The COVID-19 pandemic is disrupting clinical research worldwide as enrolment in active clinical trials has been severely affected. Since early March several clinical trials have been halted or delayed accordingly with clinicaltrials.gov due to COVID-19 spread. In order to mitigate operational challenges and ensure patient safety, investigators reported adopting or planning to adopt technology-based interventions.
Major challenges of COVID-19 in clinical research
- Redirection of clinical research resources from other therapeutic areas to COVID-19
- Delayed or cancelled patients visits
- Protocol deviations
- Unresolved queries – incomplete patient data
- Clinical staff safety
- Administration of investigational drugs
Introduced innovations during COVID-19 in clinical research
- Adoption of technology-based interventions
- Reduction of on-site monitoring visits
- Reduction of in-person patient visits
- Use of telemedicine
- Remote electronic medical record access for monitors
- Virtual monitoring of data and study documentation
- Home-based testing
- Curbside or courier pick-up and delivery of participant samples and investigational products
- Provision of study updates to participants — by telephone, email and through the electronic health record portal
- In-person visits under strict enforcement of clinical protocols for viral infection prevention and the use of PPE
- Screening for COVID-19 symptoms, fever and potential exposure
- Masks and physical distancing requirement for all in-person interactions
All of these are positive changes that we will retain long after the COVID-19 pandemic subsides. Looking to the future, the possibility that the COVID-19 pandemic could have an enduring impact on clinical research and the practice of medicine in the future, with technological solutions such as telemedicine being adopted with increasing frequency even after the crisis. The current implemented innovations demonstrate the resilience of clinical research community and their commitment to continuously serve their patients, by continuously developing new drugs.
