Post-Marketing (Phase 4) Study Excellence

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This report focuses on Phase 4 studies in terms of strategy, resources, timelines and trends. Use data from across the industry to determine best-fit postmarketing alignment across global and regional-level teams, and expertly leverage medical affairs and clinical groups — among other teams — to execute smooth postmarketing studies. Data include trial timelines and schedules for study planning and execution, budget allocations, and breakdowns of major study types (observational studies, interventional studies and retrospective studies).

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Report Details

This report focuses on postmarketing study strategy, resources, timelines and trends.  It examines postmarketing studies by comparing data about companies’ number and percentage of studies that are interventional, observational and retrospective.  It will help to identify trends in interventional trial design innovations and in observational studies to learn the benefits and risks of different trial designs and much more!

  • 6 chapters + an Executive Summary
  • 115 graphics
  • 5 appendix tables

Data have been split by team region:

  • Global
  • US
  • Country-Level

Data have also been split by company size:

  • Top 10
  • Top 50
  • Small
  • Device

Study case studies:

  • Interventional
  • Observational
  • Retrospective

Top Reasons to Buy This Phase 4 Studies Benchmarking Report

Benchmark your post-marketing and Phase 4 trial timelines: One critical measure of post-marketing study productivity is the trial timeline. Time is money, and unreasonably long timelines both hurt the company financially and could hurt the studied product’s market position should competitors collect late-stage data faster. The study includes detailed metrics to benchmark your study timelines against the typical duration for interventional, observational and retrospective trials. 

Compare relative study costs to determine future spending: Although Phase 4 and post-marketing study cost is not the primary consideration for pursuing a specific trial, it is an important factor. The report’s data show percentage of annual costs allocated to different post-marketing study types. It also compares study costs for interventional, observational and retrospective among Top 10, Top 50 and small pharmaceutical companies. The data are also broken down to show costs for global, US, European and Latin American regions.

Leverage medical affairs’ expertise to guide post-marketing study development:
This report provides an in-depth discussion regarding companies’ general post-marketing study structures, including the functions involved and the responsibilities they undertake. The study includes a particular focus on medical affairs teams, who often provide additional guidance on Phase 4 activities. In fact, among all companies surveyed, medical affairs functions overwhelmingly handle the planning aspect of post-marketing research. The study found that surveyed life science teams with 78% of dedicated post-marketing study groups are aligned under medical affairs.

Outsource post-marketing study activities to decrease average duration from protocol design to training: A common point of discussion is whether the sponsor company should outsource its Phase 4 and post-marketing studies. After all, outsourcing certain activities can provide efficiency and speed during Phase 4. This report breaks down the most commonly outsourced post-marketing study activities, as well as those activities which make more sense to retain in-house.

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Excerpt from Postmarketing Study Excellence

Postmarketing studies are undergoing a revolution. No longer seen as optional, late stage studies are conducted to investigate product effectiveness, health economic outcomes, product utilization and other key data not readily collected in Phase 3 trials. Phase 4 studies are necessary for some products to maintain market authorization and are crucial for earning product reimbursement and market share.

Late-stage study teams are innovating trial designs beyond traditional randomized controlled trials (RCTs) to examine specific endpoints and to collect real-world data. These study designs include newer interventional studies such as pragmatic RCTs as well as advances in observational and retrospective studies. This report analyzes the percentage of postmarketing studies that adhere to different interventional and observational study designs and compares benchmarks for these designs.

EXAMPLES OF COMPANIES THAT HAVE PARTICIPATED IN THIS STUDY:

Post-Marketing (Phase 4) Study Participation List

Table of Contents

11           Executive Summary

12           Postmarketing Studies: Key Recommendations for Success

23           About This Report

29           Promote Efficient Phase 4 Oversight Capabilities with Robust Postmarketing Structures and Staffing

33           Organizing Postmarketing Structures: The Hierarchy of Dedicated Groups Across Global and Regional Team Levels

