Science 37 Details How to Navigate Clinical Research in the Coronavirus Era

LOS ANGELES: Science 37, the industry leader in decentralized clinical trials, today published a report examining key considerations for patient safety and business continuity in the clinical trial industry in light of the current COVID-19 pandemic.

The impact of COVID-19 is immense and well documented in the context of global health, but the impact to clinical research, trial sponsors, research investigators and trial participants has gone virtually untold. At any given moment, there are more than 40,000 ongoing global clinical trials, involving thousands of trial sites, tens of thousands of investigators, and hundreds of thousands of patients. The whitepaper, Navigating Clinical Trials in the Coronavirus Era, details steps that pharmaceutical companies might take to mitigate risks to ongoing trials.

We are seeing a significant and growing number of cases where clinical trial participants are refusing to visit hospitals or local clinics for fear that they could be exposed to COVID-19, says Jonathan Cotliar, chief medical officer of Science 37. By all accounts, we expect this issue to continue to compound over time, which makes risk-mitigation strategies an imperative to protect the safety and well-being of participants and to enable business continuity.

At the heart of Science 37's recommendations is to incorporate telemedicine investigators and at-home nurse visits to replace clinic visits. The majority of all clinical trial visits can be conducted remotely with the help of today's technology and network of investigators who are trained to manage both the technology and the participant relationships. In addition, mobile research nurses, taking all CDC-recommended precautionary measures, can be deployed to visit participants at home to collect blood and biospecimens, monitor vital signs, complete protocol-specified procedures and capture data through the use of a virtual trial platform.

Beyond the need for risk-mitigation, many patients prefer remote investigator visits and one-on-one home visits with a healthcare professional rather than having to travel to a research site or even a local lab for a blood draw.

For clinical trials that are currently in flight, FDA regulations allow for expedited changes when submitting amendments to IRBs that relate to immediate hazards to participants. For future trials, sponsors now must design their trials with these risk-mitigation strategies already in mind.

The report describes key considerations for virtualizing protocols to minimize in-person interactions to maintain public health, particularly for those who are most vulnerable.

The whitepaper is available as a free download on the Science 37 website.
(PRN)

Like This Article?
Science 37 Details How to Navigate Clinical Research in the Coronavirus Era