Best Practices for Managing Clinical Trials During and Beyond the COVID-19 Pandemic

Industries Profiled:
Medical Device; Biotech; Biopharmaceutical; Clinical Research; Pharmaceutical; Health Care; Computer Software; Telecommunications; Laboratories


Companies Profiled:
Alcon; Alnylam Pharmaceuticals; Aptus Clinical; Atara Biotherapeutics; Cipla; CSL Behring; Cytiva; Idorsia; Kyowa Kirin; MedinCell; Merck; Novartis; Ora; Inc.; Sanofi; United BioSource

Study Snapshot

Best Practices, LLC engaged 18 leaders from 15 life science organizations in this research through a benchmarking survey. More than half of the research participants serve at the director or executive level.

Key topics covered in this report include:

• Impact of COVID-19 Pandemic on Clinical Trials
• Virtual Clinical Trials
• Clinical Trial Data Collection
• Benefits of Virtual Clinical Trials
• Staffing Changes During the Pandemic
• Key Learnings on Managing Trials During the Pandemic

• Delay in Clinical Trials: Many companies have delayed clinical trials by 3 to 6 months. About 2 in 10 trials have halted completely.

• Enrolment: Companies are enrolling patients through registration links sent over email and video calls. Some companies have also built an app to improve patient enrolment.

Sr. No.	Topic	Slide No.
I.	Overview	p. 3
	Universe of Learning	p. 4
	Key Insights on Managing Clinical Trials During COVID-19 Pandemic	p. 5
II.	Impact on Clinical Trials	p. 7
III.	Virtual Clinical Trials	p. 10
IV.	Data Collection	p. 16
V.	Benefits of Virtual Clinical Trials	p. 19
VI.	Staffing during the Pandemic	p. 22
VII.	Key Learnings	p. 25
VIII.	Participant Demographics	p. 27
IX.	About Best Practices, LLC	p. 30

• Impact on timeline of clinical trials due to the additional safety protocols and monitoring processes to be followed; anticipated duration of delay in clinical trial activities
• Financial impact on organizations due to the delay/halt in clinical trials

• Executive narratives around virtual trials and telemedicine
• Switch to remote assessment of the patients involved in a clinical trial since COVID-19; Percentages of trials possible under remote assessment of clinical patients with data monitoring and additional safety protocols
• Process followed to enroll patients virtually
• Challenges faced by clinical trial teams in enrolling new participants in this current situation
• Change in existing patient population dropout rate due to COVID-19

• Changes made in clinical trials protocols to prevent COVID related obstacles in the gathering of clinical data; Gaps in data gathering in virtual trials because of limited / no access to the medical facility / trial site
• Effectiveness of the steps taken to ensure accuracy and validity of the data collected remotely during COVID-19

• Addressing pre-existing challenges faced during on-site clinical trials with the switch to virtual trials
• Benefits, if any, encountered while remotely conducting virtual clinical trials

• Changed in staffing levels at trial site since COVID -19;
• Changes implemented in access to ensure safety (of patients and staff) at clinical trial site (In-patient site and Out-patient site)

• Key learnings on managing the ongoing and new clinical trials during this COVID-19 pandemic