title: Application of critical path analysis in clinical trials.
abstract: Clinical research operates in a strictly regulated environment under various management models, but a distinct management model of clinical trial (CT) still needs exploration and research. Critical path analysis (CPA) is a management approach can be used for monitoring, analysis, and prediction of success of its time-bound operational activities. A model CT was compiled with 78 activities, which were further merged into 35 major activities. After performing dependence analysis, the list was finalized with 25 activities which were taken in activity predecessor to create a network diagram and perform CPA considering patients, conduct, and outcome. Activities were inclusive, described the trial entirely with accuracy, and were in chronological and logical sequences. This approach does not replace an understanding of or adherence to the requirements contained in all applicable regulations, guidelines or standard operating procedures governing clinical studies but ensures the proper use of operational and decisional approaches including optimal resource management. As the need to meet deadlines becomes more important and the need to produce good, stable project plans, CPA is very useful for determining activities that can lead to project delay. With this approach, project may be effectively monitored, and realistic schedules can be maintained.
authors.affiliation: Department of Pharmacology, Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India.
authors.forename: Amal
authors.initials: A
authors.lastname: Kumar
authors.affiliation: Clinical Research Organization, R and D Core Committee, Cadila Pharmaceuticals Limited, Ahmedabad, Gujarat, India.
authors.forename: Bhaswat S
authors.initials: BS
authors.lastname: Chakraborty
keywords: Clinical trial operation; critical path analysis in clinical trial; decision model in clinical trial