By Ashley Herrick and Nicole Carswell, Premier Research
Patient recruitment comprises one of the most significant initial challenges in any oncology study, but engaging and retaining patients throughout the trial can prove to be the challenge requiring the most up-front planning and coordination. However, during the initial planning stages of clinical trial implementation, the intensity of focus is usually placed predominately on speedy recruitment and not on patient engagement efforts, undermining retention rates and potentially negatively impacting the patient experience, thereby reducing the possibility of each patient’s participation in future clinical trials.
If a study must replace patients, it adds expense for the sponsor as well as timeline delays. Many modern clinical trials, particularly in oncology, also include a long-term follow-up element. Oncology trial endpoints are sometimes required to track patients for years to record side effects or the impact of future treatments, in addition to overall long-term survival rates. A patient who isn't adequately engaged will not complete follow-up long term — if they even stay throughout the treatment portion of the study. Consequently, the sponsor’s submission goals could suffer because they don't have adequate data, necessitating the enrollment of more patients or an additional trial. Therefore, implementing plans for patient retention for the duration of the study — and beyond — is vital, and considerations must be made during protocol planning to maintain acceptable retention rates.