The current pandemic situation highlights a weakness in our traditional approach to clinical trials. You are probably experiencing some form of lock-down (“stay at home order” by your local or national government). Our innate sense of optimism says this crisis will blow over fast, but there are also dark clouds suggesting weeks may turn to months and true return to normality will take longer than we dare to think.
The health care system may now be focusing all its resources on managing the impact of COVID-19 to the expense of your trial. Study enrollment and execution may be paused, delayed, elongated as a side effect of the “stay at home” guidance. At worst, volunteers (research participants) undergoing longitudinal assessments will be lost, new patients will not be enrolled, and product shelf-life gets shorter for each day. These factors threaten the typical clinical research activities associated with recruiting participants and conducting clinic visits.
"Nutrasource has an on-site phase 1 unit dedicated to supporting Nutrasource studies. This can be a fast track for your study to be planned and performed at the same site in a seamless transition from planning to performance."
There is hope - Time to get creative
There are creative approaches for your clincal trial that can save the day.
To keep your study on track, strive for these goals: 1) reduce or remove the burden of work from the clinical trial site, and 2) prevent the need for travel or close volunteer-medic interaction.
Each study needs tailoring to its specific demands, but some general help rules can apply:
- Communicate with your Institutional or Ethics Review Board and provide a plan for Protocol Deviation
- Implement an electronic patient consent system
When recruiting new participants, Informed consent can be performed electronically (with IRB approval, many valid systems are in place for this). Nutrasource has performed trials in the United States and globally where subjects have received information and consented without entering a physical clinical research site. In other countries we also see the use of user-friendly, secure methods for providing informed consent.
- Use eCRFs that the participant can complete
- Consider a site-free study
- Consider using a visiting phlebotomist, self-assessments, self sampling.
With the use of electronic case report forms (eCRF’s) and other study related documents and an internet savvy public, data can be entered by the participant themselves. You can also consider that participants can monitor their own compliance, report adverse events, and perform qualitative self-assessments. Although not all studies are able to take advantage of these features, it is worth examining how your trial can be adapted as technology and creativity can push the borders of traditional study design.
The participant´s responsibility can be further extended to sample collection, for example in a probiotic study, participants can collect and post faecal samples. If a suitable blood sample collection procedure is available (e.g., finger prick) then self-testing may be an option, otherwise a licensed phlebotomist can be used for home visits if this falls within regulations.
Learn from others
These examples are highly dependent on the nature of the study, but many nutritional, non-IND studies are suited to these alternative methods. Nutrasource has performed and published such a study in which blood sampling, patient consent and patient data were all performed remotely. There was no clinical site, and the study PI was the Nutrasource in-house medic.
Plan for the future
Finally, we also need to plan for normalization. When that day comes, enjoy your “release” party, sleep off the aftermath, and be ready to start activities as quickly as possible. These weeks do not represent dead-time, use them to fine tune your study design, identify sites, obtain IEC/IRC approval, and obtain import/export licences. Our optimism often underestimates the time needed to lay foundations for studies, so use the time we have available now. Nutrasource has an on-site phase 1 unit dedicated to supporting Nutrasource studies. This can be a fast track for your study to be planned and performed at the same site in a seamless transition from planning to performance.
If you wish to explore alternatives for your clinical study design contact Nutrasource today. We have always been dedicated to providing innovative and high quality scientific solutions for our clients in the nutracuetical and pharmaceutical industries.
Derek Tobin, P.hD.
Director of Business Development, Europe