Late Phase Research | HTA: Emphasizing the Need in HTA Evaluation

Presented by

Premier Research - Colleen Coleman, Associate Director, Program Strategy, RWLP & Diana Iammarino, Clinical Project Lead, RWLP

About this talk

Health technology assessments (HTAs) play a critical role in the creation of medical, public health, and social policies that help ensure the right patients have access to the right treatments at the right time and at the right cost. Outcomes from late-phase research are valuable in achieving positive HTA recommendations because they provide insight into not only the efficacy and safety of a drug, but also the patient’s needs, patient-relevant benefits, and economic perspectives related to that drug. For drug developers, understanding HTA and designing clinical trials and economic evaluations to support this assessment are essential to gaining market access and traction in an increasingly crowded landscape. This webinar will examine the linkage between late-phase clinical research and HTAs, emphasizing the growing need for carefully designed clinical studies and economic evaluations to support post-marketing success. Participate in this webinar to gain a better understanding of: The purpose of HTAs. Based on a multifaceted evaluation of clinical, economic, ethical, legal, and societal perspectives, HTAs are used to inform decision-making that promotes an equitable, efficient, and high-quality health system. The HTA evaluation process. Though the process may vary from region to region, there are common milestones shared by all HTA bodies. The continuum of evidence development necessary to support regulatory requirements and HTA evaluation. Parallel advice on evidence development may provide a better pathway from laboratory to market, and data from pragmatic trials may provide greater relevance for stakeholders. The patient’s role in HTA. Patient contributions are not limited to the outcomes collected and analyzed during a study. Patients may also be surveyed on their reimbursement experience, and their input is often sought in reviews of HTA recommendations. HTA in the real world. Case studies provide insight into the opportunities and challenges of HTAs.

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Premier Research is a clinical research company, dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors. Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.