The COVID-19 pandemic suddenly changed the clinical trials environment with impacts on all stakeholders that at first are negative, but could be positive in the long term.
There is talk of transformation that could last well beyond the crisis. Optimistic views include speculation that there could be wider adoption of practices that have languished in concept or startup mode until now. Benefits to drug developers, clinical research sites, patients and society itself are in discussion.
We observe that the COVID-19 crisis shines a light on the benefits to patients and industry stakeholders of bringing clinical trials closer to patients' homes, including through the use of independent clinical research sites.
COVID-19 has caused significant concern among patients, caregivers and healthcare providers that it is too dangerous to come into a clinic or hospital where COVID-19 patients are being treated. This includes, but is not limited to, many people with chronic diseases who have compromised immune systems.
Trial planners also have looked for alternate ways to keep trials running when staff at their usual sites is reallocated to the fight against the COVID pandemic.
Independent sites that do not treat COVID-19 patients would be an excellent alternative to pausing clinical trials. Continuing routine clinical trials work is good for drug developers, sites, and of course for patients seeking treatment for their serious medical conditions.
Trial planners are trying new technologies and methods including those for telemedicine consults, remote assessments, eConsents, and in-home medications administration. The FDA and payers have shown new flexibility and IRB boards are busy reviewing changes to research.
In this transformative time, independent sites may be faster to pivot to new ways of operating.
These combinations of telehealth, home health and local independent clinical sites reduce travel to distant medical centers and long waiting room times that have long been a burden on patients and their families. In the short term, the growing adoption of these techniques can allow clinical research to get back on track. In the long term, it has the potential to increase enrollment and participation in clinical trials, a holy grail of clinical research.
Independent sites also bring important efficiencies to the clinical trial landscape that directly benefit both patients and sponsors. The unique ability to negotiate a contract and budget in less than two weeks, along with the use of a central IRB, can significantly shorten the length of study start-up, make for earlier enrollment starts, and eventually reduce overall R&D spend.
Just as the COVID-19 crisis highlights the benefits to stakeholders of a network of nimble independent sites, it also brings business pressures that threaten the survival of some of these sites. If revenue pressures forced sites to reduce services or go out of business there could be serious impacts on patients' ability to participate in trials or get needed medical care.
To ease pressure on their site network, drug developers should consider easing up on traditional but obsolete business requirements that place financial burden on sites. For example, monetary holdbacks once made sense to be sure data was turned in, in a timely and compliant manner. Where data are delivered electronically in real time there is less need to continue such holdbacks.
The continuation of independent clinical research sites is a win for all stakeholders and contributes to an ongoing transformation that increases clinical trial participation by bringing trials closer to the home of the patient.