THE EMERGING ROLE OF PATIENT-REPORTED OUTCOMES (PROS) IN CLINICAL TRIALS IN INDIA

Author(s)

BN V1, Naidu M2, Esam H2, Badgujar L2, Kinra G2, Dang A2
1Velammal Medical College Hospital and Research Institute, Madurai, India, 2MarksMan Healthcare Solutions LLP (HEOR and RWE Consulting), Navi Mumbai, India

Despite the average Indian patient becoming more knowledgeable with regards to his/her health, disease and treatment options, many Indian physicians still depend heavily on disease-related outcome measures to take health-care related decisions, and give minimal importance to patient-reported outcomes (PROs) pertaining to the effect of the healthcare interventions on the patient’s well-being. This trend is also seen in clinical trials (CTs) in India where PROs, if used, are only secondary to disease-related outcomes. As on today, there are no commendable patient-centered outcome researches (PCORs) happening in India. With the arrival of PCOR Institute (PCORI) in the US, PROs are now getting the attention that they deserve; however, in India the concept is yet to catch up. PROs have a significant role in CTs, such as determination of patient eligibility, determination of patient compliance, as a study endpoint, determination of health-related quality of life (HRQoL), and assessing economic burden and indirect impact of disease and treatment. Implementation of regular PROs assessment in clinical trials can help in determining the negative effects of therapy, comparing two standard therapies having similar survival outcomes, finding out whether a new therapy is preferable to standard therapy, determining whether a therapeutic regimen is better than supportive care only, when survival time is short, and making the communication easier in clinical practice. Improved design and proper implementation of PROs in clinical trials (CTs) are necessary to provide high quality evidence to synthesize clinical practice guidelines. Implementation of PROs in CTs should be made mandatory for pharmaceutical companies to prove their label claims, especially in a country like India where the generic market is strong and widespread. Also, data obtained from PROs in CTs should be made the source document for making health-related decisions at all levels in India.

Conference/Value in Health Info

2015-05, ISPOR 2015, Philadelphia, PA, USA

Value in Health, Vol. 18, No. 3 (May 2015)

Code

PHP186

Topic

Health Policy & Regulatory

Disease

Multiple Diseases

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