OBJECTIVES: To conduct a TLR to assess the impact of implementing patient-centric approaches and personalized clinical trials on enhancing patient engagement in drug development.

METHODS: Relevant studies published in the last 10 years were identified by searching Embase (via OvidSP) on 28/02/2023 using predefined search strategies. Additionally, hand searches were conducted on selected websites and Google Scholar.

RESULTS: Of 3,309 abstracts retrieved, 98 publications were included in the qualitative synthesis and 24 were chosen to answer the objective. Patient engagement is a collaborative partnership with individuals, families, and communities at all stages of the research process. It is increasingly common to involve patients in the steering committees of trials, either as representatives or research collaborators.

Considering patients as collaborators rather than passive recipients developed in context of patients increased education, knowledge, and interest; enhanced communication among patients; and well-structured patients’ organizations. Both pharmaceutical industry and FDA endorse this collaboration to facilitate drug development. Finally, guidelines have been developed to promote patient involvement.

This social transformation represents a crucial factor for the development of “personalized clinical trials” (PCTs), which recognize patients as primary stakeholder in drug development. Key elements of PCTs include: (i) considering patients as partner and recognizing their unique role and knowledge; (ii) involving them in trial design and outcomes selection; (iii) utilizing electronic data capture systems to reduce the participation’s burden; (iv) conducting on-going surveys to gather their personal opinion; (v) providing support to patients during adverse events; (vi) implementing robust communication processes; and (vii) involving patients in the diffusion of trial results.

CONCLUSIONS: In the past decade, clinical drug development has experienced a social transformation regarding involving patients as active participants throughout various phases of the trial. The development of personalized clinical trials holds immense potential for improving patient recruitment and retention in clinical trials.