The COVID-19 pandemic has negatively impacted all facets of clinical trials including patients, sponsors, regulatory agencies, and central labs. Bioinsider recently hosted its virtual Friday Roundtable for a discussion on Challenges of Conducting Bioanalysis in Clinical Trials in the Midst of COVID-19. This discussion was moderated by Dr. Mohamed Hassanein, Associate Director, Clinical Assay Lead, Pfizer and Dr. Michael Partridge, Associate Director, Bioanalytical Sciences, Regeneron Pharmaceuticals with participations from scientists representing various pharmaceutical companies conducting non-COVID-19 and COVID-19-related clinical trials, contract research organizations (CROs), and representation from the U.S. Food and Drug Administration (FDA).
The Roundtable identified several impacts due to COVID-19 on clinical trials including
- Clinical and logistical operations
- Resources and supply chain restrictions (e.g. Clinical supplies, drug, PPEs, limited bed capacity)
- Challenges to patient compliance (missing treatment or collection visits) and enrolment in clinical trials (illness, travel restrictions, other socioeconomic reasons). Vulnerable patient populations (e.g. oncology) are especially impacted.
- Opening of new clinical sites and or temporary closure of existing ones.
- Logistical disruptions/delays to sample collection, processing, and shipping from the sites to central labs and from central labs to bioanalytical labs
- Reduced workforce capacity at the bioanalytical labs and consequences on meeting internal, external, and regulatory timelines
- Resources and supply chain restrictions (e.g. lab reagents, consumables)
- The magnitude and nature of the negative impact on the industry may vary between large and small pharma/biotech/CRO organizations.
- In the near-term, big organizations may be able to cope with the logistical challenges such as supply chain disruptions and reagent shortages while smaller biotech/CROs are more profoundly impacted
- The long-term impact should the pandemic continues for an extended period is yet to be determined. The participants agreed that if current processes continue or if subsequent waves of COVID-19 occur, sample collection, shipment, and analysis workflows are not apt to sustain the successful conduct of clinical trials.
Identified Potential Solutions
- Adopt patient-centric sample collection approach (in-home collections)
- Embrace novel technologies to expedite and streamline sample collection (e.g. microsampling)
- Leverage exciting technologies such as multiplexing to maximize the utility of the limited number of available samples
- Onsite real-time analysis (for qualified clinical sites)
- Open, honest, and continual dialogue between sponsors and regulatory agencies to assess the potential impact of the pandemic on the submission timelines and evaluate the required data packages.
Open questions that still need further and immediate discussion
- Do we need to rethink the traditional workflows for sample collection (patient-centric), shipment and analysis?
- What are the regulatory expectations for Emergency Use Authorization (EUA) or Biologic Licence Application (BLA) during the pandemic especially for COVID-19 therapeutics?
- What is the FDA position on using non-validated pharmacokinetic assays and for determining adverse events (e.g. ADA) for EUA submission package for COVID-19 therapeutics?
- What if the sponsor does not have any ADA data because the assay is not ready due to tight timelines and or reagents are unavailable?
- Is banking samples and testing later acceptable for EUA? And similar questions apply for a BLA (although presumably with the assays a bit further along in terms of availability, extent of validation, etc.)?
- Are we prepared for the next wave or future pandemics?
Due to high demand, Bioinsider will provide a follow-up Friday Roundtable to discuss and find solutions to these open questions. If you missed the first one, make sure to sign up for the follow-up Friday Roundtable on this topic here.