Perspective of Researchers Towards Conducting Clinical Research

Good Clinical Practice (GCP) guidelines have been introduced in India more than one and a half decades ago. A limited number of agencies are providing training on GCP, with no standard curriculum followed resulting in different variations in the expected outcome.

The present survey was conducted to assess the attitude of researchers involved in clinical research and to recognise most important topics in GCP training to enhance clinical research.

An online-survey was conducted using Survey Monkey. More than 500 researchers were contacted through email. The questionnaire comprising 10 questions including demographic details and questions related to their perceptions and difficulties in conducting clinical research were sought.

A total of 158 participants responded to the survey. Female researchers were less as compared to male researchers. Complicated paperwork (39.2%) and the concept of lost-to-follow-up (39.2%) were the major issues for conducting good clinical research. In the workshop attended, statistical analysis (60.3%), sample size calculation (58.2%), data management (56.2%), how to write a protocol (53.4) and ethics (44.5%) were the most interesting topics for them. Participants indicated that most of the criticisms from reviewers were on sample size calculation and statistical analysis.

Our study results emphasize the need for training on topics of statistical analysis, sample size calculation, ethics, and writing of a protocol. GCP training in clinical research with biostatistics may improve the quality of research. Adequate formal training of GCP to all the investigators, managers and data management staff will help them to adhere to ethical requirements.