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Overview: Pharmacovigilance and Risk Management

Drug development is an expensive, lengthy, and high-risk business taking 1015 years and is associated with a high attrition rate. Approximately only 1 in 10 drugs that start the clinical phase will make it to the market. Research on a new medicine does not end when the discovery and development phases are completed, and the medicine is available to patients. Tahseen Khan and Tanveer Khan at LabCorp Drug Development overview the details to consider in Pharmacovigilance and Risk Management.


‘Overview: Pharmacovigilance and Risk Management’

The issue is that industry in many instances is still approaching trials in the same way as practiced for the past twenty years with the expectation that the new communication technologies, digital health technology tools, and operational processes will fit into the same mould and follow the same timelines as a traditional trial with in-person visits to traditional sites. For instance, some sponsors utilise certain remote participant assessment instruments supported by technology such as electronic Patient Reported Outcomes (ePROs) as an add-on instead of building it into the initial protocol design as part of the trial strategy and data architecture. DCT components, such as digital health technologies (i.e., wearable devices), communication technologies (i.e., telehealth visits via videoconference) and/ or in[1]home clinical services (i.e., home health nursing services), are not being added until the later stages of protocol development thereby creating challenges to operationalising the final protocol and impacting overall feasibility. By not having a cohesive DCT strategy that considers the wider perspective of trial endpoints, participant journey, data architecture that is fit-for-purpose, and regulatory requirements across multiple jurisdictions, trial inefficiencies will continue occurring such as trial delays due to enrolment and retention issues and inefficient use of DCT components. Persistent inefficiencies may be observed at the participant, research site staff and sponsor level unless changes occur to adopt DCT principles as customised solutions.

For our industry to transform to DCTs there is a need for new methodologies that incorporate protocol development, enable the customisation of individual trials and an acknowledgement that over time traditional trial activities, framework and roles will be changed or replaced.

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