47           The Process Behind Building a Postmarketing Strategy

49           Resourcing and Staffing Postmarketing Studies

50           Optimizing Budgets to Support Phase 4 Research

63           Staffing Effective Postmarketing Teams

68           Outsourcing Postmarketing Activities to Maximize Capabilities

76           Postmarketing Study Trends

87           Postmarketing Study Objectives

102        Lifecycle Stage When Study Planning and Execution Begin

105        Consider Number of Studies per Product When Planning Number of Studies Conducted

113        Types of Conducted Studies Consistent Across Years and Regions

122        References

123        Diversify Interventional Study Designs to Yield Informative Clinical Findings

127        Interventional Study Trends

135        Interventional Study Resources

143        Interventional Study Timelines

149         Interventional Study Profiles

176        References

177        Explore Real-World Data with Observational Studies

180        Observational Study Trends

192        Observational Study Resources

202        Observational Study Timelines

208         Observational Study Profiles

230        References

231        Maximize Retrospective Study Outcomes Through Early Planning

237        Retrospective Study Resources: Leverage Internal Expertise to Conserve Associated Costs

245        Study Execution: Activity Timelines and Challenges

250         Retrospective Study Profiles

270        Appendix

CHARTS AND GRAPHICS

11           Executive Summary

12           Postmarketing Studies: Key Recommendations for Success

13           Figure E.1: Functions Involved in Different Postmarketing Study Activities

16           Figure E.2: Average Number of Postmarketing Studies per Product, by Company Size and Year

17           Figure E.3: Percentage of Companies Outsourcing Specific Postmarketing Trial Activities

18           Figure E.4: Number of Days to Complete Specific Postmarketing Trial Activities

20           Figure E.5: Percentage of Companies Providing the Product to Patients for Observational Studies

22           Figure E.6: Primary Objectives for Postmarketing Studies: 2015, by Team Region

29           Promote Efficient Phase 4 Oversight Capabilities with Robust Postmarketing Structures and Staffing

30           Figure 1.1: Function Under Which Dedicated Postmarketing Studies Teams Sit

33           Organizing Postmarketing Structures: The Hierarchy of Dedicated Groups Across Global and Regional Team Levels

