Please login to the form below

Will COVID-19 necessitate a change in thinking around clinical trials?

The global outbreak of coronavirus (COVID-19) and current misinformation infiltrating our consciousness on social media has been a challenge to get our heads around, but it’s undeniable that there’s a public health risk currently proposed by the pandemic. With Italy in lockdown and other countries possibly following suit, will this outbreak impact ongoing clinical studies and those currently enrolling patients?

At the time of writing, it’s unknown how coronavirus spreads from person to person. It’s possible it spreads in cough droplets, like similar viruses. If an individual is advised to self-isolate, whether due to contracting the virus, or coming into contact with someone who has the virus, this will likely have a knock-on effect on clinical studies. People who are currently participating in clinical trials will be unable to attend appointments, and potential participants will be unable to be screened and more hesitant about joining.

The challenge with any clinical study is that every site visit is dictated by the protocol, which has been EC/IRB approved. However, there are options to improve participation that account for the current pandemic:

  • Increase opportunities to part by decentralising: introduce home visits or facilitate assessments through technology platforms
  • Partner with pharmacies and local health settings, who could assist with procedures such as blood tests
  • Post the investigative therapy directly to participants’ homes

These solutions are quick fixes that can ease the burden on healthcare and ensure clinical studies progress without disruption, but any protocol changes will need to be reported for EC/IRB approvals. For instance, the FDA regulations state:

“Each IRB must follow written procedures for ensuring prompt reporting to the IRB of proposed changes in a research activity, and ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects.”

Considering coronavirus is an immediate threat to the safety of people, it is grounds to make the appropriate changes to the study. IRBs should be notified as soon as possible to ensure changes are documented. If you have questions, please contact your local IRB representative and they should be able to help.

The coronavirus has raised some interesting points: why aren’t more studies partially decentralised? Why are pharmacies not able to do blood tests? Why is the investigational drug not shipped to the participant?

The clinical research industry should take learnings from this epidemic, have a period of introspection and work on improving the experience of sites and participants.

This blog was first published here: https://www.couchhealth.co/post/will-covid-19-have-a-short-term-impact-on-clinical-studies

14th March 2020

Share

Tags

Company Details

COUCH Health

+44 (0) 330 995 0656

Contact Website

Address:
Suite 2.10, Jactin House
24 Hood Street
Manchester
M4 6WX
United Kingdom

Latest content on this profile

The importance of health literacy in patient recruitment materials
Have you ever read something that instantly made you want to read on? Or have you begun to read something, and eventually given up because it didn’t resonate with you? This is where the importance of copy and headings in advertising comes into play.
COUCH Health
INFOSHEET 04: Create websites that recruit and retain patients, and engage and inform HCPs
We can guide you strategically and creatively to develop clinical study websites that engage, inform and enhance experiences for patients and HCPS, and in turn improve enrolment for your clinical study through increased referrals.
COUCH Health
INFOSHEET 03: Specialist study and site support for better patient recruitment
Our targeted outreach delivers highly qualified patients with a higher chance of converting to randomised study participants
COUCH Health
The importance of colour psychology on patient recruitment materials
At COUCH Health, we recently conducted a research project in collaboration with Lancaster University, exploring the impact of five key variables (copy, concept, colour psychology, headings and patient centricity) on the effectiveness of clinical study recruitment materials. Results to be released shortly. However, as a teaser we thought we’d create a mini blog-series – not only to showcase the results we found, but to emphasise why these variables are so important to consider when developing recruitment materials.
COUCH Health
How patient experience mapping can improve patient recruitment
It’s becoming more and more important to find new ways to increase recruitment and retention in clinical studies, and ultimately improve the patient experience. With the average cost to recruit and retain one patient being around $7,600 and the loss in revenue (due to delays) being an estimated $40m per month, it’s no surprise that pharma and biotech companies want to be more patient-centric and improve the clinical study experience.
COUCH Health
INFOSHEET 02: Improving diversity in your patient recruitment strategy
As inclusion and diversity advocates, we design and implement recruitment strategies that break down participant barriers.
COUCH Health