HHS Issues Proposed Rules To Improve ClinicalTrials.gov

November 20, 2014 in News

On Wednesday, HHS proposed new rules that would strengthen requirements for researchers to post the findings of government-funded clinical trials to ClinicalTrials.gov, even when such findings go against the interests of drugmakers, the Wall Street Journal‘s “Pharmalot” reports (Silverman, “Pharmalot,” Wall Street Journal, 11/19).

Background

ClinicalTrials.gov was launched in 1997 to help people gain access to information on clinical trials.

In 2007, FDA issued rules requiring researchers to publish a results summary on ClinicalTrials.gov for all eligible clinical trials within a year of the study’s completion (iHealthBeat, 5/2/12).

However, only about 15,000 of the roughly 178,000 clinical trials currently registered on the site have summaries of the trials’ results.

Details of Proposed Rules

The proposed rules would require researchers to post summaries of government-funded clinical trials for products that are not yet licensed or approved in the U.S., in addition to posting the main study results and accompanying tables with data on any adverse events. The rules also detail when and by whom such data would need to be posted.

According to NIH officials, the proposed rules would increase the number of summary results posted to ClinicalTrials.gov per week to between 200 and 250 summaries of clinical trials’ results (“Pharmalot,” Wall Street Journal, 11/19).

In addition, a new policy introduced alongside the proposed new rules would require study results of federally funded clinical trials to be published even if they are in the early clinical trial stages.

NIH Deputy Director Kathy Hudson and NIH Director Francis Collins in an article published Wednesday in the Journal of the American Medical Association wrote that without the proposed rules, “incomplete knowledge can … be incorporated into clinical guidelines and patient care.” In addition, they wrote, “Without access to complete information about a particular scientific question, including negative or inconclusive data, duplicative studies may be initiated that unnecessarily put patients at risk.”

Reaction

Scripps Health Chief Academic Officer Eric Topol said that the proposed rules would not cover many trials in their early stages of diagnostics, drugs, imaging or medical device products in development. However, he said the proposed rules indicate that federal officials are “definitely moving in the right direction towards open science and open medicine” (Burton, Wall Street Journal, 11/19).

Yale University cardiologist Harlan Krumholz said the proposal was “a bold move that is so needed,” adding, “The lack of reporting and publication has been a blight on medicine, perverting our literature and impeding our ability to see the truth … Today is a day to celebrate a real advance in how science will be conducted going forward” (“Pharmalot,” Wall Street Journal, 11/19).

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