The US relies heavily on clinical trials to test the efficacy and safety of various drugs, medical devices, procedures and treatments. The rapid spread of the novel coronavirus has created a phenomenal need for both device and drug testing to find the most optimal treatment for COVID-19 patients.
On April 8, 2020, Business Wire reported that continuum clinicalin collaboration with the Association of Clinical Research Professionals, has an ongoing quantitative study that currently reflects a disturbing trend in clinical research. 31% of surveys surveyed revealed that they fear complete shutdown of their studies amid stay-at-home orders for most states in our country. In addition, the amount of anxiety patients experience regarding any interaction with healthcare professionals, in light of the possibility of COVID-19, is increasing with exposure. The overwhelming results of the survey show that 80% of the sites surveyed indicate that at least one of their ongoing investigations has been postponed or cancelled.
FDA urges virtual clinical trial as COVID-19 spreads aggressively
On April 2, 2020, the Food and Drug Administration issued the FDA Guidelines for Conducting Clinical Trials on 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 and quell participants’ fears (provoking hesitant participation).
Pre-pandemic many patients did not know about telemedicine, but with the passing of the CARES law, telemedicine technology is now at the forefront. With the use of virtual visits and remote monitoring, real-time vital data such as blood pressure, pulse/ox and blood glucose can be recorded by the patient or caregiver at home. Phone interviews are also recommended. One of the questions asked by sites attempting a seamless continuum in their process is how does the participant get the administration of the experimental treatment? It comes down to involving the patient in the process through self-administration, making it extremely urgent that patients who remain in the study demonstrate compliance.
Reducing the risk of clinical trials with technology
Not only is exposure risk mitigation addressed with virtual clinical trials, but also the process unleashes the power trapped in decentralizing studies. If the virtualization of a study is done properly, research teams will find that not only will engagement return, but there will likely be a surge. Running trials pretty much opens up the geographic area requirements to participants as well.
A successful virtual clinical trial should include (but not limited to):
Electronic consent that is compliant while recorded remotely
Remote visits via telemedicine
External sites should have the ability to upload source documents so that teams can check the external data
COVID-19 pharmaceutical trials
The COVID-19 pandemic and subsequent aggressive spread in the United States has ramped up clinical trials of drugs to prevent the virus from multiplying to vaccinations to alternatives to ventilators.
Pharma’s response until the increase in the number of confirmed cases and subsequent deaths is evolving every day. Pharmaceutical giants like Pfizer are testing existing medicines before treatment. The drug Xeljanz is under R&D for repurposing to fight COVID-19, along with a possible vaccine. Fujifilm is testing their existing candidate Avigan as a treatment.
Free resources available to support virtual trials
On March 31, 2020, Cleveland-based Saas provider Datatrak announced that they waive the license fees for their Datatrak Enterprise Cloud EDC software for all COVID-19 trials after recognizing the opportunity and responsibility they have to materially impact the fight against the virus. Datatrak ensures that all researchers working to contribute to vaccinations and effective treatments have free access to their platform to facilitate virtual teams and the collaboration and conduct of their clinical trials related to the novel coronavirus.
Maryland-based Advarra announced on March 26, 2020 that they: providing free research compliance resources. The initiative supports the clinical research community so that ongoing research can be conducted safely during the current spread of COVID-19. The resources offered include:
Free Transferred IRB Supervision
Access to the updated Forte eRegulatory administration tool
eReg Lite
access to “Ask Advarra” for efficient guidance on issues arising from the COVID-19 crisis.
Fighting united
With the aggressive communication of COVID-19, all aspects of medicine and life science are coming together with engineers and medical device manufacturers to be on the front lines to fight this virus and protect the lives of those who have contracted it and reduce the number of confirmed cases. .
Heidi West is a medical writer for Vohra Wound Physicians, a national group of wound physicians. She writes about care and technology in the medical industry.
