COVID-19 and geriatric clinical trials research.

The SARS-CoV-2 pandemic has wrought tremendous upheaval to daily life, spreading rapidly and causing millions to contract COVID-19. The long-term effects are yet unknown, but scientists are studying the disease and searching for solutions. In geriatric clinical trials research, the problems presented by COVID-19 are multifaceted: older adults face increased risk of morbidity and mortality due to COVID-19, and so ongoing clinical trials that enroll geriatric participants have been disrupted, appropriately so, in light of these increased risks [1]. Yet, the interruption of ongoing trials may further increase risks to older adults as critical research on treatments for highly prevalent diseases and conditions is slowed or stopped. Further, older adults are substantially underrepresented in clinical trials research, and this situation may worsen this discrepancy. Scientists in aging appreciate the necessity of older adults’ inclusion within clinical trials, but the vulnerability to increased exclusion in clinical trials of this population is high, now more than ever. Attention to clinical trial development with special attention to need for inclusion of older adults and precautions is greatly needed to sustain current efforts, at minimum, and ideally, enhance recognition of the value of including older adults in clinical trial research. The COVID-19 crisis affects every aspect of clinical trial research engagement including: recruitment and retention; ability to ensure participant safety while engaged in experimental interventions; study procedures, including consideration of remote assessments, impact on populations with health disparities, and generalizability of future results; outcome measures, including biomarker assessment; impact on the clinical trial workforce, including attrition; impact on dissemination of results and scientific collaborations, which move the clinical trial infrastructure forward; current and future funding allocations; and regulatory considerations in regards to management of altered study conduct and change of outcome measures (Fig. 1). COVID-19 pandemic and other disasters impact every aspect of clinical trial engagement, conduct and outcomes The purpose of this article is to highlight the impact of disasters such as the COVID-19 pandemic on geriatric clinical trials research and propose approaches for the scientific community to continue pushing forward. Disruptions due to disaster can often result in disruptions to study protocols, challenges to data interpretation, the need for Institutional Review Board (IRB) amendments, and the introduction of new biases [2]. Prior research highlights the importance of proactive plans to minimize study disruption, the need to adapt rapidly to changing constraints, and the importance of ongoing communication with contract research organizations and sponsors and to share and develop strategies to mitigate participant-related protocol deviations and violations. Application of these actions should all occur in the context of local conditions. Researchers have not previously seen this global level of disruption to clinical trials. Effects of COVID-19 on geriatric clinical trials research will be long-lasting. Trials in their enrollment phase will at a minimum be delayed in achieving full recruitment, leading to lags in, or losses of, discovery. Depending on the duration of stay-at-home orders, some studies may be permanently disrupted and discontinued. For more established trials, if attrition leads to final sample sizes much smaller than those required by the a priori power estimates, then these ongoing studies may not have enough statistical power to identify positive findings. Trials that involve in-person cognitive assessment face challenges as they move to other modalities for testing, which may influence results. Efforts to validate existing measures through remote assessment should continue, to enable meaningful cognitive measures to be assessed remotely. In addition, investment in low cost technology to support these efforts, for participants who may not have remote access, may enable studies to continue with limited disruption, while also ensuring those of lower socioeconomic status are not left behind. Clinical trials involving those with cognitive impairment face unique challenges during such crises [1]. These individuals depend on routine for optimal functioning, as well as access to health care, and supportive community engagement. At a time of social distancing, routines and support systems are dramatically altered. Social cohesion and community can offer protections and resiliency for older adults during the time of disaster management. Maintaining and supporting active participant and recruitment engagement is essential. For example, the addition of virtual connection, training, and additional contact may prove highly beneficial. Efforts to maintain engagement will need to be complemented by efforts to evaluate safety and efficacy. Many of the existing safety and efficacy measures within current trials are coming to a halt or being offered through non-traditional means, with unknown validity. Individuals continuing to take experimental medications may continue to have check-in safety calls but may have delays in bloodwork and imaging scans that would otherwise provide reassurance regarding any potential adverse medication effects. For infusion studies, medication delivery may be halted, but lingering effects of existing dosages are still possible. Careful evaluation of potential drug effects and critical safety measures will optimize the likelihood that safety is not compromised. Behavioral studies have additional challenges due to the prolonged proximity of participants and researchers required in some intervention. While the impact of abrupt halting of these trials is yet to be known, maintaining vigilance while planning to resume is essential. There is need for attention to implement gradual,...