BayBiotech.NET In a clinical study, patient focus is central to the success and a patient centric study design and considerations can not be undermined. From start-up phase to maintenance until a study close-out, successful patient enrollment within timelines recruiting right population, safety and efficacy of the patients is a key sponsor and regulatory consideration. Any lapse in care, could cause millions for a sponsor in terms of credibility. Those who have remained engaged in clinical study management have seen repeatedly, how important it is to keep patient advocacy groups engaged every step of the way to accommodate patient voice in the key study design. Patient Advocacy groups play a pivotal role representing the patient populations with certain conditions and support both a study sponsor contributing to the success of the study as well as could play a role in design optimizations to ensure patient voice is heard to meet the needs. Found a great read on 'Understanding role ...
BayBiotech.NET Decentralized clinical trials should account for adequate processes for reporting medication errors and safety events...A well-organized plan must include training of participating HCPs on following study protocol processes for the reporting of adverse events. Not only should HCPs be made aware of the contact details of the study personnel, but participants should also be informed so they can reach out for medical assistance. A lot of these responsibilities to prepare the logistical details fall on the study sponsor; however, study Principal Investigators also remain responsible for working with local HCPs to monitor the clinical safety of the participants... Useful link: https://www.fda.gov/media/189263/download?attachment