The entire journey of clinical trials from proof-of-concept (POC) to regulatory submission is the most expensive component of the research and development process. Clinical trials operate under strict environment and clinical trial management models need further research and exploration.
Critical Path Analysis (CPA) in Clinical Research
The activities, duration, and conditions of time-bound activities like assessment of safety or to predict safety concerns through evaluation of potential adverse effects of medicinal products; proof of concept and efficacy of large studies; post-marketing surveillance, pharmacovigilance and periodic safety update reports decide the fate of the clinical study. Critical Path Management is a method that uses predictive analytics to forecast and manage critical milestones. Clinical trial management tools like CPA (Clinical Path Analysis) optimize and improve clinical trials by every means possible. This service aggressively improves better transparency of data; mitigates potential risk, bottlenecks and delays; understands connections and dependencies between all milestones and activities; classifies the total inventory in the workflow; identifies areas to intensify resourcing and proactively managing all activities.
Critical path analysis is a management approach used to monitor, analyse and predict success of operational and time-bound activities.CPA becomes important and very useful in determining and preventing activities that can lead to project delay so as to meet deadlines and produce stable project plans. CPA allows trials to be realistic and effectively monitored as per desired schedules; improves drug development; reduces cost and uncertainty by application of scientific tools in clinical development process.
Pros and Cons of Critical Path Analysis (CPA)
Critical path analysis can be applied to manage resources and time duration of activity is experimentally or deterministically known for a given trial. The motivation of CPA towards overall management of a trial comes from the existence of many dependent, independent or parallel activities and uncertainties involved. CPA is a technique applying network strategy with the objective of systematic planning used for monitoring, scheduling and controlling complex and large projects. CPA formally achieves timely completion of the whole project by identifying tasks or activities that can be completed on time. It helps to recognise which project steps need to be accelerated to complete the project within the scheduled time. It also identifies the minimum time period required to complete a project along with missed or overrunning tasks which can be delayed in case resources are reallocated.
The disadvantage of Critical path analysis technique is that the project plans are communicated and managed against the relation of tasks to time which is not immediately obvious, making it more difficult to understand. It is not always possible to sort out or completely identify start and finish times of various activities. The design of an innovative clinical trial management approach developed for a project-specific operating plan during a study is an element subjective to time estimates. This management approach does not understand or adhere to the requirements contained in all applicable guidelines, regulation, or standard operating procedures governing these studies but ensures optimization of clinical trial design, analysis, management and cost.
Clinical Research Online Course at JLI
James Lind Institute (JLI) provides online programs – Post Graduate Diploma in Clinical Research or Professional Diploma in Clinical Trial Management (PDCTM)for better management of clinical trials. JLI also conducts online programs in pharmacovigilance, medical writing, clinical data management, regulatory affairs, quality assurance and pharmaceutical medicine.
For more information please visit: www.jliedu.com