Revised clinical trial rules due to Covid-19 may benefit patients in long run: Survey

The adjustments made to the clinical trials after the coronavirus outbreak, which has led to the simplification of the clinical research process, may benefit patients in the long run.

The trials have incorporated adjustments according to the ongoing pandemic. This includes utilising remote consents, conducting telehealth study visits, and shipping oral study treatment to patients’ homes.

A survey of The University of Texas Southwestern Medical Center (UTSW) clinical research professionals found that most clinical trial coordinators, managers, and nurses report positive experiences with these Covid-related adjustments. Most of them support the new protocols even after the pandemic ends.

According to the survey, 90 per cent of respondents, mostly associated with healthcare, had seen changes that had a positive impact on patient safety, treatment efficacy, patient and staff experience, and communication with patients, investigators, and sponsors.

They also believe that it was important to continue any positive Covid-19-related clinical research adjustments even after the pandemic ends.

Tele-health procedures

The survey revealed that patients who had first-hand experience with the new protocols were more likely to recommend continuation. 61 per cent of respondents who had used tele-health were in favour of keeping it going, compared with 36 per cent of those who had not used this technology.

Similarly, 63 per cent of those who had been involved in shipping therapies were in favour of the practice continuing, while only 29 per cent of those without experience shipping therapies suggested the practice continue.

Lead author David Gerber, MD, a professor of internal medicine at UTSW, said in a statement: “With COVID-19, we’ve seen more changes to clinical trial practices than at any other time in my career. My hope is that this whole ordeal leads to long-term simplification of the clinical research process.”

When the pandemic raged in March, the Food and Drug Administration issued the guidance, allowing clinical researchers to make temporary changes to trial conduct, including implementing tele-health appointments and allowing electronic signatures.

FDA mentioned that this guidance remains in effect until the official Covid-19 national emergency is ended by the federal government. The National Institutes of Health also issued revised trial guidance.

The survey was published in the Journal of the National Comprehensive Cancer Network and EurekAlert!