Clinical trials professionals will have to be laser-focused as emerging technology tempts them into a fool’s paradise of big data, a top industry analyst tells CenterWatch.
Machine learning, artificial intelligence and even consumer electronic apps are offering troves of data that would have been unimaginable even a couple of decades ago, says Ken Getz, an associate professor at the Tufts Center for the Study of Drug Development.
But if sponsors, sites and investigators aren’t careful, they can lose control of their studies and see knowledge dissolve in information.
The clinical trials industry is just coming to grips with a new FDA approach to inspections that uses advanced computer algorithms to flag trials for risk.
The agency has spent the past few years preparing for centralized trial inspections and issued a draft guidance on them in February but it’s still relatively early in the process, says Cerdi Beltre, senior vice president for institutional services at the WIRB-Copernicus Group. Until trial professionals get a better sense of how the algorithm works, they should do some self-auditing, she adds.
The UK’s top cancer research agency is pushing sponsors, sites and investigators to retool their efforts to focus on cancer patients’ quality of life.
“We want to accelerate clinical research for the patient’s benefit,” National Cancer Research Institute (NCRI) researcher Feng Li tells CenterWatch. “It’s the fastest way to translate data, really, into the patient experience.”
Sponsors will have to plan carefully — and show their work — if they want to use meta-analyses to prove drugs are safe, the FDA says in new draft guidance.
Randomized clinical trials sometimes have trouble creating big enough sample sizes to detect adverse events and to determine whether they’re linked to the meds being tested. In those cases, sponsors can combine the results of multiple studies and project out safety measurements — if they carefully detail how they chose and analyzed the data, say the proposed guidelines issued last week.
Stanford University researchers last week announced they had enrolled 400,000 patients in a clinical trial to test whether an app on the new Apple Watch can effectively screen for a heart-rhythm disorder.
The trial, dubbed the Apple Heart Study, is the largest atrial fibrillation study in history. And, whatever its findings — which are due to be released early next year — some clinical trials experts wonder whether those watches aren’t just ticking out time and heartbeats — what if they’re also tolling a warning to the industry that if it doesn’t shape up it could be swallowed up?
Pennsylvania Gov. Tom Wolfe has signed legislation allowing drug sponsors to pay the expenses of patients who enroll in their clinical trials.
The new law, which takes effect immediately, makes Pennsylvania the second state after California to greenlight reimbursing participants in an effort to beef up trial enrollment and retention.
The measures make clear that the payments do not amount to coercion or inducement, clearing the way for sponsors and researchers to reimburse patients for travel and other expenses often cited as recruitment and retention obstacles.
The number of clinical trials in the UK has plummeted amid growing anxiety over uncertainties linked to Brexit.
There were a total of 597 clinical trials conducted in Britain and Northern Ireland last year, a drop of nearly 25 percent from the annual average over the previous eight years, according to a new analysis by Fitch Solutions.
The FDA left the door open to a speedier approval process for targeted therapies in final guidance issued last week.
Sponsors may get some leeway if they can show that a proposed treatment worked in clinical trials for molecularly similar diseases, or can demonstrate efficacy through computer modeling, close analyses of the molecular structures of disease variants, evidence from other drugs in the same pharmacological class or some combination of these approaches, according to the guidance on rare genetic variants of diseases.
As sponsors and sites have expanded their global reach, they’ve run into myriad local and regional regulations requiring them to report adverse events in their clinical trials. Hoping to simplify, many sponsors or sites have tried to create a one-size-fits-all form that sends out nearly automated alerts for nearly every single glitch.
“A lot of pharma companies take the approach that they’ve got to be compliant with everyone, so they say, ‘We’ll just send out everything,’” says Steven Beales, WCG’s senior vice president for safety. That might sound OK. [But] you’re wasting site hours and you’re not improving safety because you’re diluting the message.”
A Florida scientist is urging sponsors and care providers to do a better job of getting early-stage Parkinson’s sufferers into clinical trials before they start treatment.
Robert A. Hauser, director of the Parkinson’s & Movement Disorder Center at the University of South Florida and author of one of the most widely used patient diaries for Parkinson’s trials, says researchers need to recruit patients at the first sign of trouble — before they start taking meds so they have time to assess experimental therapies against placebos.