The US heavily relies on clinical trials to test the efficacy and safety of various pharmaceuticals, medical devices, procedures, and treatments. The rapid spread of the novel coronavirus has created a phenomenal need for testing of devices and pharmaceuticals alike to find the most optimal treatment for COVID-19 patients.
On April 8, 2020, Business Wire reported that Continuum Clinical, partnered with the Association of Clinical Research Professionals, has an ongoing quantitative study that currently conveys a disturbing trend in clinical research. 31% of the studies surveyed revealed that they are afraid of complete closure of their study amid stay-at-home orders for most states in our nation. Additionally, the amount of fear that patients are experiencing concerning any interaction with healthcare professionals, in light of the possibility of COVID-19, exposure is spiraling. The overwhelming results of the survey show that 80% of surveyed sites indicate that at least one of their current trials have been either postponed or canceled.
FDA Urges Virtual Clinical Trial as COVID-19 Spread Aggressively
On April 2, 2020, the Food and Drug Administration released the FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic. The guidance report advised that clinical trials shift to a virtual modality to protect all participants and study teams as well as quell the fears of participants (which provokes reluctant participation).
Pre-pandemic, many patients did not know about telemedicine, but with the passing of the CARES Act, telemedicine tech is now in the forefront. With the usage of virtual visits and remote monitoring, real-time vitals such as blood pressure, pulse/ox, and blood glucose can be taken by the patient or caregiver in the home. Phone interviews are also advised. One of the questions raised by sites that are trying to have a seamless continuum in their trial is how will the participant receive the administration of the experimental treatment? It comes down to engaging the patient in the process through self-administration, making it ultra-urgent that the patients remaining in the study have demonstrated compliance.
Mitigating Clinical Trial Risk With Technology
Not only is the mitigation of the risk of exposure handled with virtual clinical trials, but the process also releases the power held in decentralizing studies. If the virtualization of a study is carried out properly, study teams will find that engagement will not only return but a surge will likely take place. Conducting trials virtually also opens up the geographic territory requirements for participants.
A successful virtual clinical trial must include (but not limited to):
- Electronic consent that is compliant while being captured remotely
- Remote visits via telemedicine
- Remote sites should have the ability to upload source documents for teams to monitor the remote data
COVID-19 Pharmaceutical Trials
The COVID-19 pandemic and the subsequent aggressive spread within the United States have ramped up clinical trials regarding medications to stop the virus from replicating to vaccinations to alternatives for ventilators.
Pharma’s response to the surge in confirmed cases and subsequent deaths evolves every day. Pharma giants like Pfizer are testing existing medications for treatment. The drug Xeljanz is under R&D for repurposing to fight COVID-19 along with a possible vaccine. Fujifilm is testing their existent candidate Avigan as treatment.
Free Resources Available to Assist Virtual Trials
On March 31, 2020, Cleveland-based Saas provider Datatrak announced that they would be waiving the license fees for their Datatrak Enterprise Cloud EDC software for all COVID-19 trials after recognizing the opportunity and responsibility they have to impact the fight against the virus materially. Datatrak ensures all researchers that are working on contributions to vaccinations and effective treatments will have free access to their platform for the facilitation of virtual teams and the collaboration and execution of their clinical trials as it relates to the novel coronavirus.
Maryland-based Advarra announced on March 26, 2020, that they are offering free research compliance resources. The initiative is in support of the clinical research community so that ongoing research can be done safely during the current spread of COVID-19. The resources offered include:
- Complimentary transferred IRB oversight
- Access to updated Forte eRegulatory management program
- eReg Lite
- access to “Ask Advarra” for the efficient guidance on issues that have arisen from the COVID-19 crisis.
Fighting in Unison
With the aggressive communication of COVID-19, all aspects of medicine and life science are coming together alongside medical device engineers and manufacturers to fight this virus on the frontline and protect the lives of those who have contracted it and decrease the number of confirmed cases.