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ScientificTracks Abstracts-Workshop: J Clin Trials
Having a clinical study design which optimizes patient enrollment, site selection and clinical trial budget is one of the biggest
challenges for bio-pharmaceutical R&D industry. Since the first trials of legumes in biblical times to the first randomized
controlled trial of Streptomycin in 1946, clinical study designs are always aimed to answer a specific scientific question. The
increasing clinical trial cost and cycle time in the life science sector has indicated that just answering a specific scientific question
is not enough. It is necessary for the clinical study design to focus on potential downstream trial execution activities, patient
enrollment and to prevent costly protocol amendments. In order to address these issues we need to combine the clinical study
designs process with technology and leverage data. The clinical design software solutions integrate real world patient, cost and
investigator data to perform clinical modelling and simulations. The real world modelling produces “what-if scenarios” which
helps in analyzing cycle time, cost and risk tradeoff in present and future. Based on the clinical performance data and their
internal algorithms, these tools can perform “tiering” of country and investigator sites in alternatives such as best, average and
least optimum. They also ensure precise linkages occur between objectives, endpoints and procedures in the protocol. Predictive
analytics and real world modelling design tools would help the clinical development teams to take data driven informed decisions.
These tools will optimize patient enrollment and site selection, prototype multiple scenarios, reduce protocol amendments and
help mitigate risk in study development.
Anvita Karara is a Life Science Professional with expertise in Clinical Trial Design and modeling. She pursued her Masters in Biotechnology and Management from
Carnegie Mellon University, USA. She has worked prior in this space with leading bio-pharmaceutical companies such as Genentech (a Roche company) and Onyx
Pharmaceutical (an Amgen subsidiary).