According to the World Health Organization (WHO), some of the world’s largest funders of medical research and international non-governmental organizations (NGOs) recently agreed on new standards for clinical trials outcomes. Funded all clinical trials, per these new standards, are required to be registered with all results publicly disclosed. By all indications, funders and NGOs who agreed to the new standards find the new requirements favorable.
Those funders and NGOs who support the statement include: the Indian Council of Medical Research; the Norwegian Research Council; the UK Medical Research Council; Medecins Sans Frontieres and Epicentre (its research arm); PATH; the Coalition for Epidemic Preparedness Innovations (CEPIP); Institut Pasteur; the Bill & Melinda Gates Foundation; and the Wellcome Trust.
As part of these newly agreed-upon standards, the participating organizations will develop and implement policies that require all trials they fund, co-fund, sponsor or support be registered in a manner available for public access. The organizations plan to develop and implement these policies within the next 12 months. In addition to the registering and tracking of results, they agreed that disclosure of information relating to clinical trials outcomes should be made available within specified timeframes or should be published in a scientific journal.
According to findings by AllTrials, an initiative calling for timely and consistent reporting of all clinical trials outcomes, close to 50% of all clinical trial results go unreported at the current time. Results are often negative in nature, which experts believe is one of the main reasons results go unreported. Yet these unreported results leave a huge gap in the medical research picture, namely the risks and benefits of vaccines, drugs and medical devices, which can be harmful to patients.
The law requiring companies to report clinical trial results has existed since 2007. It allows the FDA to fine companies who do not comply with these filing requirements up to $10,000 per day and gives them the ability to withhold funds from those in violation. Unfortunately, enforcement of the law has been severely lacking.
Keith N. Fargo, Ph.D., director of Scientific Programs and Outreach for the Alzheimer’s Association, doesn’t anticipate that requiring companies to share their data will have any chilling impact on clinical trials in general. Since there are already tremendous incentives in place for pharmaceutical companies to carry out trials with the best chance of success, the possibility of negative implications tied to the new reporting standards is a very minor consideration.
“We owe it to the participants who have sacrificed by taking part in the studies, which are sometimes uncomfortable and may carry risk, to share those clinical trial results,” Fargo said.
Fargo cites it’s the sharing of results that often motivates others to participate in future trials. The Alzheimer’s Association currently utilizes the Global Alzheimer’s Association Interactive Network (GAAIN), the first open access Alzheimer’s platform of its kind designed for discovery, collaboration and sharing of information regarding Alzheimer’s disease.
“Clinical trials are the way forward. At the Alzheimer’s Association, we’re cognizant of the fact that Alzheimer’s is a fatal disease. The way we’re going to beat it is through clinical trials,” Fargo said.
Sile Lane, head of International Campaigns and Policy at Sense about Science, which runs the AllTrials campaign, commented that the new standards have positive, far reaching benefits for all involved in clinical trials, including patients, researchers and doctors.
“It’s great news for the patients who volunteered for clinical trials that have never published results, for the researchers re-running trials that they don’t know already happened and for all of us who expect our doctors to know whether our medicines work,” said Lane.
According to Lane, “It’s especially important to see the signatories calling for the development of systems to monitor whether results are being shared. We need ways to monitor results that are missing. This will help us to celebrate the organizations who are finding ways to share results, and to call out those who are letting us down.”
Lisa Bero, board co-chair of Cochrane, a global independent researcher of medical information, noted that timely and consistent reporting of trial outcomes can be beneficial in other ways, too.
“Authors often struggle to obtain the unpublished results of trials, so this commitment will provide valuable data. Ensuring that clinical trials results are available empowers policy-makers, clinicians and individuals,” said Bero.
Overall, funders and NGOs alike are recognizing the positive impact these new reporting standards will have, causing a ripple effect within the medical community and society as a whole.
“Requiring summary results of clinical trials to be made freely available through open access registries within 12 months of study completion is good for both science and society,” said Jeremy Farrar, director of the Wellcome Trust.
Dr. Trevor Mundel, president of Global Health at the Bill & Melinda Gates Foundation, sums up implementing this new standard reporting practice in this way: “It’s an essential part of the social contract that underlies medical research.”
This article was reprinted from Volume 21, Issue 21, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »