Are your patients compliant, and is the data you’re collecting reliable? Are you going to need to enroll more patients due to uncertainty? If you’re conducting research, you might be encountering these questions right now. If you’re about to start a study, you should anticipate these questions.
Sponsors deal with myriad considerations in how to reduce overall risk and costs across a study, but managing the complexity of patient behavior must always stay in focus. Study teams have an imperative to ensure patients are well informed and prepared to participate in their own therapies.
The challenge of patient treatment adherence and retention can do a lot more than create delays and increase expenses during a clinical trial. When a patient does not comply with the treatment regimen, the integrity of the clinical trial data is at stake, and patient safety is at risk. Nonadherence can “lead to an underestimation of the efficacy of a treatment and dismissal of a potentially useful therapeutic agent.” If the research is on pain medication, and the patients are not adhering to the therapy, not only will the potential efficacy of their treatment be jeopardized, but there will be a downstream impact on how the patient reports pain to investigators, which results in bad data. Variances in data quality reduce the statistical power of the sample size, which results in enrolling more patients and delaying clinical trial completion timelines.