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Showing posts with the label Clinical trial management systems

The Roles of the Core Study Team in Clinical Trials

Conducting a clinical trial involves much more than just a physician and a patient. The skills of many experts are required in the design and running of a clinical trial. Such skills include; trial coordination, data processing, regulatory management, medical research, and many more. The people who play these roles are vital components in successfully initiating and conducting a clinical trial 1 . A successful clinical trial is a product of different personnel, all working together on various tasks at the same time to ensure everything comes together. Matching individuals with appropriate tasks ensures the proper use of the program’s resources and that the team members enjoy and remain challenged by their roles. 2 Some of the roles of the core team members involved in clinical trials will be discussed below. Principal Investigator (PI) The principal investigator is the lead personnel at the clinical trial site and oversees the conduct of the clinical trial. The PI is most times ...

Factors Affecting Physicians Referring Patients to Clinical Trials

Introduction It has long been recognized that a very low number of patients are referred into clinical trials. According to estimates, only 2–3% of patients are referred for trials, a low number. Poor accrual is a threat to the timely completion of increasingly large studies, which are very important considering the criticalness of properly evaluating the latest treatments, while also avoiding the potential for random error associated with small studies. Referral for a clinical trial is not simple as it can be quite difficult with numerous steps to be taken in order to become a part of the process, such as: •         Patients need to be identified •         The study concept must be introduced •         The positive and negatives of experimental therapy must all be outlined •         The risks and benefits of standard treatment als...