Releasing Clinical Trial Results, Follow-Up

Note: One of my favorite contributors to this site is a reader (that wishes to remain nameless) that has provided wonderful insight into areas like LLLT (hair lasers) and the FDA. I’m admittedly not an expert in everything (no matter how much I wish I was), and he’s corrected my initial thoughts about companies publishing ongoing clinical trial results. His email is as follows:

Dr Rassman,
As someone who has worked in the drug development industry, I try to keep your readers updated with accurate info on how this process works. One of your readers asked whether “Aderans…would send out an update on their Phase 2 trial data……..and whether there are rules requiring such info to be confidential.”

There are no rules to keep trial data confidential. The sole reason why data from an ongoing Phase 2 trial is not released is because it is not available. That is, no data is available to a sponsoring company until a drug study is complete (or in rare cases, when an “interim analysis” is done). When a company begins a trial the data (and identity of the participating patients) is kept secret from the company during the conduct of the trial. This is to ensure that no data is manipulated; extraordinary safeguards are put in place. Intentional violation of such safeguards with hiding of the act is a form of scientific fraud and would result in failure of drug approval and public sanction of the company by regulatory (and other)
authorities.

The FDA (and regulatory agencies, in general) have no jurisdiction of when a company reports data to the public (and do not care). However, public reporting of inaccurate data can result in sanctions from both regulatory agencies and, if the company is public, the US Securities and Exchange Commission (SEC). The latter relates to how public release of trial data typically affects a public stock (good data raises the stock price, bad data lowers it).

Nearly all public companies release Phase 2 clinical trial data (regardless of positive or negative) on trial completion for 2 reasons: (a) to communicate results to the scientific community, and (b) to communicate the results to shareholders. Withholding such data from shareholders can be perceived as having “inside information” of results that are considered “material” (i.e. important for shareholders to make decisions on purchase or sale of the stock). In cases where a company is private (rare when a company is at the stage of Phase 2), trial data is usually released to encourage future investors (positive data) or explain why a program is not moving forward (negative data).

Bottom line: Aderans can not send out a trial update because the data will not be known until study completion and analysis (the FDA has nothing to do with this). There are no rules to keep trial data confidential when a study is completed and, in fact, there are many reasons why public companies are required by the SEC to divulge these results. In fact, the SEC has brought legal action against some companies that they feel have not released “material” clinical trial data in a prompt fashion.