COVID-19 has affected all aspects of life and clinical trials are no exception. How have teams decentralized so quickly while keeping research on track? How have researchers incorporated regulatory changes and new guidance? We asked three industry professionals for their insight into strategies being used to manage workload and keep clinical research timely during this time of great uncertainty.
Bodo Lutz, Clinical Risk Management and Data Integrity QA, Novartis Global Development Quality
The sense is we weren’t as prepared as we all thought – how did your team decentralize so quickly while keeping research on track?
"Having performed decentralized trials prior to the COVID-19 pandemic we used this expertise and already contracted service providers to shift trials from traditional to (partly) remote operating model, successfully."
What regulatory changes/guidance have been released/adjusted globally and how are researchers incorporating them?
"As countries were impacted by COVID-19 with different severity and at different time periods, relevant health authorities published guidelines at different stages of COVID-19. Global trials needed to be adapted following country specific requirements.
Some of the guidelines have not considered all aspects of possible remote trial settings which could have been implemented by the Sponsors, for example, Home Nursing, to minimize a patient’s exposure to COVID-19 while continuing with patient treatment and ensuring patient safety.
The change of trial settings to a remote approach was linked to the need of each individual trial depending on, for example, the pandemic situation, risk assessment outcome, patient treatment, and patients’ health conditions."
What are some lessons learned from this process?
"We will work to be prepared for a potential second COVID-19 wave. Congresses like Clinical Trials Europe will enable Sponsors, Service Providers and Patient Advocacy Groups to share experiences, challenges and potential solutions."
Abby Sener, Manager, Almac ONE
What regulatory changes/guidance have been released/adjusted globally and how are researchers incorporating them?
"Both the MHRA and FDA released COVID guidance on documenting deviations to protocols and/or established procedures. Almac was able to leverage this guidance to inform our business strategies and solutions, as well as incorporate this when we were approached by various sponsors to assist with managing the impact of the pandemic on their ongoing and future trials. Many sponsors were (and are still) seeking alternative, sometimes unconventional, ways of supplying clinical material to patients due to either patient inability to travel or the site closures.
We closely examined the various Privacy Regulations and Standards and compared these to our contractual agreements to determine what solutions were possible to support from a system perspective. Now, we continue to see clients focusing on advanced planning for future impact from the pandemic, investigating options such as including direct to patient distribution into protocol design and study requirements up front."
Trellis Usher, Founder & CEO, Nova Health Labs
What has been implemented in your team that has been a huge success?
"Our team was used to working remotely when the pandemic hit but we weren’t very efficient at it. We could count on our in-person meetings to catch up. Post-COVID, we had to be very intentional about doing a few things to help keep us on track:
- Stood up a team collaboration site
- Clear accountability on roles and responsibilities
- Defined timeline for tasks and milestones
- Standing weekly update meetings with agenda
- Weekly “team office hours” where we were all available and could jump on a call or virtual meeting if needed (not Monday or Friday)
How can we think about conducting clinical trials during the time of COVID-19?
"Our software platform uses voice technology (think Alexa and Siri) and voicemails to triage practice communications. One of the things we are looking to explore but haven’t run a pilot on yet is how can this technology be used to help gather PRO for clinical trials. Our position is that our software can automate the collection of patient reported outcomes from patients participating in trials while offering them a frictionless experience:
- The trial participant will set up a profile on our mobile app. We can work with the trial sponsor to set them all up in a single batch so the patients don’t have to worry with that initial step.
- The trial participant gets a call from to authenticate their identity and confirm they are in a specific trial and phase.
- On a set frequency (daily, weekly, monthly), participant receives a call with pre-set questions and can answer them just as if they were having a phone conversation.
- Information and data are automatically transcribed, compiled and sent to trial manager or sponsor for analysis. Nova can also do some basic analysis.
Participants will then be reminded of site visit dates, times and locations via voicemail, email or text."