Title:Patients Driving the Clinical Trial Designs – Democracy in Clinical Research
Volume: 14
Issue: 4
Author(s): Payal Bhardwaj*, Jeba Kumar and Raj Kumar Yadav
Affiliation:
- Tata Consultancy Services, Noida, UP,India
Keywords:
Clinical trial designs, improved retention and successful trials, patient centricity, patient experiences and expectations,
retention rate, FDA and EMA.
Abstract:
Background: Many of the clinical trials remain inefficient owing to the low retention rate,
and an impact on the power of the study. In addition, regulatory bodies recommend including the patients’
experience, especially, patient-reported outcomes, while making clinical decisions, and approvals.
Introduction: Patient centricity has reached the stage where patients are both willing and required to
participate in clinical trial designs, regulatory review and experts on other panels. Efforts are being
made in the right direction and there are multiple aspects that have been or are being addressed.
Objective: The current article focuses on how to include patients in clinical trial designs, the benefits,
challenges, and solutions. This means patients who were merely the participants until now, they will
be the drivers of trials now, and hence the clinical trials will be more efficient and productive.
Key Findings: There is a drive to enhance patients’ participation in clinical trial designs, especially,
visits, efficacy outcomes and their expectations with the treatment. Patients want to remain informed,
right from before participation to the completion of the trial. Patients are now an important part of
regulatory review, as apparent from recent initiatives by the FDA and EMA. This will enhance patients’
awareness, and bring ownership and transparency. Various patient organizations, advocacy
groups have made some great suggestions and taken initiatives in this direction. Clinical Trials
Transformation Initiative, European Patient’s Academy on Therapeutic Innovation, and Patient-
Centered Outcomes Research Institute are a few key initiatives. However, there is a set of challenges
emanating from the complexity of trials, associated with unique mechanism of action of drugs, their
efficacy and safety profiles, which has to be dealt with properly.
Conclusion: Overall, the pharma domain is at the verge of putting the patient in the spotlight, to
achieve a near-real democracy, where the clinical research is the by the patient, for the patient, and,
of the patient.
