CLINICAL TRIALS
PATIENT-CENTRIC CLINICAL TRIALS
How language and tech are re-shaping clinical trials today? This article elaborates upon the meaning of ‘patientcentricity’, and touches upon industry trends, evolving regulations and organisational strategies to develop a ‘Patient Focused Drug Development’ strategy, and the best practices and metrics used to define success. While technology has clearly been a game-changer in enabling a ‘patient-centric’ approach, with trials shifting focus from the site to the patient’s home, the industry is grappling with the need to ensure the ‘patient-connect’. This article discusses different strategies for driving patient-centric clinical trials, including the importance of listening to the patients needs and engaging with the patient in the right way.. Nimita Limaye, SVP, Strategic Partnerships and Medical Writing, CSOFT Health Sciences
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o, we’re spending US$2.6 billion on bringing a new drug to the market (FDA News, 2014) and we’re spending about a dozen years to do so. That is a lot of time and money spent! For whom are we doing all this, again? The patient, yes, of course! But are we really listening to the patient’s voice and addressing the patient’s needs? The right to self-determination is the consequence of a free society. Yet is the patient a passive recipient of healthcare decisions made by the investigator and the sponsor, or can patients be active participants and participate in the decision-making process and improve their own clinical outcomes? A report published by The
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P H A RM A F O C U S A S I A
ISSUE 40 - 2020
Economist Intelligence Unit (commissioned by PAREXEL) demonstrated that the patient-centric approach resulted in not only doubling the number of patients being recruited, but recruitment took half the time. In addition, the drug was 19 per cent more likely to be launched in these trials. Surprisingly enough, only 5.2 per cent of phase II-III trials followed this approach (EIU, 2018). The industry is waking up, albeit a little late, to the need to drive patientcentric clinical trials. The ‘Chief Patient Officer’ is a new term that has come into existence as the industry adapts to the ever-evolving model of clinical trials and pharma companies are now taking
measures to engage actively with patients. Bristol-Myers Squibb, for example, is soliciting patient inputs on their protocols, that include, among other things, the inclusion and exclusion criteria; and Ipsen Biopharmaceuticals seeks patient’s inputs from the start of the clinical trial set up and has adapted protocols based on patient’s inputs (Round and Williams, 2018). Merck has attempted to enhance patient retention by having at-home sample collection kits to minimise the patient burden. It is conducting conversations with subject matter experts to enhance its cultural competency and develop outreach tools. It is also monitoring enrolment data by ethnicity to enhance patient diversity and has focused on enhancing minority and ethnic representation (African Americans, for example, represent less than 5 percent of the clinical trial population) (Nissen and Geday, 2019). With a similar objective in mind, Janssen conducted trials like GRACE (Gender, Race and Clinical Experience) and LOTUS, using social media, imagery and educational materials, and arranged for transport and chose sites so as to optimise inclusion. In addition to recruitment, patient retention is of prime importance. With one-third of patients dropping out of clinical trials, companies are investing in diverse initiatives to enhance patient retention. Janssen Pharmaceuticals has gathered feed-