34           Figure 1.2: Postmarketing Studies Groups’ Scope of Responsibility at Surveyed Companies, by Team Region

34           Figure 1.3: Postmarketing Studies Groups’ Scope of Responsibility at Surveyed Companies, by Company Size

38           Figure 1.4: Functions Involved in Certain Postmarketing Study Activities

42           Figure 1.5: Percentage of Teams with Certain Functions Involved in Study Strategic Planning, by Team Region

44           Figure 1.6: Percentage of Teams with Certain Functions Involved in Study Execution, by Team Region

47           The Process Behind Building a Postmarketing Strategy

49           Resourcing and Staffing Postmarketing Studies

50           Optimizing Budgets to Support Phase 4 Research

51           Figure 2.1: Postmarketing Study Costs, by Year: Global Teams

52           Figure 2.2: Postmarketing Study Costs, by Year: Small Company 14’s US Team

53           Figure 2.3: Postmarketing Study Costs, by Year: Country-Level Teams

54           Figure 2.4: Postmarketing Study Costs, by Year: Device Company 23’s Country-Level Team

56           Figure 2.5: Percentage of Study Costs Allocated to Different Types of Studies, by Year: Global Teams

57           Figure 2.6: Percentage of Study Costs Allocated to Different Types of Studies, by Year: Country-Level Teams

58           Figure 2.7: Total Interventional Study Costs, by Year

59           Figure 2.8: Total Observational Study Costs, by Year

60           Figure 2.9: Total Retrospective Study Costs, by Year

61           Figure 2.10: Postmarketing Study Team Salaries and Overhead Costs: Top 10 Company 1’s Global Team

62           Figure 2.11: Postmarketing Study Team Salaries and Overhead Costs: Country-Level Teams

63           Staffing Effective Postmarketing Teams

64           Figure 2.12: Postmarketing Studies Team Size, by Year: Global Teams

64           Figure 2.13: Percentage Change in Staffing: Global Teams

65           Figure 2.14: Postmarketing Studies Team Size, by Year: US Teams

66           Figure 2.15: Postmarketing Studies Team Size, by Year: Country-Level Teams

67           Figure 2.16: Percentage Change in Postmarketing Team Staffing: Country-Level Teams

68           Outsourcing Postmarketing Activities to Maximize Capabilities

69           Figure 2.17: Percentage of Actual Study Costs Outsourced, by Study Type

72           Figure 2.18: Comparing Timelines and Outsourcing Practices: Protocol Development

73           Figure 2.19: Comparing Timelines and Outsourcing Practices: Investigator and Site Recruitment

74           Figure 2.20: Comparing Timelines and Outsourcing Practices: Investigator and Site Contract Negotiations

75           Figure 2.21: Comparing Timelines and Outsourcing Practices: Investigator and Site Training

76           Postmarketing Study Trends

78           Figure 3.1: Use of Digital Technology in Postmarketing Studies, by Study Type

83           Figure 3.2: Percentage of US Studies Requiring an IND, by Study Type

85           Figure 3.3: Range and Average Number of Days Spent from Study Planning to Submission of Manuscript for Publication

