Clinical Development and Trial Operations

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Clinical cost drivers may include trial location, required medical procedures, manufacturing costs and, in some cases, the need to supply a comparator drug.  This report presents trial costs — both overall trial costs and per-patient trial costs — for 22 different therapeutic areas, including cardiovascular, central nervous system, diabetes, and early- and late-stage oncology. Data in this benchmarking study were compiled from primary sources, including surveys and interviews with clinical vice presidents, directors and trial managers.

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Report Details

Publication Date: Nov 2013
Pages: 221
Chapters: 5
Metrics: 500+
Charts/Graphics: 147

Top Reasons to Buy This Clinical Development And Trial Operations Report

Reduce and Avoid Costly Trial Delays: The average delay in a clinical trial’s durations is 25% beyond the expected timeline.  The report includes recommendations from experienced drug developers and CROs that have implemented best practices for minimizing clinical trial delays, managing non-performing sites and accelerating site initiation and contracting.  Furthermore, the report’s data reveal how much time and money companies should invest to not only plan for trial delays, but also to avoid them completely.

Benchmark Clinical Development Costs: Clinical trial costs rise in tandem with healthcare costs, but other market forces also have a profound impact on clinical development investment.  Early-stage trials have shown a dramatic rise in per-patient costs as clinical teams look to collect more data earlier in the drug development process.  Overall trial costs are also rising.  Compare per-patient costs for each drug development phase in 25 therapeutic areas.

Balance In-house Resources with Outsourced Expertise: Sponsor companies share the need to recruit experienced trial staff to run clinical studies.  Several factors — including development phase and therapeutic area — drive trial staffing decisions.  The report provides key recommendations for vendor/CRO management.  Benchmark your company’s clinical outsourcing performance using detailed metrics for more than 450 trials across multiple therapeutic areas.

Adopt Patient Centric Strategies: The industry’s trend toward patient-centric models has impacted clinical development.  Drug manufacturers now design clinical protocols that center on patients, providing exceptional care and lessening the burden of participating in research.  Use this report to learn how companies improve investigator and site support through patient-centric protocol development.  Create understandable and easily implemented protocols that remove large burdens from the patients.

You may also be interested in CEIConnect: The Lifesciences Industry’s On-Demand Research Resource.

Excerpt from Clinical Development and Trial Operations

The healthcare industry has seen several major shifts over the past five years.
Austerity measures have strained the reimbursement climate in many EU countries and caused government payers to scrutinize each new drug like never before. Healthcare reform in the US has the potential to add coverage for 30 million uninsured Americans. As a result, pharmaceutical companies must work even harder to gain favorable formulary placement with private payers.

While there are several regional differences, one thing is universal: regulators and payers want more data. With the stakes raised, the value of that data has never been higher. For a new drug, regulatory approval is no longer the finish line. Clinical development teams must arm their commercial organizations and market access teams with the most useful data, as early as possible. Meeting this responsibility means building rigorous safety, efficacy and even health economic endpoints into early-stage trial protocols. This preparation is not something that comes naturally to every clinical team. Scientists are not taught to consider value propositions in their university textbooks. And adding months to a trial protocol to better capture health outcomes data may seem unnecessary and inconsequential to the advancement of science.

