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Bloomberg Law – Warp Speed Lessons to Cut Clinical Trial Paperwork: Woodcock

Bloomberg Law – Warp Speed Lessons to Cut Clinical Trial Paperwork: Woodcock

  • FDA acting chief aims to use Covid-19 fight to advantage
  • Electronic records can replace burdensome paper forms

Physicians running clinical trials may have less paperwork in the future by relying more on electronic health records and telemedicine, acting FDA Commissioner Janet Woodcock said.

Woodcock, who stepped away from her role as the Food and Drug Administration’s longtime drug chief last year to work on Operation Warp Speed, said Friday the therapeutics group she headed under Warp Speed is compiling a list of lessons learned with opportunities to streamline future clinical trials.

“It’s going to be a long list,” she said. “We were really impeded—and we still are—by too much trial bureaucracy and unnecessary repetition of all kinds of things.”

Woodcock, who is one of the frontrunners for the permanent commissioner’s post, has been saying for months she wants to revamp the clinical trials enterprise so that more studies are being done in community settings where patients receive their care. Meanwhile, the Covid-19 pandemic has compelled changes in cancer clinical trials to move to telemedicine and running tests near their patients’ home, and these are changes Woodcock indicated she wants to see made permanent.

Specifically, Woodcock said she wants to streamline the informed consent process, which often involves a legal document that can run tens of pages long, to make better use of EHRs, which she said are getting better at substituting for paper participant forms for clinical trials. All these changes will make it easier for smaller community providers to run trials as they typically don’t have the infrastructure of a large academic medical center.

“If we can move to those innovations, we’re going to help those practitioners out in the community participate because there’ll be fewer forms,” she said.

Woodcock spoke during a virtual event about broadening the criteria for who can participate in cancer studies, which Friends of Cancer Research and the American Society of Clinical Oncology proposed earlier this year. If successful, it would double the number of patients with the most common type of lung cancer, non-small cell lung cancer, who can participate in clinical trials.

Drug companies and researchers often copy eligibility criteria from study to study, which can leave out groups and contribute to a lack of diversity in clinical studies.

Both Woodcock and Ned E. Sharpless, director of the National Cancer Institute, indicated they were open to the Friends-ASCO proposals.

Eligibility criteria deserve a careful look and they have to make sense to the trial in question, Sharpless said. “Just copying and pasting from your last clinical trial, you shouldn’t do that,” he said. There’s a growing acceptance across the board that this practice “is bad for everybody.” “It’s bad for patients, it’s bad for progress.”

Woodcock recommended running arms of trials for patients with renal failure and other conditions that may fall outside the main efficacy evaluation but will contribute important safety data.

“We need to go a little bit further,” she said. “And so, we are opening scientifically that main trial as much as possible for those who contribute to the evaluation, and then do safety studies in other populations who are undoubtedly going to need that drug” and who it turns out to be effective for.…