During the COVID-19 pandemic, scientists, physicians, and public health epidemiologists have come together, and there has been a surge in research worldwide. Basic science research has been leading the way in developing vaccines and genome sequencing the SARS-CoV-2 strains. The industry has ramped up research on developing antibody tests and viral tests to keep up with the increased need for COVID-19 testing. Clinical research and trials have drastically increased to investigate the efficacy of various treatment methods, including convalescent plasma, monoclonal antibodies, drugs such as remdesivir, and now vaccines. And lastly, public health epidemiology research has been crucial in understanding and improving the prevention, transmission, and mitigation of the virus.
Most individuals in the general public do not understand the complex process involved with research, let alone how much more complicated it becomes during a pandemic. During the pandemic, researchers are faced with the challenge of condensing what normally takes years, down to a matter of weeks. Researchers have to design and conduct studies with methodological validity and produce reliable and safe tests and treatments – all in shortened timeframes.
1. Expediting research while maintaining human subject protections is a constant challenge.
Institutional Review Boards (IRBs) exist to protect the rights and welfare of human subjects involved in research, ensuring studies meet strict ethical and regulatory requirements regarding fair enrollment, informed consent, safety of study participants, data privacy, and the minimization of risk. During the pandemic, however, this review process has been strained due to the vast increase in the number of studies requiring review and approval prior to enrolling participants. In addition to the increase in studies to review, IRBs have been trying to expedite the review of new research protocols to allow studies to begin enrollment.
Clinical trials often have strict enrollment criteria, which can slow down enrollment and limit generalizability. During a pandemic, however, rapid data collection and results that can be generalized to everyone, especially the minority populations, is important. Furthermore, with the current research in vaccines, the idea of “challenge studies” has been controversial, where a healthy individual is given a COVID-19 vaccine and then intentionally exposed to the SARS-CoV-2.
2. This delicate balance between expediting research while maintaining methodological validity and peer review standards can lead to error.
Study designs may be flawed, and confounding variables may be overlooked. Research regulations may be overlooked, and oversight committees may expedite review processes at the expense of quality and safety. The peer-review process, which is in place to improve scientific quality and validity, has also been sometimes overlooked with the rapid review many journals have for COVID-19 studies.
3. Science is a dynamic process.
Science is a process – questions are generated, hypotheses are made, interventions are tested, data is collected and analyzed, and conclusions are drawn. Based on the results of one study, further questions arise, which lead to the process repeating itself. To improve scientific validity, multiple trials evaluating the same interventions are essential. Systematic reviews and meta-analyses combining multiple trials together can then be conducted to better evaluate the efficacies of interventions. Relying on any one study leads to misinformation and diversion of resources from the development and evaluation of potentially more promising therapeutic interventions, which jeopardizes patient safety and lives. For example, an initial study reported on the potential effectiveness of hydroxychloroquine as a treatment for COVID-19. Further studies, however, have challenged this. Antibody testing has presented numerous challenges and problems, especially with validation and interpretation of tests, with many having their emergency use authorizations (EUA) revoked after further review of data.
Expediting the research process while maintaining human subjects protection and ensuring scientific validity and integrity is a delicate balance during a pandemic. We must remain cognizant of the fact that science is a dynamic process and constantly changing. Maintaining awareness of each study’s limitations will help us judge the data and help guide clinical judgment and practice.
Christine Lau is a physician.
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