In the following blog, Jeff Trotter, Senior Vice President, Worldwide Evidence, discusses the impact of COVID-19 on observational research, and recommendations on how to proceed in the current climate.
Notwithstanding the horrific human toll, the COVID-19 pandemic is certainly affecting the conduct of both traditional clinical trials and observational studies. And, not surprisingly, our customers already undertaking or considering an observational study/registry have asked for our guidance on determining the impact of COVID-19 on their research initiatives. Informed in part by frequently updated FDA guidance documents, discussions with IRBs/ECs, and both internal and external medical, epidemiological, and other professionals, our recommendations are as follows:
First, reaffirm the strategic and scientific imperative underlying any particular observational research initiative striving to compile real-world data and potential evidence of clinical, economic, and/or humanistic value, and/or safety data from actual practice situations. Because real-world patients are still being managed by their real-world personal physicians, spotlighting the practice of medicine in this unprecedented period will offer important insights. Life will go on after the pandemic abates, and the rationale for conducting observational research will continue to be important, if not more so.
Second, post-pandemic, there will undoubtedly be a new normal; indeed, perhaps new standards of care reflecting the impact of healthcare systems adopting telemedicine processes as routine. As observational studies seek to document treatments and outcomes under “normal” conditions, we fully expect there to be an increased need to better understand these new standards of care in and of themselves and as baselines against which to examine the impact of new drugs and devices.
Third, consider incorporating the following methodological and operational shifts in current and planned studies:
- Documenting virtual patient encounters (versus in-person visits).
- Recognizing that there may be dramatically different visit patterns and interactions with physicians that may affect treatment approaches and the resulting outcomes, notwithstanding the impact of COVID-19 itself on patients in observational studies. Build in some flexibility to your data collection forms to accommodate rapidly evolving treatment paradigms.
- Considering different approaches to key measures and assessments. For example, in some cases, a patient-reported outcome questionnaire intended for self- or clinician-administration at a visit can be implemented electronically and online. In other cases, however, this may be impractical or methodologically invalid.
- Altering site management and data quality assessment processes. Our observational research processes have always incorporated trigger-based on-site visits and remote data review approaches, so this shouldn’t be all that much of a shift.
Fourth, analytically, we are already planning for new levels of analyses that accommodate subtle and not-so-subtle shifts in treatments and outcomes pre-, peri-, and post-pandemic. In most cases, these rely on supplemental data collection that can be easily accommodated.
Last, but certainly not least, we understand the priority currently being placed on COVID-19 and related research into vaccines and treatments. As sites participating in observational studies are on the “front line” of patient management, the pandemic is certainly impacting the regular operations of and staff resources supporting healthcare practitioners and day-to-day medical practice. As a key goal in operationalizing observational studies and registries has always been to be as unobtrusive as possible, communicate with sites to ensure you have an understanding of their new normal and adjust your approaches to help them work through these difficult times.
What do you think about my recommendations on continuity in observational research? What else should be included to maintain momentum in progressing the industry forward?
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