Patient compliance in clinical trials – the elephant in the room

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May 1, 2022

Clinical trials cost a fortune. When a patient is non-compliant during the run-in/washout period, he/she is dropped out of the study. This costs the sponsor 5X: site costs for 2 patients, recruitment costs for 2 patients and loss of time.

In other words, retention is more important than recruitment. This raises the question: why is the focus of decentralized trials on recruitment and not on patient retention?

Patient compliance is a $495BN problem in clinical practice (see references 1 and 2 below). There are a plethora of companies working on patient adherence in clinical practice.

But – is anyone connecting the dots between lessons learned on patient adherence in clinical trials with patient adherence in real life clinical practice?

1. Viswanathan M, Golin CE, Jones CD, et al. Interventions to improve adherence to self-administered medications for chronic diseases in the United States: a systematic review. Ann Intern Med. 2012;157(11):785-95.

2. Watanabe JH, Mcinnis T, Hirsch JD. Cost of prescription drug-related morbidity and mortality. Ann Pharmacother. 2018;1060028018765159. doi: 10.1177/1060028018765159. 

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