Grantees, Reveal Thy Findings: A Push By Funders for Transparency in Medical Research

photo:  Nestor Rizhniak/shutterstock

In an effort to combat research waste and speed up the discovery of new drugs, medical research funders have pledged to cut off funding to grantees who fail to meet basic transparency standards. To date, over a dozen funders, including heavy hitters like the Bill & Melinda Gates Foundation and the U.K.’s Wellcome Trust, have signed a joint statement demanding that their grantees publicly disclose the results of all clinical trials within 12 months.

“Research funders are making a strong statement that there will be no more excuses on why some clinical trials remain unreported long after they have completed,” commented Dr. Marie-Paule Kieny, assistant director-general for Health Systems and Innovation at the World Health Organization (WHO), whose standards the statement is based on.

Clinical trials conducted in human patients are the keystone of modern medicine. Typically, a clinical trial examines whether a new drug, medical device or procedure is safe and effective at improving patient health. Every year, pharmaceutical companies, government agencies, foundations and nonprofits pour billions of dollars into trials in the hope of discovering new vaccines, treatments and cures. However, around half of all clinical trials never report their results, and many others are badly reported, making no contribution to medical progress. Scientists have warned that as a result, a mind-boggling $170 billion in medical research funding is being wasted every year.

The widespread failure of industry and nonprofit researchers to share trial results has also been linked to patient deaths. In one case, American doctors inadvertently killed over 100,000 people over the course of a decade because the results of a single clinical trial remained hidden. In addition, hidden evidence complicates decision making by public health bodies. For example, a few years ago, governments spent billions of dollars stockpiling the drug Tamiflu to hedge against the threat of a global influenza pandemic. However, the results of eight Tamiflu trials had never been disclosed. When, after a fight of several years, independent scientists finally had access to all trial results, they concluded that that Tamiflu’s benefits were close to zero, leading critics to contend that public funds had been squandered on an ineffective drug.

Campaigners pushing for greater clinical trial transparency have long blasted pharmaceutical companies for concealing unflattering trial data on their drugs—this little online game illustrates how such manipulation works—but universities and other nonprofit research institutions tend to be even worse at publishing trial results. For example, data compiled by an Oxford University research team shows that the City of Hope cancer center in California has failed to disclose adequate results for over 83 percent of its clinical trials. (The City of Hope did not respond to repeated requests for a comment.)

"It's a 21st-century best practice—and an essential part of the social contract that underlies medical research—that clinical trial data should be made publicly available less than one year after a clinical trial's completion,” said Dr Trevor Mundel, president for global health at the Gates Foundation. “We strongly support WHO's effort to establish a global standard for reporting data within this timeframe, which is a practice we require of our grantees, as well." At present, many institutions only go public with trial results when a journal publishes their findings, a process that can take several years.

While some funders already require results to be posted within 12 months, compliance has been mixed at best. A search of trial registry entries suggests that medical research institutions have failed to upload the summary results of dozens of trials supported by the Gates Foundation, making it difficult or impossible for other scientists to discover whether new approaches to treating HIV, tuberculosis and malaria have been successful or not. By signing up to the new initiative, the Gates Foundation has committed to ongoing monitoring of reported results. In addition, researchers may be asked to provide a list of all their previous trials along with their publication status when applying for a grant.

"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. Not only will this help ensure that these research findings are more discoverable, but it will also reduce reporting biases, which currently favour publication of trials which have a positive outcome,” said Dr Jeremy Farrar, director of the Wellcome Trust. “Today’s statement is in line with Wellcome’s broader ambition to make all research outputs which arise from our funding more findable, accessible, and re-usable."

Other funders have been more cautious. “We are highly supportive of the principles that appear in the Joint Statement, however, some of the specific guidance in the Statement do[es] not align exactly with our policies. For this reason, NIH is unable to be a signatory to the Joint Statement at this time,” said a spokesperson for the National Institutes of Health. The spokesperson pointed out that the U.S. government agency already has a policy that requires all clinical trials it funds to post summary results on the American trial registry within 12 months. However, critics have voiced concerns that the NIH policy may lack teeth.

Past efforts to get more trial data into the open have a checkered track record. In the United States, a law passed in 2007 made it obligatory for institutions running trials to disclose their results within a year. In theory, after that deadline has passed, organizations have to pay $10,000 per day until the results are made public. In practice, many drug companies, universities and nonprofit research centres ignore the law, investigative journalist Charles Piller discovered. “If the federal government had been enforcing the law rigorously, it could have collected a whopping $25 billion from companies [alone] through [2015]. But it has not levied a single fine,” Piller explained, pointing to the power that the pharmaceutical industry and universities wield in Washington. “The government so far has not been willing to use financial penalties. NIH is not keen to pick a fight with important academic institutions, some of which have a lot of clout.” In the European Union, a similar legal provision also remains unenforced.

Confronted with an anti-regulatory environment in D.C., activists are increasingly looking to philanthropic funders to get more medical evidence into the public realm. “This group of funders and non-governmental organizations is leading the way in a much-needed move from awareness to action. Registration and reporting policy, compliance monitoring, and enforcement is now the gold standard by which other clinical trial funders and organizations will be measured,” said April Clyburne-Sherin, campaign manager of AllTrials USA. “Other clinical research organizations should see this as an opportunity to raise their standards to match. This is a turning point in our conversation about the problem of missing clinical trials.”

Across the Atlantic, longtime transparency advocate Dr. Ben Goldacre recently revealed his own plan to get more medical research funders to board the transparency train. “We have ranked the policies of non-industry trial funders,” he wrote in a blog. “And that paper will land shortly.”

Till Bruckner is the founder of TranspariMED, an initiative that develops policy solutions to end evidence distortion in medicine, and the advocacy manager for Transparify, which advocates for greater transparency and integrity in policy research. A long time transparency veteran, he has previously worked for the AllTrials campaign, Transparency International, and international development agencies.