Efforts were made to define patient centricity from the perspective of a patient [3,6]. For patients and patient organisations medical education and communication using plain language, co-creation (e.g. the dialogue of researchers with patients, patient input in trial design such as end point selection, etc.), easy access to medicines and related information as well as transparency regarding clinical trial data were defined as important principles of patient centricity [3,6].
The engagement of patients in the development of new therapies has been recognised as a valuable strategy, and an increasing number of pharmaceutical companies are implementing patient-centred activities . Involving patients throughout the entire development process, i.e. throughout the lifecycle of a product, holds the potential to provide key information and valuable insights from patients. Understanding of the disease and its impact on patients’ daily lives, identifying unmet medical needs, considerations related to clinical trial design, selection of clinically meaningful endpoints, and requirements regarding e.g. drug formulation are key points of patient-centric approaches . The importance of patient input into drug development has also been recognised by regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The ICH E8 (R1) Guideline “General Considerations for Clinical Trials” that came into effect on 14 April 2022 has set patient-focused drug development as a key priority. It strongly encourages the involvement of patients and patient organisations at all stages of drug development, as it “is likely to increase trust in the trial, facilitate recruitment, and promote adherence” . This is supported by the ICH Good Clinical Practice E6 (R3) Draft Guideline that recognises the input of patient in trial design as important factor to ensure quality and meaningful trial outcomes .
Anticipated benefits for the pharmaceutical industry are facilitating successful and efficient patient recruitment and enrolment while minimising drop-out rates and thereby accelerating clinical trials [4,8]. Furthermore, an early identification of patient relevant outcomes and the input by patients in trial design may lead to an overall improvement of study quality. In turn, patient-centric activities have the potential to save costs, as poor recruitment and retention, as well as failure to adequately address patients’ needs during early development, can have costly long-term consequences for a product’s success throughout the clinical and post-authorisation stages .