Using Tech to align Regulatory and Market Access Evidence strategies
Traditionally, the teams responsible for clinical development and regulatory submissions do not consult the market access team until the end of the trial. In such a scenario, sponsors can run the risk of misaligned or insufficient evidence to achieve success as the evidence thresholds for regulatory bodies can often differ from those of market-access gatekeepers. For regulatory bodies, more weightage is given to the safety and efficacy of the new products, whereas for reimbursement organizations, greater attention is paid to how a new therapy compares to the most current standard of care with respect to the patient impact and costs to health care systems. This assessment of value also differs from country to country as what is considered as the standard of care varies depending on each country’s health care requirements.
This implies, a drug passed by the regulatory can still fail to reach the patients who need it because the trial was not planned to assure the reimbursement criteria and requirements were met.
Forecasting applications that take into account the dynamic market landscape, can be vital to help you align your clinical strategy for both regulatory and market access requirements. Innovative technology platforms such as, Cytel’s LiveSLR and Solara enable clinical development teams to assess the up-to-date scientific evidence by indication, and then utilize that evidence into methodically examining each relevant trial design, run thousands of simulations, and come up with the optimal design for their specific drug.
LiveSLR, created by an intelligent human-machine partnership, offers a systematic and comprehensive database of the highest quality global research that is always up-to-date, and can be easily accessed through a user friendly interactive, online platform. It provides real-time identification and review of all published medical literature that is fast, specific, and wholly relevant to your product, whenever you need it.
While LiveSLR helps you to stay on top of the evidence, Solara − a trial strategy platform − can use the comparator data that you get from LiveSLR to run different applications and generate an expansive range of models for development teams to consider. Millions of simulations run with Solara’s powerful design engines and enable sponsor teams to identify optimal endpoint selection, number and times for interim looks, Pareto-optimized tradeoff calculations, and more features to align design and clinical trial performance characteristics with a sponsor team’s clinical strategy.
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About the Author of Blog:
Mansha Sachdev specializes in content creation and knowledge management. She holds an MBA degree and has 11 years of experience in handling various facets of marketing, across industries. At Cytel, Mansha is a Content Marketing Manager and is responsible for producing informative content that is related to the pharmaceutical and medical devices industries.