Has the pandemic changed clinical trials forever?


The option to take part in clinical trials through remote monitoring and virtual visits could help with recruitment, especially for those with multiple comorbid health conditions who find it difficult to travel, say researchers. Some aspects of pandemic-related trial conduct can and should remain moving forward, experts say, but caution is still warranted.

Conducting study visits remotely should only be done with careful consideration for clinical trials to provide the highest quality evidence, warn experts from Northwestern University and the University of Pittsburgh in the US, in a Viewpoint in JAMA.

With hundreds of trials still suspended due to the pandemic and others facing ongoing problems with enrolment, remote options for data collection have increased, they write. A survey of 245 clinical trial investigators in 2020 showed that the proportion of remote interactions – including posting devices such as pulse oximeters or delivery of medicines, as well as phone or web-based visits – increased from 9% to 57%.

The researchers give an example of one trial in which a randomised, double-blind, clinical trial of fluvoxamine in patients newly diagnosed with COVID-19 was done entirely remotely.

Eligibility screening was done by email and telephone and COVID diagnosis confirmed using electronic health records. Informed consent, baseline and follow-up self-assessments with a pulse oximeter, blood pressure monitor, and thermometer, were all done remotely with the drug also delivered to the patients’ door. Outcome data was also collected twice daily via email surveys or phone.

Such an approach could remain post-pandemic as increased availability of portable devices makes remote monitoring possible, they said.

But they added: “Some evidence justifies caution before abandoning or greatly reducing in-person visits for evaluation of clinical trial participants.”

Dr Laura Coates, NIHR clinician scientist at the Oxford Psoriatic Arthritis Centre who was not involved with the JAMA Viewpoint, said there was definitely interest in whether more clinical trials visits could be done remotely in the future through phone calls or apps, etc.

“There are issues with patient reported outcomes via questionnaire not always fully reflecting disease activity,” she told the limbic. “It reduces burden for patients and a hybrid model is probably ideal allowing some clinician assessments but some PROs in between.”

She added there was also the potential for some wearables, such as accelerometers or fitbit type devices, to measure sleep and activity as part of the trial process.

Dr Taryn Youngstein, consultant rheumatologist at Hammersmith Hospital and an honorary clinical senior lecturer at Imperial College London said: “The legacy of the pandemic in terms of research will hopefully be to normalise recruitment of patients to clinical trials in all aspects of medicine.” She said involving patients in the design of post pandemic clinical trials in hospitals will help to realise this vision.

“Much work had already been done on involving patients in research, and the pandemic has reinforced that we can have remote visits, use technology (such as postal blood samples and PROMS apps) to enable clinical research.”

But she added that for the foreseeable future post-pandemic and post-BREXIT funding may prove to be the biggest barrier to clinical trial research.

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