Plan Early for Late Phase Clinical Trials
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The late phase research environment has changed dramatically in recent years. Regulators in the US and abroad are demanding a more proactive approach to safety and risk management. In light of these changes, sponsors must begin working with their strategic research partners early in the investigative process to anticipate and plan for late phase studies.
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Plan Early for Late Phase Clinical Trials
- 2. FOCUSED. TRUSTED. GLOBAL. Drug Development Life Cycle MAA /NDA submitted Phase I Phase II/III Marketing Authorisation Phase IIIb Product Development Data to address: Long-term safety Quality of Life Cost-Effectiveness Phase IV Commercialization Maximize product potential
- 4. FOCUSED. TRUSTED. GLOBAL. Regulatory Framework Food and Drug Administration Amendments Act (FDAAA) o Pre FDAAA-Before 2007 Post-marketing studies or clinical trials to demonstrate clinical benefit for drugs approved under accelerated approval requirements Deferred Pediatric studies where required under the Pediatric Research Equity Act Studies of clinical trials to demonstrate safety and efficacy in humans to be conducted at the time of use of products approved under the Animal Efficacy Rule. o Post FDAAA Assess a known serious risk related to the use of the drug Assess signals of serious risk related to the drug Identify an unexpected serious risk when available data indicates the potential for a serious risk. Start early developing risk mitigation strategies
- 5. FOCUSED. TRUSTED. GLOBAL. Study types: Interventional/Observational o Randomized clinical trials o Observational epidemiologic studies o Expanded Access Programs o Post-Authorization Safety/Efficacy studies o Health Economics and Outcomes Research o Registries
- 6. FOCUSED. TRUSTED. GLOBAL. Key Objectives For Successful Commercialization o Long-term real-world safety data and risk management FDA/EMA mandated Adverse claims New endpoints, health outcomes, effectiveness o Maximize market penetration New comparators and dosage forms Label extension o Provide access to yet unregistered drugs EAP/Named Patient/Compassionate use studies o Build relationships with prescribers and payers Brand loyalty o Health economics and Patient Reported Outcomes Reimbursement
- 7. FOCUSED. TRUSTED. GLOBAL. Outsourcing for Efficiency o o o o o o Facilitate early planning Leverage previous learning Ensure process clarity Utilize innovative technologies Streamline project execution Maintain organizational focus The result? Saving
- 8. FOCUSED. TRUSTED. GLOBAL. Find the right team o Therapeutic expertise o Local knowledge and global reach o Operational efficiencies o Market access expertise o Greater flexibility
- 9. Summary o http://www.medpace.com/PDF/FactSheetLate_Phase_1_30_rev_2.pdf Medpace Late Phase Capabilities
Editor's Notes
- The late phase research environment has changed dramatically in recent years. Regulators in the US and abroad are demanding a more proactive approach to safety and risk management. (click) In light of these changes, sponsors must begin working with their strategic research partners early in the investigative process to anticipate and plan for late phase studies.
- Early planning for late phase should optimally begin well before the MAA/NDA is submitted. (Click) The early collection of data for long-term safety, quality of life, and compound efficacy is recommended – (click) to maximize product potential in the commercialization stage of the product.
- The regulatory landscape has changed over the past ten years with new regulations and study requirements. Mandates put into place in response to massive drug safety concerns and recalls make for a challenging environment. While the picture can be daunting, early consultation taking into consideration (click) required safety considerations, additional data requirements, and health economics, can make the path smooth.
- In the last few years, the industry has seen an increase in focus and guidance from the regulatory bodies on post-marketing safety surveillance and risk management. Compliance with these regulatory rules impacts the race to commercial success. (Click) Before 2007 mostlate phase studies were used strictly to demonstrate clinical benefit. (Click) In 2007 the FDA enacted a set of mandates to assess known safety signals associated with late phase drugs. These mandates have contributed to longer, more complex studies. In 2008 a similar set of mandates was adopted by the European Medicines Agency (EMA). (Click) Developing an early strategy for risk mitigation will enable companies to conduct late phase studies efficiently.
- Post marketing studies may take on different forms (Click) but the unique characteristics of both interventional and observational studies should be considered early on - as a basis for designing effective late phase studies.
- (Click) To be successful in the current marketplace, the product should have the long term real world safety and effectiveness data addressing questions from the regulators, payers and patients alike. (Click) Embedding post-marketing considerations into earlier phases facilitates further approval of label extensions and new dosage forms. (click) Although not contributing directly to marketing applications, expanded access programs serve an important role in improving access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who do not have comparable or satisfactory alternative therapies. (click) One key issue for developers is an attention to the many stakeholders involved regarding late phase considerations. (click) Building relationships with these groups helps to establish brand loyalty later on. (click) In turn, a greater understanding of the health economics of a product and its impact not only on clinical but also on economical and humanistic outcomes is critical for a clear pathway to reimbursement.
- Outsourcing with study partners drives study efficiency! Teams can start planning for late phase activity years before filing for registration. Embedding late phase considerations into the process before key trial protocols are established ensures optimal research design.(Click)Every study has a learning curve. Engaging a strategic partner at the beginning of the process and working with them throughout means the research team climbs the learning curve only once. What’s more, the team can integrate its growing body of knowledge into each successive phase of the research driving innovation. A long-term strategic relationship ensures consistent communication, process clarity, and research continuity translating to faster, more economical research. (Click) The result? (click)Saving of time and money.
- Selecting the right team to produce total quality is critical for long term success. Teams that offer, (click) therapeutic expertise, (click) local knowledge and global reach, (click) operational efficiencies,(click) market access and (click) expertise, and (click) greater flexibility will allow sponsors to maximize commercialization efforts.
- New approaches to Late Phase Research yield new views for research and development. (click) Multiple objectives arising from both R&D and Marketing influence the study design. Choosing a flexible, strategically focused CRO will deliver a Win-Win result for all stakeholders: the Sponsor, the CRO and the Patients.