Chapter
Postmarket Studies Required upon Drug Approval
Postmarket Studies Required after Drug Approval
Chapter II Inside Clinical Trials:Testing Medical Productsin People
What Is a Clinical Trial?
Why Participate in a Clinical Trial?
What Happens in a Clinical Trial?
How Are People Protected?
What Is Informed Consent?
Where to Get Information on ClinicalTrials
Information Required for InformedConsent
Institutional Review Boards
Chapter III New Drug Approval:FDA’s Consideration of Evidencefrom Certain Clinical Trials
The Use of Non-Inferiority Trials in Obtaining Evidence of aDrug’s Effectiveness
Issues Unique to Non-Inferiority Trials
One-Quarter of NDAs Included Evidencefrom Non-Inferiority Trials and FDAApproved a Majority of These Applications
One-Quarter of NDAs, Many for Antimicrobial Drugs, IncludedEvidence from Non-Inferiority Trials
FDA Approved a Majority of NDAs That Included Evidencefrom Non-Inferiority Trials
Non-Inferiority Trial CharacteristicsVaried and Not All Such Trials ProvidedPrimary Evidence for the Approval ofNDAs
Characteristics Varied Among the Non-Inferiority Trials ThatProvided Primary Evidence for Approval of 18 NDAs
FDA Has Issued Detailed andComprehensive Guidance on the Use ofNon-Inferiority Trials to Establish theEffectiveness of New Drugs
FDA’s March 2010 Draft Guidance Provides DetailedRecommendations on the Use of Non-Inferiority Trials inEstablishing the Effectiveness of New Drugs
FDA’s March 2010 Draft Guidance Provides Broader and MoreComprehensive Recommendations to Supplement PreviouslyIssued Indication-Specific Guidance Documents
Appendix I: New Drug ApplicationsApproved on the Basis of Evidencefrom Non-Inferiority Trials
Appendix II: FDA Guidance DocumentsIssued with Information on the Use ofNon-Inferiority Trials
Chapter IV New Drug Approval:FDA Needs to Enhance ItsOversight of Drugs Approvedon the Basis of SurrogateEndpoints
The Benefits and Risks of Surrogate Endpoints in DrugApproval
FDA Role in the Drug Development and Application ReviewProcess
FDA’s Oversight of Postmarketing Studies
FDA Has Approved Many ApplicationsBased on Surrogate Endpoints through ItsAccelerated Approval Process and aboutTwo-Thirds of Postmarketing StudiesHave Been Closed
FDA Approved 90 Applications Based on Surrogate Endpointsunder the Accelerated Approval Process, the Majority forDrugs to Treat Cancer and HIV/AIDS
FDA Requested over 300 Postmarketing Studies under theAccelerated Process, and About Two-Thirds Have been Closed
FDA Approved about One-Third of NMEDrug Applications Based on SurrogateEndpoints through Its Traditional Processand about Half of the PostmarketingStudies Requested Have Been Closed
About One-Third of the Applications for NME Drugs Approvedunder the Traditional Process Were Based on SurrogateEndpoints, Many for Drugs to Treat Cancer, CardiovascularDisease, and Diabetes
FDA Requested 175 Postmarketing Studies under ItsTraditional Process, and About One-Half Have Been Closed
FDA’s Oversight of Postmarketing StudiesIs Hindered by Weaknesses in ItsMonitoring and Enforcement
FDA Has Not Been Routinely Monitoring the Status ofPostmarketing Studies, although Initiatives to Improve ItsMonitoring Are Underway
FDA Has Not Fully Utilized Its Enforcement Tools Related toRequired Postmarketing Studies
Agency Comments and Our Evaluation
Appendix I: Applications for DrugsApproved under FDA’s AcceleratedApproval Process Using SurrogateEndpoints
Appendix II: Applications for DrugsApproved under FDA’s Traditional ProcessUsing Surrogate Endpoints
Appendix III: Applications Selected andQuestions Regarding FDA’s Oversight ofRequired Postmarketing Studies
Appendix IV: Sales for Selected DrugsApproved Based on Surrogate Endpointsunder the Accelerated Approval Process
FDA Drug Approval: Elements and Considerations
( Pharmacology - Research, Safety Testing and Regulation )
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