As the principal investigator (PI) for ObvioHealth, a digital clinical research organization (CRO), I can describe first-hand the challenges of meeting the enrollment goals of a clinical trial while maintaining patient engagement throughout. Reducing drop-outs (post-enrollment discontinuation of the participants) is a critical component of any successful study, as lost data points can lead to the need for further recruitment (requiring additional time/resources). In this article, I will provide an example of a clinical trial our team has conducted while utilizing a digital hybrid model (minimizing site visits/maximizing the use of virtual site). We met the dropout allowance in this trial by preserving patient engagement.
Before delving into the metaphorical antidote for dropouts, let�s diagnose the main problem areas that contribute to patient withdrawal in the traditional setting:
Our team recently completed a clinical trial tasked with measuring the efficacy of a dietary supplement as an intervention for adults with an elevated blood pressure, or stage I hypertension. Study protocol required the enrollment of 128 patients and established a 25% dropout allowance at a statistical power of 85%, confirming the number of participants needed to achieve the study endpoints. By employing a hybrid study model, sustaining patient engagement, and reducing resources required of the patient and study team, we successfully beat the dropout allowance.The following breakdown details the steps taken to reduce dropout during each stage of post-enrollment:
At last, an uncomplicated formula consisting of only two variables: real-time interaction with the study team and inclusion of a hybrid study model. This pairing allows for the study to become available at the finger-tips of the patient from the comfort of their home. We�ve designed ClaimIt� to make this concept a reality, ultimately reducing the burden placed on the patient, and in turn, limiting dropouts.
Written by Parth Shah, M.D., Medical DirectorParth is a physician scientist with diverse clinical and research experience. He is an expert in cardio-metabolic and endocrine diseases and is passionate about improving patient care via advancements in research. Dr. Shah serves as an investigator in sponsored and investigator initiated studies. He has great experience in all phases of clinical trials from planning and development to its execution. Dr. Shah is skilled at providing medical input to cross functional teams such as clinical operations, IT, business development, biostatistics, pharmacovigilance, etc.Dr. Shah has published many manuscripts in credible, peer-reviewed medical journals and presented research at prestigious medical conferences.He earned a Bachelor of Science from Youngstown State University, Doctor of Medicine from Washington University of Health and Science, and served as a clinical fellow/researcher at Mercy Health/Jewish Hospital.