Open AccessDevelopment and Writing of Clinical Trial Protocol
Author(s) -
Supriya Nikam,
Akash Inde,
Anjali Jambhulkar,
Abhilasha Ghule
Publication year - 2022
Publication title -
international journal of pharmaceutical sciences review and research
Language(s) - English
Resource type - Journals
ISSN - 0976-044X
DOI - 10.47583/ijpsrr.2022.v72i01.011
Subject(s) - protocol (science) , clinical trial , reliability (semiconductor) , task (project management) , medical physics , medicine , randomized controlled trial , alternative medicine , medical education , pathology , engineering , power (physics) , physics , systems engineering , quantum mechanics
The protocol of clinical trial serves as the study planning, conduct, reporting and appraisal. Writing a research proposal is one of themost challenging and difficult task as research is a new area for the majority of postgraduates and new researchers. In the field ofmedicines in order to ensure better understanding of human biology and improve their health standards, conducting the clinical trialsremain a key approach. In general all randomized clinical trials require a protocol to explain rationale, method adopted, measures toensure the safety of study subjects, about research funders and organizational details right from the beginning of trial till reportingof the final results. Multiple discrepancies have been observed in clinical trials, and all of them have to be addressed to make clinicalresearch safe for humans. In conclusion, the development of comprehensive protocol not only provides a mechanism to ensure the monitoring of trial but also safeguards the study subjects and increases the reliability of trial results.