Late Phase Research
REGISTRAT-MAPI has extensive experience and expertise in the design and conduct of Late Phase studies. Due to industry consolidation and globalization, Late Phase studies are increasingly being conducted as global programs. FDA’s (FDAAA/REMS) and EMEA’s (EU-RMP) increased focus and guidance for industry on post-marketing safety surveillance and risk minimization has resulted in a significant increase of risk management programs and mandated post-marketing requirement studies. Additionally, CMS and AHRQ are driving the use of evidence based medicine and comparative effectiveness research (CER) to enhance quality of care and make better informed reimbursement decisions.
Late Phase studies can direct future product development and manage risk. Biopharmaceutical and medical device manufacturers have begun to look at the product development lifecycle as a clinical development-commercialization continuum by evaluating risks during product development to proactively plan for risk mitigation activities upon product approval and thereafter. Furthermore, there is increased industry expenditure on approved products to manage safety risks and product utilization, demonstrate effectiveness, and support expanded use through new indications.
REGISTRAT-MAPI expects that the evolving industry environment will stimulate increased Late Phase research through implementation of various peri- and post-approval programs:
- FDA/EMEA-mandated studies to obtain pregnancy, pediatric, and other special population data, as well as additional safety, effectiveness, and long-term exposure information
- Increase in the number of global product/disease observational studies
- Comparative effectiveness trials
- Co-sponsorship of observational studies by biopharmaceutical companies that have products in a common therapeutic area or class
- Increased industry collaboration with regulatory agencies, NIH, CMS, and AHRQ to conduct post-approval studies
- Post-approval disease, product, and pregnancy registries to obtain effectiveness, safety, and humanistic data from patients in a real-world clinical setting
- Emphasis on health economics, outcomes, and PROs, with more information being obtained directly from patients (direct-to-patient)
- Pre-approval disease registries to support clinical development of a product
- Phase IIIb studies conducted as a “bridging” strategy between clinical development and commercialization of a product
- Open label clinical trials to expand product indications
- Switch/transfer studies
Late Phase programs play an integral role in biopharmaceutical and medical device manufacturers’ clinical, risk management, and commercialization efforts for products. These companies are seeking established and innovative partners like REGISTRAT-MAPI who have specific experience and expertise in the Late Phase arena to address regulatory and risk management considerations, integrate clinical development and commercialization efforts, build customer relationships with academic centers and new Investigators, create a clinically relevant and meaningful data repository, and provide credible disease and product-specific information from post-approval studies.