Clinical trials are the bedrock of clinical research, but the older adult population too often is excluded. Clinical trials are experiments that involve human patients or subjects. They are designed to assess the safety and efficacy of a medical treatment, which could be a medication, vaccine, device, procedure, or behavioral intervention (such as diet or exercise). Some clinical trials compare a new treatment to a standard treatment, or to a placebo, or to no intervention at all, while others compare two or more existing therapies or an existing therapy in a new population.
Typically, clinical research studies don't include large numbers of older adults. There are a variety of reasons for this: poor recruitment strategy, characteristics of older adults that make participation more difficult (e.g., comorbid illness, multiple medications), logistical challenges of conducting research in nursing home or long-term care facilities, and ethical concerns over the risk vs. benefit of participation, among others.
Clinical studies follow a specific research plan or protocol created by the trial investigators and designed to measure a specific outcome, while looking for adverse effects or other previously unknown findings. Because they are critically important for determining efficacy and effectiveness of new and existing therapies, it is important to include older adults in clinical research trials, as they may respond differently than the younger population typically studied.
Insight Therapeutics has a strong understanding of what makes appropriate research participants and how to manage the intricacies of clinical trial work in this complicated geriatric population. We help our clients determine appropriate recruiting, statistical methods, matching strategies, and Institutional Review Board issues related to clinical research that includes a wide variety of patient populations, including older adults in nursing homes, long-term care facilities, and in community care settings.