Dr. Susan Love Research Foundation | Breast Cancer

When the Journal of the American Medical Association (JAMA) published an article in July 2003 in which two researchers outlined the need for a comprehensive database of all clinical trials, it received virtually no publicity.

What a difference a year makes.

It wasn't long after the article appeared in JAMA that the use of selective serotonin receptor inhibitors (SSRIs)—such as Prozac, Paxil, and Zoloft—to treat depression in children and adolescents became front-page news. Driving the story were two key developments: the revelation that the FDA had suppressed information that indicated that SSRIs increased the risk of suicidal thoughts and behavior among children, and the disclosure that GlaxoSmithKline had made public only the studies that found Paxil to be helpful for children and adolescents and had kept hidden those that found the antidepressant did not work better than a placebo.

As a result of these investigations and concerns, a government advisory panel recommended in September 2004 that the FDA require that pharmaceutical companies put a "black box" warning—the most significant level of warning—on SSRIs about potential risks when used by children and adolescents.

But an even more important development followed: Almost overnight, everyone from elected officials to medical journal editors was discussing the need for pharmaceutical companies to register their clinical trials in a public database. Currently, no such database exists. (Clinicaltrials.gov lists many trials that are open to people with serious diseases, but it is not mandated that researchers register their trials, and many go unlisted.)

As a result, in September 2004, the International Committee of Medical Journal Editors (ICMJE)—a group of editors who hail from what are widely considered the most important medical journals—simultaneously published editorials in all 11 of their publications calling for the development of a comprehensive clinical trials registration database. Further, the editors announced that "all 11 ICMJE member journals will adopt a trials-registration policy to promote this goal."

Under this new policy, for a paper to be considered for publication the trial it describes must have been registered previously in a public trials registry. The new policy will apply to any clinical trial starting enrollment after July 1, 2005. Trials that began enrollment before this date and are currently underway will need to be registered by September 13, 2005, to be considered for publication.

The ICMJE is encouraging other medical journals to adopt similar policies. But even if they don't, the fact that these 11 journals are requiring this registration is bound to have a significant impact on researchers. These 11 editors oversee what are, arguably, the most prestigious medical journals. Thus, all researchers who hope to have their studies published in one of these publications will have no choice but to register their trials.

Elected officials are calling for change as well. As the medical journal editors were preparing to publicize their new policy, members of both the House of Representatives and the Senate announced that they would work to pass legislation that would require clinical trials to be registered in a database that would be freely accessible to the public.

The Pharmaceutical Research and Manufactures of America (PhRMA) is not pleased with these developments. They have called the legislation unnecessary and have said that they intend to create a website on which pharmaceutical companies can list clinical trials they sponsored for drugs that have received FDA approval.

But PhRMA's announcement drew immediate criticism from healthcare advocates and medical journal editors. The detractors noted that PhRMA was not mandating that pharmaceutical companies take part in this new database and that the companies that did take part could choose which trials they posted, which would mean the database would be far from comprehensive.

In another effort that could lead to expanded public access to clinical trials research, the National Institutes of Health announced in September that it is considering a proposal that would require all scientists who receive NIH funding to make the results of their research available to the public for free. Currently, the results of these trials are published in scientific journals, many of which charge a fee to purchase a single article.

You can read more about the proposal and read the proposal itself here.

Susan says:
The fact that the 11 journal editors, members of Congress, and the NIH have all begun to address the need for the public to have better access to the results of clinical trials is wonderful. Having free access to the findings of all clinical trials—not just the ones that have been published—will provide women with a more comprehensive understanding of what the treatments they are taking can do, how they compare to other similar treatments, and what their full range of risks and side effects are. I've been an advocate of the need for a mandatory clinical trials database for some time. I strongly feel that it is important for all publicly funded research results to be available to the public. Research should be a partnership between scientists and the participants and the data should be available to both.