plan early for late phase clinical trials
DESCRIPTION
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.TRANSCRIPT
- 1. FOCUSED. TRUSTED. GLOBAL.
2. FOCUSED. TRUSTED. GLOBAL.Drug Development Life Cycle MAA /NDA submittedPhase IPhase II/IIIMarketing AuthorisationPhase IIIbProduct Development Data to address: Long-term safety Quality of Life Cost-EffectivenessPhase IVCommercializationMaximize product potential 3. 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 4. 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 5. 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, effectivenesso Maximize market penetration New comparators and dosage forms Label extensiono Provide access to yet unregistered drugs EAP/Named Patient/Compassionate use studieso Build relationships with prescribers and payers Brand loyaltyo Health economics and Patient Reported Outcomes Reimbursement 6. FOCUSED. TRUSTED. GLOBAL.Outsourcing for Efficiency o o o o o oFacilitate early planning Leverage previous learning Ensure process clarity Utilize innovative technologies Streamline project execution Maintain organizational focusThe result?Saving 7. 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 8. Summary o http://www.medpace.com/PDF/FactSheetLate_Phase_1_30_rev_2.pdfMedpace Late Phase Capabilities