86           Figure 3.4: Range and Average Number of Days Spent from Study Planning to First Patient In Study

87           Postmarketing Study Objectives

88           Figure 3.5: Average Primary Objectives for Postmarketing Studies, by Year: All Teams

92           Figure 3.6: Average Primary Objectives for Postmarketing Studies, by Year: Global Teams

94           Figure 3.7: Average Primary Objectives for Postmarketing Studies, by Year: US Teams

96           Figure 3.8: Average Primary Objectives for Postmarketing Studies, by Year: Country-Level Teams

99           Figure 3.9: Primary Objectives for Postmarketing Studies, by Study Type

101        Figure 3.10: Primary Objectives for Postmarketing Studies, by Product Type

102        Lifecycle Stage When Study Planning and Execution Begin

102        Figure 3.11: Stage When Postmarketing Study Planning and Execution Began: All Studies

104        Figure 3.12: Stage When Postmarketing Study Execution Began, by Product Type

105        Consider Number of Studies per Product When Planning Number of Studies Conducted

107        Figure 3.13: Total and Average Number of Studies per Product for 2014, by Company: Global Teams

107        Figure 3.14: Total and Average Number of Studies per Product for 2015, by Company: Global Teams

108        Figure 3.15: Total and Average Number of Studies per Product for 2016, by Company: Global Teams

109        Figure 3.16: Total and Average Number of Studies per Product for 2014, by Company: US Teams

110        Figure 3.17: Total and Average Number of Studies per Product for 2015, by Company: US Teams

110        Figure 3.18: Total and Average Number of Studies per Product for 2016, by Company: US Teams

111        Figure 3.19: Total and Average Number of Studies per Product for 2014, by Company: Country-Level Teams

112        Figure 3.20: Total and Average Number of Studies per Product for 2015, by Company: Country-Level Teams

112        Figure 3.21: Total and Average Number of Studies per Product for 2016, by Company: Country-Level Teams

113        Types of Conducted Studies Consistent Across Years and Regions

114        Figure 3.22: Average Percentage of Postmarketing Studies That Are Certain Study Types, by Year: All Teams

115        Figure 3.23: Average Percentage of Postmarketing Studies That Are Certain Study Types, by Team Region: 2015

116        Figure 3.24: Number of Postmarketing Studies Conducted in 2014, by Study Type: Global Teams

117        Figure 3.25: Number of Postmarketing Studies Conducted in 2015, by Study Type: Global Teams

117        Figure 3.26: Number of Postmarketing Studies Conducted in 2016, by Study Type: Global Teams

118        Figure 3.27: Number of Postmarketing Studies Conducted in 2014, by Study Type: US Teams

119        Figure 3.28: Number of Postmarketing Studies Conducted in 2015, by Study Type: US Teams

119        Figure 3.29: Number of Postmarketing Studies Conducted in 2016, by Study Type: US Teams

120        Figure 3.30: Number of Postmarketing Studies Conducted in 2014, by Study Type: Country-Level Teams

121        Figure 3.31: Number of Postmarketing Studies Conducted in 2015, by Study Type: Country-Level Teams

121        Figure 3.32: Number of Postmarketing Studies Conducted in 2016, by Study Type: Country-Level Teams

122        References

123        Diversify Interventional Study Designs to Yield Informative Clinical Findings

124        Figure 4.1: Percentage of Teams Conducting Interventional Studies, by Year

125        Figure 4.2: Percentage of Interventional Studies That Included Retrospective Data

127        Interventional Study Trends

129        Figure 4.3: Average Percentage of Interventional Studies Following Particular Trial Designs

131        Figure 4.4: Objectives for Traditional RCTs

133        Figure 4.5: Percentage of Target Patient Enrollment Achieved: Interventional Studies

134        Figure 4.6: Number of Patients per Site: Interventional Studies

135        Interventional Study Resources

136        Figure 4.7: Difference in Planned and Actual Study Costs: Interventional Studies

137        Figure 4.8: Percentage of Actual Study Costs Outsourced: Interventional Studies

139        Figure 4.9: Percentage of Interventional Studies That Outsourced Certain Items

140        Figure 4.10: Number of Days Spent Recruiting and Selecting Vendors: Interventional Studies

141        Figure 4.11: Number of Days Spent Negotiating Vendor Contracts: Interventional Studies

142         Figure 4.12: Total Staffing for Interventional Studies

143        Interventional Study Timelines

143        Figure 4.13: Stage When Study Planning and Execution Began: Interventional Studies

144        Figure 4.14: Number of Days Spent from Study Planning to First Patient In: Interventional Studies

145        Figure 4.15: Number of Days Spent from First Patient In to Last Patient In: Interventional Studies

146        Figure 4.16: Number of Days Spent from Last Patient In to Data Lock: Interventional Studies

147        Figure 4.17: Number of Days Spent from Data Lock to Submission of Manuscript for Publication: Interventional Studies

148        Figure 4.18: Number of Days Spent Training Investigators and Sites: Interventional Studies

149         Interventional Study Profiles

152        Figure 4.19: Interventional Study A: Background

153        Figure 4.20: Interventional Study A: Costs and Outsourcing

154        Figure 4.21: Interventional Study A: Staffing

155        Figure 4.22: Interventional Study A: Study Timeline

157        Figure 4.23: Interventional Study H: Background

158        Figure 4.24: Interventional Study H: Costs and Outsourcing

159         Figure 4.25: Interventional Study H: Staffing

160        Figure 4.26: Interventional Study H: Study Timeline

162        Figure 4.27: Interventional Study I: Background

163        Figure 4.28: Interventional Study I: Costs and Outsourcing

164         Figure 4.29: Interventional Study I: Staffing

165        Figure 4.30: Interventional Study I: Study Timeline

167        Figure 4.31: Interventional Study J: Background

168        Figure 4.32: Interventional Study J: Costs and Outsourcing

169         Figure 4.33: Interventional Study J: Staffing

170        Figure 4.34: Interventional Study J: Study Timeline

172        Figure 4.35: Interventional Study M: Background

173        Figure 4.36: Interventional Study M: Costs and Outsourcing

174         Figure 4.37: Interventional Study M: Staffing

175        Figure 4.38: Interventional Study M: Study Timeline

176        References

177        Explore Real-World Data with Observational Studies

178        Figure 5.1: Percentage of Teams Conducting Observational Studies, by Year

179        Figure 5.2: Percentage of Observational Studies That Included Retrospective Data

180        Observational Study Trends

182        Figure 5.3: Average Percentage of Observational Studies Following Particular Trial Designs

185        Figure 5.4: Percentage of Observational Studies with Certain Objectives, by Study Design

187        Figure 5.5: Percentage of Target Patient Enrollment Achieved: Observational Studies

189        Figure 5.6: Number of Patients per Site: Observational Studies

191        Figure 5.7: Percentage of Companies Providing the Product to Patients for Observational Studies

192        Observational Study Resources

193        Figure 5.8: Difference in Planned and Actual Study Costs: Observational Studies

194        Figure 5.9: Percentage of Actual Study Costs Outsourced: Observational Studies

196        Figure 5.10: Percentage of Observational Studies That Outsourced Certain Items

197        Figure 5.11: Number of Days Spent Recruiting and Selecting Vendors: Observational Studies

198        Figure 5.12: Number of Days Spent Negotiating Vendor Contracts: Observational Studies

200        Figure 5.13: Total Staffing for Observational Studies

202        Figure 5.14: Stage When Study Planning and Execution Began: Observational Studies

202        Observational Study Timelines

203        Figure 5.15: Number of Days Spent from Study Planning to First Patient In: Observational Studies

204        Figure 5.16: Number of Days Spent from First Patient In to Last Patient In: Observational Studies

205        Figure 5.17: Number of Days Spent from Last Patient In to Data Lock: Observational Studies

206        Figure 5.18: Number of Days Spent from Data Lock to Submission of Manuscript for Publication: Observational Studies

