Hundreds of clinical trials unrelated to COVID-19 are reportedly coming to a halt, and still more are otherwise affected by the virus.
Dr. David Weisman, a practicing neurologist and director of the Clinical Trial Center at Abington Neurological Associates in the Philadelphia area, has not had to discontinue any of his trials yet, but he feels strongly that new enrollment should be put on pause.
“We, as a site, are not enrolling anybody — full stop,” said Weisman in a recent phone interview. “You take an at-risk population, typically a little bit older, and you have to imagine that they are possibly going to get randomized to placebo. In which case, they have all this increased risk. And it’s not just for the study visits; there are also MRIs, PET scans, and sometimes we do spinal taps.”
Weisman’s focus is primarily on Alzheimer’s disease and other forms of cognitive impairment, but he is also currently running trials for new therapies to treat stroke, multiple sclerosis, and Parkinson’s disease.
As for those continuing to take part in clinical trials, he’s taking things “on a case by case basis. You owe it to them to give it a fair shake,” he says. And that fair shake comes with a lot of discussion and a very considered risk/benefit analysis.
“We have to make a decision, keeping two conflicting values in mind: patient wellbeing and trial integrity,” he says. “And usually these two things are exactly aligned because the trial is written for safety. These things go hand in hand, but now that is not the case because a patient could come into our office and be exposed.”
Weisman is not alone in making these decisions, in March, the FDA released guidelines for conducting clinical trials in the face of COVID-19.
“We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants,” said Dr. Anand Shah, FDA deputy commissioner for medical and scientific affairs, in this press release.
With patient safety the top priority, Weisman says the decision to continue study participation depends on many factors.
“It’s very dependent on the trial, the person, the caregiver, and the condition,” he adds. “You get a feel for the trial and how intense it is, how invasive, how many times they have to show up and what their exposure is.”
Weisman has moved as many patients as possible over to telemedicine. He has also encouraged patients who are fearful or risk-averse not to participate. Other patients have expressed enthusiasm for continuing but the risks to them or those around them are simply too high.
That said, study participation hasn’t declined too significantly. Weisman has gone from seeing about 20 people a week in person to about 15. Patients come in without caregivers, unless absolutely necessary. Everyone wears a mask, and no one congregates or sits in a waiting room.
“They go from the hallway directly to a single place that is already rubbed down. All the rooms stink of bleach,” says Weisman. “The smell of bleach makes me happy.”
Special thanks to David Weisman, MD, director of the Clinical Trial Center at Abington Neurological Associates. You can learn more about him on his provider page.
The post Finding the Balance Between Clinical Trial Integrity and Patient Safety in Non-COVID-19 Research appeared first on Neurology Insights.
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