What we know about drug studies is about to change

Drug studies have the power to shift treatment options for life-threatening illnesses, yet the results aren’t always made available to the public. Government health officials are hoping to change that with a major policy update announced today.

The U.S. Department of Health and Human Services and the National Institutes of Health said that while clinical trials have improved over the years, scientists conducting the research need to be held accountable so that the public can have timely access to clinical trials in progress and their final results – whether the findings are positive or negative.

The problem, they said, is that when a study’s results are disappointing – a promising new drug formula turns out not to work the way its developers hoped, or people experience unacceptable side effects, for example – the findings were often swept under the rug and not published. 

In a press conference, officials said the public has the right to know those negative results, too.

To make this happen, HHS is issuing a final rule with requirements on how and when researchers should register clinical trial information and submit results to ClinicalTrials.gov, a public online portal where anyone can go to read up on current clinical trials.

Most clinical trials receiving NIH funding will be required to participate, under a new policy NIH announced in unison. The studies will have to register in the ClinicalTrials.gov database within 21 days of enrolling their first participant, and final trial results must be posted no later than one year after a study is completed.

The rules will apply to most studies of drugs, biological products and medical devices regulated by the FDA. In addition, scientists conducting NIH-funded behavioral studies and phase 1 clinical trials – where a new drug or treatment is given to a small group of people for the first time to evaluate safety, safe dose range and side effects – will also now have to share information. 

The move will address a problem that’s existed for years: delayed, partial or no reporting of clinical trial results.  A study in The BMJ from 2012 revealed that fewer than half of NIH-funded trials were published in peer-reviewed journals within 30 months of when they wrapped up. And one-third of completed trials went unpublished after almost four years.

“Our goal is to have all NIH-funded trials in ClinicalTrials.gov,” NIH Director Dr. Francis Collins said in the press briefing. “Access to more information about clinical trials is good for patients, the public and science.”

The new policy “has some teeth,” he added, and will help maximize the value of clinical trials, whether publicly or privately funded.

In addition to the time requirements, researchers will also be asked to report information on the race and ethnicity of participants, and data on adverse effects.

NIH is the country’s largest public funder of clinical trials, investing more than $3 billion a year in drug studies, Collins and colleagues wrote a comment published today in JAMA, the Journal of the American Medical Association. They noted that researchers and NIH staff will need to undergo training to make sure the standards are adhered to, and that peer reviews of clinical trial applications must be conducted by leading experts in the appropriate field of medicine.

“To realize the benefits of a clinical trial, the data must be broadly shared quickly after the trial has concluded,” the authors wrote.

Researchers and sponsors who don’t comply with the requirements may suffer financial penalties; Collins said in the press briefing that NIH would withhold clinical trial funding to their institutions.

Dr. Emma Meagher, vice dean and chief clinical research officer at Perelman School of Medicine at the University of Pennsylvania, told CBS News, “Overall, it’s a good move. Institutions have really struggled to do this.”

The threat of penalties would light fires under researchers, she predicted. “There haven’t been any real consequences for people who haven’t posted data. But the new penalty that may jeopardize future funding is a wonderful carrot.”

She said the scientific community has had a lot of input, and she anticipates that the new requirements will be “reasonably well received by the research community.”

One negative though, said Meagher, is that institutions may take on more financial burden as a result.

“The cost of doing clinical research has increased exponentially over the last decade, driven in part because of the level of review required prior to initiating research, the level of compliance necessary in actually executing research, managing the reviews – all costs not covered by federal grants or the private sector,” said Meagher, who would like to see NIH​ allocate more funds to academic centers along with the new policies.

She said the ClinicalTrials.gov website is also cumbersome for the lay public to use. She said she hopes, as more information is added to it, that can be made more user-friendly for people interested in learning about and participating in drug trials.

“If done the right way, it’ll provide language in a public portal that consumers will be able to read, understand and act upon,” she said.

At the press briefing, FDA Commissioner Dr. Robert Califf, expressed confidence that the changes would benefit both healthy people and those with serious diseases who volunteer for clinical trials.

“This, is in my view, is a really exciting statement that we’re going to hold true to that pledge we make when we do research on people, to make that general knowledge available,” Califf said.

 


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