Development and Execution of In Vivo Bioassays
January 8, 2022
Patient Centricity in Clinical Studies
Shift in focus
The clinical research industry has come a long way from viewing patients as mere “subjects” to playing an integral part in the success of clinical trials. Pharmaceutical and biotechnology industries are consciously making changes in the conduct of clinical trials by designing patient-centric trials. With access to technology, many of the patients are well-informed making it important for sponsor companies to encourage quality patient-physician interactions even before enrollment into trial. This approach is a win-win situation for the Sponsor and patient with the patient made aware of the trial design and expected outcomes while the Sponsor finds cost-effective solutions even before patient enrollment.
Multi-dimensional approach to transparent communication
Sponsor companies are seen engaging in innovative ways of gathering patient feedback such as contests or competitions to gauge patients’ view on varied aspects of the trials, be it design, perceived effectiveness, patient needs, or even on different regulatory documents. For instance, patient feedback on informed consent forms (ICFs) can help simplify language so that the form easily conveys trial rules, procedures involved and/or the expected/unexpected risks of participation. By promoting open communication between companies, doctors, and patients using technology and social media platforms, the chances of patient retention and satisfaction are higher thereby leading to improved clinical outcomes. Encouraging hospitals and clinics to maintain centralized electronic medical records can also contribute to accurate, timely, and seamless storage of patient data. This in turn reduces errors in data handling with easier access to full patient history while conducting clinical trials. In addition, publishing clinical trial documents such as protocols and study reports on a centralized repository that are accessible to professionals and non-professionals implies the Sponsor’s efforts in promoting transparency and building trust with the public.
Patient engagement initiatives
Pharmaceutical industries, stakeholders, regulatory bodies, and healthcare providers understand the need to have a patient engagement model built on mutual trust, transparency, accountability, inclusiveness, and effective communication and partnership. Research studies are being carried out to examine the implementation of patient centric activities in contract research organizations and in pharmaceutical/biotechnology companies. These studies suggest that each company has its own way of implementing patient centricity with many factors influencing their decision such as organizational hierarchy, investment, and availability of resources.
Although patient engagement initiatives have gained momentum in the past decade, there is an urgent need to standardize these initiatives across pharmaceutical/biotechnological sectors and regulatory bodies to maintain ethical clinical practices as well as to measure performance using operational metrics.
Although patient engagement initiatives have gained momentum in the past decade, there is an urgent need to standardize these initiatives across pharmaceutical/biotechnological sectors and regulatory bodies to maintain ethical clinical practices as well as to measure performance using operational metrics.
Conclusion
Patient centricity is gaining prominence as access to healthcare increases. This inevitably puts the clinical research industry in spotlight to adapt and adopt technologies to build a mutually beneficial partnership. This helps in keeping a check on the quality and ethical aspects of the clinical trial with better research outcomes and healthcare as well as improved return on investments.
Sources
• Sharma NS. Patient centric approach for clinical trials: Current trend and new opportunities. Prespect Clin Res. 2015;6(3):134-138.
• Pushparajah DS. Making Patient Engagement a Reality. The Patient – Patient-Centered Outcomes Research. 2018 Feb;11(1):1-8.
• Yeoman G, Furlong P, Seres M et al. Defining patient centricity with patients for patients and caregivers: a collaborative endeavor. BMJ Innov. 2017 Apr;3(2):76-83.
• Lamberti MJ and Awatin J. Mapping the Landscape of Patient-centric Activities Within Clinical Research. Clinical Therapeutics. 2017 Nov;39(11):2196-2202