207        Figure 5.19: Number of Days Spent Training Investigators and Sites: Observational Studies

208         Observational Study Profiles

211        Figure 5.20: Observational Study B: Background

212        Figure 5.21: Observational Study B: Costs and Outsourcing

213         Figure 5.22: Observational Study B: Staffing

214        Figure 5.23: Observational Study B: Study Timeline

216        Figure 5.24: Observational Study R: Background

217        Figure 5.25: Observational Study R: Costs and Outsourcing

218         Figure 5.26: Observational Study R: Staffing

219        Figure 5.27: Observational Study R: Study Timeline

221        Figure 5.28: Observational Study V: Background

222        Figure 5.29: Observational Study V: Costs and Outsourcing

223         Figure 5.30: Observational Study V: Staffing

224        Figure 5.31: Observational Study V: Study Timeline

226        Figure 5.32: Observational Study AA: Background

227        Figure 5.33: Observational Study AA: Costs and Outsourcing

228         Figure 5.34: Observational Study AA: Staffing

229        Figure 5.35: Observational Study AA: Study Timeline

230        References

231        Maximize Retrospective Study Outcomes Through Early Planning

232        Figure 6.1: Percentage of Teams Conducting Retrospective Studies, by Year

233         Figure 6.2: Source of Data for Retrospective Studies

236        Figure 6.3: Objectives for Retrospective Studies

237        Retrospective Study Resources: Leverage Internal Expertise to Conserve Associated Costs

238        Figure 6.4: Difference in Planned and Actual Study Costs: Retrospective Studies

240        Figure 6.5: Percentage of Actual Study Costs Outsourced: Retrospective Studies

240        Figure 6.6: Percentage of Retrospective Studies That Outsource Certain Items

241        Figure 6.7: Number of Days Spent Recruiting and Selecting Vendors: Retrospective Studies

242        Figure 6.8: Number of Days Spent Negotiating Vendor Contracts: Retrospective Studies

243         Figure 6.9: Total Staffing for Retrospective Studies

245        Study Execution: Activity Timelines and Challenges

246        Figure 6.10: Stage When Study Planning and Execution Began: Retrospective Studies

247        Figure 6.11: Number of Days Spent from Study Planning to Protocol Approval: Retrospective Studies

248        Figure 6.12: Number of Days Spent from Protocol Approval to Data Lock: Retrospective Studies

248        Figure 6.13: Number of Days Spent from Data Lock to Submission of Manuscript for Publication: Retrospective Studies

250         Retrospective Study Profiles

254        Figure 6.14: Retrospective Study A: Background

255        Figure 6.15: Retrospective Study A: Costs and Outsourcing

256         Figure 6.16: Retrospective Study A: Staffing

257        Figure 6.17: Retrospective Study A: Study Timeline

258        Figure 6.18: Retrospective Study I: Background

259        Figure 6.19: Retrospective Study I: Costs and Outsourcing

260         Figure 6.20: Retrospective Study I: Staffing

261        Figure 6.21: Retrospective Study I: Study Timeline

262        Figure 6.22: Retrospective Study L: Background

263        Figure 6.23: Retrospective Study L: Costs and Outsourcing

264         Figure 6.24: Retrospective Study L: Staffing

265        Figure 6.25: Retrospective Study L: Study Timeline

266        Figure 6.26: Retrospective Study N: Background

267        Figure 6.27: Retrospective Study N: Costs and Outsourcing

268         Figure 6.28: Retrospective Study N: Staffing

269        Figure 6.29: Retrospective Study N: Study Timeline

270        Appendix

271        Table 1: Interventional Study Background Information

272        Table 2: Interventional Study Enrollment and Costs

273        Table 3: Observational Study Background Information

274        Table 4: Observational Study Enrollment and Costs

275        Table 5: Retrospective Study Background Information