Parkinson Pipeline Project-treatment development database, research, FDA drug approval, PD clinical trials and sponsors, patient involvement

Better Reporting of Clinical Trial Results

One centralized source of access

“Universal prospective registration of trials in a publicly accessible repository is a crucial mechanism for ensuring that trials are known about at the start, to uniquely identify them and to reveal the existence of unpublished trials.”(5) There is growing support in the scientific and advocacy communities to require research sponsors to publicly list all clinical trials — not just treatment trials for serious and life-threatening conditions — including the outcomes, in a centralized, standardized database. This would provide information to more patients and give physicians access to the most complete information they need to practice evidence-based medicine. It would also inform and speed the development of new trials and enhance the safety of research participants.

“We really need something that everyone participates in, where we have a register in a single place and you don't need to go multiple places to try find the information that you need,” said Dickersin PhD, the director-designate of the Johns Hopkins Department of Epidemiology’s Center for Clinical Trials.⁽¹⁾

"We are told that the information is accessible to us and it is in peer-reviewed journals which are good vehicles or media for this information. But what we find is that information is very difficult for us to access, and in some cases impossible,” said Sharon Terry, President and CEO of the Genetic Alliance, a patient advocacy organization comprised of 600 nonprofit groups.⁽⁹⁾

"We are told that we could go to medical libraries. Those are not always easy to get to or accessible from Middletown, Ohio, or [wherever patients] live,” she said. “We are told we can get these articles by the article from the publisher. Often the price on those articles is $35, $25, onerous when you are looking at the number of articles that we need. The ivory tower mentality of putting the fences around the information is something that we look forward to being dispersed soon.”⁽⁹⁾

Legislation

Fair Access to Clinical Trials (FACT) Act of 2005

The Fair Access to Clinical Trials (FACT) Act of 2005 (S. 470, H.R. 196) has been languishing in Congressional committees since February 2005. The legislation would require expansion of the ClinicalTrials.gov database to create “a publicly accessible national data bank of information comprised of a clinical trial registry and clinical trials results database. The database would include a clinical trials registry accessible to patients and health care practitioners seeking information related to ongoing clinical trials for serious or life-threatening diseases and conditions.”⁽¹²⁾ The FDA would also be required to develop a second database — accessible to the scientific community, health care practitioners, and members of the public — highlighting all publicly and privately funded clinical trial results, regardless of outcome. Additionally, the FDA would have to make internal drug approval and safety reviews publicly available. In order to obtain approval from a U.S. Institutional Review Board, all clinical trials for drugs, biologics, and medical devices would have to be registered in the database before they begin enrollment.⁽⁴⁾ Harsh penalties could be imposed for noncompliance.