Assessing Views on Using Surplus Human Bio Specimens for Future Research among Pharmaceutical Sponsors: A Prospective Interventional Study

Background: Pharmaceutical sponsors have a significant responsibility in gathering and overseeing the storage of leftover human biological samples. Understanding the proper utilization and potential risks associated with these stored specimens is crucial for pharmaceutical sponsors. Educating these sponsors on biological sample research is imperative. Hence, the present study aims to assess, evaluate the Knowledge, Attitude and Practice (KAP) among pharmaceutical sponsors in relation to the utilization of surplus human biological samples for future research. Materials and Methods: A study was conducted in which pharmaceutical sponsors participated in both pre- and post-intervention assessments to evaluate prospective changes. Prior to the survey, self-prepared and validated Knowledge, Attitudes and Practices (KAP) questionnaires were distributed among the sponsors, uncovering certain gaps in their knowledge, attitudes and practices. Following this, health education was administered through oral sessions and leaflets. A follow-up survey was conducted one month later using the identical set of questionnaires to assess any changes in KAP among the pharmaceutical sponsors. Results: A research recruited 52 participants from pharmaceutical sponsors, with men greater than women by 75 percent. Most of participants (69.2%) were between the ages of 20 and 30, with 73.1% having a pharmacy background. In addition, 82.7% had between 1-5 years of work experience. Senior Clinical Research Associates (CRAs) accounted for 30.8% of participation, while CRAs made for 23.1%. The research project begins with a pre-test to assess participants' knowledge, attitude and practices, followed by an educational intervention and a post-survey one month later. The McNemar-Bowker test revealed significant improvements in scores (p-value<0.005) after the intervention. Conclusion: Educating pharmaceutical sponsors about leftover bio specimens reduces misuse as well as helps in understanding the ethical issues involving leftover bio specimen studies.