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Patients Driving the Clinical Trial Designs – Democracy in Clinical Research


Payal Bhardwaj*, Jeba Kumar and Raj Kumar Yadav   Pages 1 - 10 ( 10 )


Background: Many of the clinical trials remain inefficient owing to low retention rate, and an impact on the power of the study. In addition, regulatory bodies are recommending including the patient experience, especially, patient-reported outcomes, while making the 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 trial. Patients are now becoming 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, and achieve a near-real democracy, where clinical research is the by the patient, for the patient and of the patient.


Clinical trial designs, improved retention and successful trials, patient centricity, patient experiences and expectations


Tata Consultancy Services, Noida, Pfizer Pharmaceuticals, Chennai, Department of Physiology, All India Institute of Medical Sciences, New Delhi

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