[neverdem]

Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation

Bias, Spin, and Misreporting: Time for Full Access to Trial Protocols and Results

[texgal]

In my job at a major medical center, I monitor drug and device trials in humans and animals. Some researchers are very good and are aware of the reporting regulations while others are not. More work needs to be done at the local/institutional level to ensure that proper reporting of adverse events, severe adverse events and other requirements.

We've seen entire studies where not one single adverse event has been reported during the study and gone in and audited only to find many unreported AE's. This is why you end up with drugs like Avandia killing people.

[pieceofthepuzzle]

If the FDA and consumer advocates want to ensure earlier publication of trial results, and to ensure inclusion of all study data and findings, then they should advocate for a peer-reviewed, perhaps FDA-sponsored journal that is specifically and exclusively dedicated to publishing full trial design and results papers. It is sometimes difficult to publish clinical trial results in independent peer-reviewed journals, especially if the results are negative.

Another thing to keep in mind is that drug companies have a big incentive to not hide side effects. If their drug is marketed, and then a significant number of patients develop these side effects post-marketing, they will have to pull the drug and face significant lawsuits. For larger companies that already have a repertoire of marketed drugs, the risk is too great to continue development of new drugs that have significant side effects. Actually, some drugs under development with what many would consider acceptable side effect profiles are shelved by the companies because they don't want to take the risks.

Having said that, human beings work at and run companies, and it is certainly conceivable that individuals within those companies hide data. Oversight is key.