For physicians to make the best decisions on how to treat patients, they need information from all the clinical trials on drug treatments and preventive services. All too often, though, only select results are reported, and physicians don’t get the full picture. The AllTrials campaign, which the AMA joined in March, is aiming to change that.
Knowledge is power
Although all clinical trial results should be reported to ClinicalTrials.gov, a U.S. National Institutes of Health website that serves as a registry and results database for public and private clinical studies involving human participants, that doesn’t always happen. And to date, fines haven’t been levied against researchers who don’t comply.
AllTrials USA, a project of Sense About Science USA, in July set out to unite patient groups, professional societies, researchers, academic centers, publishers, investor groups and pharmaceutical companies to change the culture and create an atmosphere where reporting always happens. The movement started in the United Kingdom in 2013 and is calling for all past and present clinical trials to be registered and their results reported.
So far, nearly 650 patient advocacy groups, professional societies and medical organizations have supported the campaign. It’s an important movement for physicians in the exam room because they need to be able to pick the right drug for a patient and give it at the right time, Director of AllTrials USA Lauren Quattrochi, PhD, said.
“How are they expected to make the best decisions for patients without all the information?” she asked. “Physicians are ultimately the consumers of the pharmaceutical companies. They are the ones who decide if and when to use the product. Physicians have an incredible amount of skin in the game.”
Researchers also have a stake, said Quattrochi, previously a researcher at Pfizer.
If clinical trials aren’t reported, researchers do not know if they are unnecessarily duplicating efforts, Quattrochi said. They also could miss a new application for a drug. Or a study could deem a medication as not effective when it had only been tested for efficacy at the highest and lowest doses. No one may have ever tested for efficacy at the middle dose.
“That’s why transparency is so important,” Quattrochi said. “We don’t want to leave anything on the cutting room floor.”
Helping physicians and patients is what prompted the AMA to join the AllTrials effort.
“The AMA strongly supports improving the timeliness and accessibility of clinical trial data to reduce the duplication of research and help inform future research—ultimately improving health outcomes for patients,” AMA President Steven J. Stack, MD, said.
What needs to be shared
AllTrials wants three kinds of information to be made available: knowledge that a trial has been conducted, from the clinical trials register; a brief summary of the trial’s results; and full details about the trial’s methods and results.
“With the AMA’s support and support from others, we foresee huge strides,” Quattrochi said. More reporting will lead to better care for patients, more information for physicians trying to provide the best care for patients and more information for researchers to build upon, she said.
