Clinical trials and the public interest

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Members of the public could use it to search for a specific trial in which they could participate. Clinical investigators could use it to avoid duplication of effort and obtain patients for their trials. Foundations and granting agencies could use it to gauge interest in specific areas of clinical investigation and to identify areas where studies need to be encouraged. And the media could use it to investigate what scientific studies are under way.

The maintenance of this Web site should be publicly funded, and utilization statistics could be collected to justify its continued existence and support.

"A national drug trial registry could play a role in burnishing the image of an industry increasingly under siege. On the other hand, posting sensitive trial information poses challenges for firms that invest so much time, effort and financial resources in bringing products to market especially if such information is taken out of context or reveals internal marketing strategies.

Because we rely so heavily on published sources and trial data to create the most effective promotional messages for our clients, we could be challenged if registries somehow end up discouraging research. However, increased regulation of trial data and publication standards will surely influence package inserts and the content of PDA-required 'fair balance' statements in promotional materials."

"Pharmaceutical companies have legitimate concerns over proprietary information, but the public should have access to clinical trial data, good or bad - as should the doctor in Oshkosh.

However, we already have a national registry that was set up by the FDA. Why don't we start with enforcing what we have and looking at how we can enhance it instead of reinventing the wheel? Before we jump the gun, we have to establish procedures for looking into what went wrong. Should that be up to pharma firms, or should it be handled by the FDA?

Part of the problem is that anytime there's an adverse event regarding clinical trials, the press jumps on it and things are taken out of context. If a drug has serious side effects, what were the circumstances? Accurate reporting can also encourage the public to ask critical questions so they can make informed decisions."

"The idea of a registry for clinical trials is an overreaction.The current system is not broken. In fact, over the last few years, transparency has accelerated greatly with Web sites such as clinicaltrials.gov and clinicaltrials.com.

In the Paxil case, as is true of almost all clinical trials, the data was communicated in a number of forums. That the information was not as widely disseminated is understandable, as about one third to one half of clinical trials in the investigation of antidepressant agents fail to separate the active drug from placebo because of design difficulties.

Transparency in all facets of business should be applauded. In this instance, though, there are numerous vehicles that already lead to transparency.The more important issue to address is the misleading promotion of selective trials where there is full knowledge of other trials that have shown no benefit."

" Why don't we start with enforcing what we have and looking at how we can enhance it instead of reinventing the wheel?