How to move to virtual clinical trials during Covid-19 (Part 3)

Part 1 | Part 2
  • Engage with participants

Far from creating a sense of remoteness, virtual trials can prevent patients from feeling isolated by creating more timely and personalized touchpoints. Fortunately, existing technologies have paved the way to more engaging interactions with patients and assessment of their overall health and safety. When going virtual, ensure all participants know what they need to do, when, and for how long. Make sure participants understand why their contribution is key and how they are helping make an impact.

Throughout the pandemic, it is crucial to keep patients and caregivers up to date on the study status. You can send regular updates via e-mail, use social media for engagement or video calls to stay in touch. The coronavirus spread is a unique opportunity for people to see how research around Covid-19 is rapidly advancing and how efficiently it can provide the much-needed treatment, which in turn will help them be more open to research in the future.

  • Ensure high dose of design thinking

As noted by Bruce Hellman, CEO of uMotif, “running virtual trials requires an even higher level of design thinking. It’s critical to ensure patients truly understand the aims of the research, how they are making an impact, and what they need to do. When running a site-based study with in-person training and onboarding we can rely to some extent on the HCP to impart this information. However, in a virtual trial there is a heightened need for clarity of messaging and simplicity of technology”. 

  • Address possible adherence issues in advance

Adherence issues can affect virtual trials just as much as site-based trials. Virtual trials have the potential to improve the overall adherence among patients for more than 90% if the following points are addressed in advance:

  • Provide simple and easy to use technology
  • Send regular updates on study progress, so they understand that their data is making an impact
  • Make it clear among patients which research questions they are helping to answer 
  • Don’t try to do it alone – collaboration is key

The job of conducting trials in the midst of this pandemic is at an extremely high degree of difficulty. And, as the pandemic and the shutdowns drag on, the difficulty in conducting trials will only increase. Even if companies can add virtual elements to trials and incorporate more digital technologies to track patients, that doesn’t mean most sponsors can do so, or have the needed expertise to make it happen.

Now, more than ever, sponsors need to know where to look for the help they need. Consultants, technology providers, CROs or even competitors unite their know-how and expertise in these difficult times. With professionals available to help you with these projects, now is a good time to reach out to them for guidance. The expertise is out there. Don’t hesitate to call on it and be open to collaborating.

Conclusion

Clinical trials have largely followed the same model for more than 70 years now. This is why the global Covid-19 pandemic has the potential to open the door to another side of conducting research. Virtual trials are the answer for many types of research, and we need to see adoption increase. There is a high chance that the life science industry will go back to normal once the pandemic is over. 

However, there will already be enough data and experience to compare performance of traditional and virtual approaches, learn the lessons and apply the best parts of them in the future design of clinical trials. In the drive for more virtual trials, we must never forget the vital role that human interaction plays in the delivery of healthcare and research. Our human touch is key and will be even more important following the current crisis.

Sources:

https://www.europeanpharmaceuticalreview.com/article/116456/covid-19-update-running-clinical-trials-during-the-coronavirus-pandemic/

https://hub.jhu.edu/research-human-subject-research-phase-two-contingency-plan/

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf

https://pharmaphorum.com/r-d/views-analysis-r-d/virtual-trials-take-centre-stage-during-covid-19/