Investigators’ Insight into the Utilization, Adaptation, and Challenges of Patient-Reported Outcomes as a tool in Clinical Research in India

Study Title:  Investigators’ Insight into the Utilization, Adaptation, and Challenges of Patient-Reported Outcomes as a Tool in Clinical Research in India

Patient-reported outcomes (PROs) have become increasingly important in clinical trials as they incorporate valuable insights into the patient experience, symptoms, and overall quality of life. PROs encompass data directly reported by patients regarding their health condition without interpretation by healthcare professionals or anyone else. These measures can include symptoms, physical functioning, emotional well-being, and overall health-related quality of life. However, there are challenges associated with the use of PROs in clinical research. By understanding the challenges faced by investigators in using PROs, investigators can improve the patient experience within clinical research, leading to more patient-centric research practices. Hence, this present study aims to understand the challenges encountered by the investigators while using PROs in Clinical research.  The survey will be conducted among the Investigators belonging to Medical colleges and Research Institutes across India. Potential participants will be identified through the Clinical Trial Registry of India website. “Patient-reported outcomes” “Electronic diary and “ediary” or “e-diary” will be used as keywords to search the trials which have Patient Reported Outcomes.  Then the list of  Principal Investigators [PIs] in that Clinical research will be prepared in Excel along with their contact details [email and mobile phones].  The questionnaire will be administered using a Google form. The link to the Google form will be sent via WhatsApp or email to Principal Investigators. Participation in this survey will be anonymous and all identification data will be kept confidential.