Assessment of Knowledge, Attitude, and Practices on Genetic Research Data Reuse for Future Research: Clinical Trial Investigators Perspectives

Abstract

ABSTRACT Introduction: According to the principle of good clinical practice, it is imperative that the personnel involved in the pharmaceutical or genetic research possess an educational background and comprehensive training. The clinical trial investigator must ensure the safeguard the privacy and confidentiality and prevent inadvertent reuse of research results of study participants. Aim: The objective of the current research is to assess the knowledge, attitude, and practices of clinical trial investigators concerning the reuse of genetic research data. Settings and Design: As a cross-sectional study, there was only one-time collection of knowledge, attitude, and practice on genetics and its data for future research from clinical trial investigators from the Tertiary Care Hospital and Clinical Research Centers in Belagavi Karnataka, India. Subjects and Methods: A study was conducted using validated knowledge, attitude, and practices questionnaire on the clinical trial investigators. Statistical Analysis Used: Data were analyzed using the SPSS software version 21one-way analysis of variance. Results: The present study was comprised n = 50 clinical trial investigators calculated by using the general formula for the calculation of sample size with a confidence of interval limit, of whom 64% exhibited awareness of genetic data reuse in clinical trials. Seventy-four percent of clinical trial investigators expressed concerns about confidentiality issues related to the reuse of genomic data. Conclusions: The lack of synchronized international conference on harmonization of technical requirements for pharmaceuticals for human use (ICH) guidelines directives concerning genomic sampling and data management in health-care research presents a formidable obstacle for pharmaceutical sponsors in achieving consistent and standardized genomic research samples and its data execution in pharmaceutical research on a global scale.