Asha Hareendran, PhD, Senior Research Leader, Patient-Centered Research - Evidera

Asha Hareendran

PhD, Senior Research Leader, Patient-Centered Research

A psychologist with more than 20 years’ experience in health outcomes research, Asha has extensive experience in qualitative and quantitative research methods, incorporating clinical outcome assessments in drug and device development programs. She has developed and validated many clinical outcome assessments (COA), including two instruments now included in International Clinical Guideline documents, and has worked on COA instruments for use in clinical trials in adults and children in cardiovascular, dermatology, mental health, neurology, rare diseases, rheumatology, urology and respiratory conditions. She has engaged with U.S. and European regulatory agencies to discuss novel instruments for the collection of data for inclusion on label claims.

Prior to joining Evidera, Asha worked in outcomes research for Pfizer, and was responsible for providing strategic direction and implementing outcomes research activities in various therapeutic areas, especially obtaining labeling claims based on COAs. She developed white papers and playbooks for incorporating COAs in clinical trials and developed standard operating procedures for linguistic adaptation of instruments. She actively contributed to initiatives to raise the profile of and standards for the measurement of patient-reported outcomes (PROs) in health outcomes research in the pharmaceutical industry, including the Cochrane Collaboration Quality of Life Methods Working Group, the European Regulatory Issues in Quality of Life Research, ISPOR PRO Translations Task Force, the FDA PRO – Harmonization Group and the ISPOR task forces related to linguistic adaptation of PRO instruments. She also led the first European cross-pharmaceutical industry consortium for the development of a PRO tool as part of the Innovative Medicines Initiative of the European Federation of Pharmaceutical Industry Associations and European Commission. Asha has also served as a part-time lecturer at the Universities of Kent and Canterbury, teaching the MSc course in surgical practice.

After obtaining a degree in psychology, human physiology and statistics, Asha completed four years of postgraduate training in social work in medical and psychiatric settings and completed her PhD in “Quality of Life Research in Cardiovascular Diseases” at the National Medical and Mental Health Institutes in India. Asha regularly presents workshops and participates in panel discussions at international conferences regarding methodological issues related to COAs. Her work has been published in numerous publications including Stroke, Urology, Journal of Wound Care, Clinical Drug Investigation, HQLO, International Journal of COPD, Journal of Rheumatology, Respiratory Medicine and Value in Health. She has also co-authored a chapter on the measurement of dyspnea in clinical trials in a book on dyspnea mechanisms, measurement and management.