MS 27.04 Approaches to Patient-Centric Clinical Trials: Sharing Challenges and Lessons Learned

Abstract

Patient-centricity means much more than episodic patient involvement in health care. A Patient-centric culture requires that patients play an active role in all health care subareas from identifying unmet needs, pre-clinical research, clinical research, drug authorization, drug reimbursement to drug prescription. This study focuses on patient-centricity in clinical trials. While in former days a patient participating in a clinical trial very often felt like a “laboratory mouse” only being instructed what to do and often without any understandable information nowadays those responsible for research and drug development discover the advantages of patient involvement such as better recruitment, patient friendly protocols, a better retention rate etc. Till now the main focus was effectiveness and safety of drugs to be shown by cost-intensive clinical trials. Nowadays value of treatments and relevance of outcomes to patients are of special interest. Patient Advocacy organizations help with recruitment by informing their members about new clinical trials. Crowdsourcing techniques addressing different communities like medical experts, patients and researchers are used to provide responses to survey questions. Apart from the arising enthusiasm about the doubtlessly potential opportunities the necessary requirements and their costs such as patient education costs, efforts to establish long-term partnership with patient advocacy groups, implementing patient advisory boards, legal framework conditions which protect patients but do not hinder their active participation as stakeholders etc. should not be underestimated. Additionally, pharmaceutical companies need to implement patient-centricity as a strategy across their functional departments. Successful patient-centric clinical trials require the willingness of patients especially of those who experienced clinical trials to provide their input in order to support improvement.