information to ClinicalTrials.gov.
US Federal Policy for the Protection of Human Subjects, or the “Common Rule”, holds that study participants are necessary to expanding knowledge and safety to society as a whole in assesses a drug or product. The associated risks of randomization, blinding, and unproven interventions to which clinical trial participants expose themselves are ethically justified.
The Common Rule
According to the MedScape, the Common Rule:
- Outlines the responsibilities of institutional review boards (IRBs).
- The Common Rule directs IRBs to weigh the societal importance of resulting knowledge, as well as the possible risks to individual research participants.
- The authors suggest that IRBs are thus uniquely positioned to protect the rights of study participants throughout all stages of trial planning, conduct, and reporting.
Contact an Experienced Clinical Trial Attorney
Thomas J. Henry are leaders in the area clinical trial litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. Our Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.
If you or a loved one have been injured by or have developed serious side-effects while participating in a clinical trial, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.