In recent years, patient-centric initiatives are becoming key factors among healthcare companies, as they are increasingly becoming aware of the fact that the key to growing business and improving customer health is to better focus on the needs and concerns of the patient, rather than attending to just the product approval. The objective behind patient-centric drug development and other associated initiatives is to involve patients and the healthcare community as partners in order to bring about a sense of ownership in the success of new medical treatments. (1,2) There are four core principles that frame the growing arsenal of patient centric initiatives: (3)
- Relevance: Unmet medical needs identified in collaboration with and based on input from patients and their healthcare support network
- Pragmatism: Agendas and clinical trial designs recognised and accommodated in real-life patient and healthcare community needs and experiences
- Feasibility: The burden of study participation minimised and supported by initiatives that improve convenience
- Interactivity/Participation: Patient’s voice responded with the support from patient community, and giving the patient community an opportunity to be actively involved throughout the research process by amplified planning and execution
Adherence to the above principles facilitate patient-centric drug development to encourage the sharing of important information and drug development risk among a broader community of external partners e.g., academic and basic research groups, co-development sponsors, development operations alliances, and patient advocacy groups. (3)
A growing number of researchers are adapting to patient-centric initiatives across multiple studies, which can eventually be used while centrally monitoring and coordinating activities. This can further promote harmonization and can also better assist in communicating lessons learned from earlier implementations and from peer companies. Such activities can also help in deriving consensus metrics to evaluate the impact of various initiatives on organizational and study-level processes and performance. (3,4)
Return on investment (ROI) expectations are required to consider a reasonably long-term view. This is because researchers need enough time to collect experience with patient-centric initiatives, learn from mistakes while continuously processing their use. Ideally, target measures from multiple representative studies should be gathered two to three years prior to and after the implementation of initiatives. Stakeholders use some key implementation and ROI metrics to measure three broad areas, viz. reach; patient/study volunteer feedback; and performance. (3)
- Reach measures (e.g., number of pilot initiatives, number of planned initiatives, etc.) are usually quantitative, having an aim to assess the extent of adoption and usage within organisations, along with the number of patients and study volunteers who have participated in a given initiative.
- Patient/study volunteer feedback measures (such as ratings, etc.) are more often qualitative in nature; however, several organisations do implement a few quantitative feedback measures as well. Qualitative measures examine the subjective reports of satisfaction; sense of involvement in a given study or in association with a specific initiative, and the perceived relevance of specific clinical trials; while quantitative measures determine efficiency of patient/study volunteer participation in facilitating change. (3,4)
- Performance measures (viz. screen failure rates, number of procedures per visit or protocol amendments, etc.) are quantitative and they largely compare studies, whether or not they include the usage of patient-centric initiatives or not. (3)
We feel that it is too early to conclude on this aspect, as there is inadequate data demonstrating the extent and impact of patient-centric initiatives, across the industry. Needless to mention that patient-centricity movement is certainly inspiring the drug development enterprise to challenge and transform the traditional drug development prototype by putting the patient at its core.
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- Lopez Kunz B. Trial Return On Engagement: Quantifying Benefits Of Patient-Centric Initiatives. Clinical leader. June, 2017.
- A patient-centric approach: Patient-centric initiatives in drug development. March, 2017.
- Getz KA. ROI for patient-centric drug development. Applied Clinical Trials. August, 2015.
- Gets K. The transformative promise of patient centric R&D. May, 2015.
- Markowitz FE. Involvement in mental health self-help groups and recovery. Health sociology review : the journal of the Health Section of the Australian Sociological Association 2015; 24(2):199-212.