Table of Contents

8              Executive Summary

13           Study Methodology

14           Study Definitions

16           Clinical Operations: Key Findings

28           Aligning Trial Structure with Clinical Strategy

29           Build Dedicated Clinical Structures to Preserve Economies of Scale

42           Developing Robust Clinical Team Staffing and Outsourcing Strategies

43           Align Staffing with Trial Objectives and In-House Capabilities

48           Clinical Teams’ Staffing by Therapeutic Area

84           Maximizing Vendor Capabilities and Facilitating Third-Party Relationships

95           Recruiting CROs: A Look at the Formal Vendor Selection Process

100         Protocol Design and Site Management

101         Patient-Centric Protocol Design

121         Strategic Site Selection

139         Conducting Efficient Clinical Trials

140         Trial Duration

145         Boosting Patient Recruitment

152         Clinical Trial Progress: Timelines to Achieve Key Milestones

162         Maintaining High Patient Retention Rates

165         Clinical Trial Budgets and Per-Patient Costs

166         Demand for Clinical Data Drives Budgets Higher

174         Benchmarking Clinical Trial Costs by Therapeutic Area

Charts and Graphics

8              Executive Summary

13           Study Methodology

14           Study Definitions

16           Figure E.1: Average Per-Patient Clinical Trial Costs, by Phase

16           Clinical Operations: Key Findings

19           Figure E.2: Average Delay for Clinical Trials, by Phase

22           Figure E.3: Patient Screening Rates, by Phase

23           Figure E.4: Average Patient Retention Rate, by Phase

24           Figure E.5: Percentage of Companies Outsourcing Some Portion of Clinical Trial Costs

26           Figure E.6: Average Ratio of Patients per CRA, by Phase

26           Figure E.7: Average Ratio of Investigator Sites per CRA, by Phase

28           Aligning Trial Structure with Clinical Strategy

29           Build Dedicated Clinical Structures to Preserve Economies of Scale

29           Figure 1.1: Companies’ Clinical Operations Structures

30           Figure 1.2: Number of Therapeutic Areas Studied, by Company Type

31           Figure 1.3: Number of Companies Conducting Clinical Trials, by Therapeutic Area

35           Figure 1.4: Clinical Team Structure: Company E (Large Pharma)

37           Figure 1.5: Clinical Team Structure: Company I (Mid-Sized Pharma)

39           Figure 1.6: Clinical Team Structure: Company L (Small Pharma)

40           Figure 1.7: Team Structure: Company K (Biotech)

41           Figure 1.8: Clinical Team Structure: Company A (CRO)

42           Developing Robust Clinical Team Staffing and Outsourcing Strategies

43           Align Staffing with Trial Objectives and In-House Capabilities

46           Figure 2.1: Average Ratio of Patients per CRA, by Phase

47           Figure 2.2: Average Ratio of Investigator Sites per CRA, by Phase

48           Clinical Teams’ Staffing by Therapeutic Area

49           Figure 2.3: Trials’ Total CRA Staffing, by Therapeutic Area

50           Figure 2.4: Patients per CRA in Cardiovascular Trials

51           Figure 2.5: Sites per CRA in Cardiovascular Trials

53           Figure 2.6: Patients per CRA in Central Nervous System Trials

54           Figure 2.7: Sites per CRA in Central Nervous System Trials

55           Figure 2.8: Patients per CRA in Dermatology Trials

56           Figure 2.9: Sites per CRA in Dermatology Trials

57           Figure 2.10: Patients per CRA in Diabetes (Type 2) Trials

58           Figure 2.11: Sites per CRA in Diabetes (Type 2) Trials

59           Figure 2.12: Patients per CRA in Endocrinology Trials

60           Figure 2.13: Sites per CRA in Endocrinology Trials

61           Figure 2.14: Patients per CRA in Gastroenterology Trials

62           Figure 2.15: Sites per CRA in Gastroenterology Trials

63           Figure 2.16: Patients per CRA in Hematology Trials

64           Figure 2.17: Sites per CRA in Hematology Trials

65           Figure 2.18: Patients per CRA in Infectious Disease Trials

66           Figure 2.19: Sites per CRA in Infectious Disease Trials

67           Figure 2.20: Patients per CRA in Medical Device Trials

68           Figure 2.21: Sites per CRA in Medical Device Trials

69           Figure 2.22: Patients per CRA in Musculoskeletal Trials

70           Figure 2.23: Sites per CRA in Musculoskeletal Trials

72           Figure 2.24: Patients per CRA in Early-Stage Oncology Trials

73           Figure 2.25: Patients per CRA in Late-Stage Oncology Trials

74           Figure 2.26: Sites per CRA in Early-Stage Oncology Trials

75           Figure 2.27: Sites per CRA in Late-Stage Oncology Trials

76           Figure 2.28: Patients per CRA in Respiratory Trials

77           Figure 2.29: Sites per CRA in Respiratory Trials

78           Figure 2.30: Patients per CRA in Rheumatology Trials

79           Figure 2.31: Sites per CRA in Rheumatology Trials

80           Figure 2.32: Patients per CRA in Urology Trials

81           Figure 2.33: Sites per CRA in Urology Trials

82           Figure 2.34: Patients per CRA in Women’s Health Trials

83           Figure 2.35: Sites per CRA in Women’s Health Trials

84           Figure 2.36: Percentage of Companies Outsourcing Some Portion of Clinical Trial Costs

84           Maximizing Vendor Capabilities and Facilitating Third-Party Relationships

85           Figure 2.37: Average Percentage of Total Trial Cost Outsourced, by Company Type

87           Figure 2.38: Average Number of Outsourced Staff, by Subgroup/Team

88           Figure 2.39: Percentage of Companies that Outsource Clinical Operations Staffing

90           Figure 2.40: Average Percentage of Total Trial Cost Outsourced, by Phase

92           Figure 2.41: Average Percentage of Total Trial Cost Outsourced, by Therapeutic Area

95           Recruiting CROs: A Look at the Formal Vendor Selection Process

100         Protocol Design and Site Management

101         Patient-Centric Protocol Design

102         Figure 3.1: Time Spent (in Months) Planning Protocol, by Phase

104         Figure 3.2: Time (in Months) to Earn IRB/Ethics Approval, by Phase

108         Figure 3.3: Number of Office Visits Required by Protocol, by Phase

109         Figure 3.4: Number of Office Visits Required by Protocol, by Therapeutic Area

112         Figure 3.5: Number of Amendments per Protocol, by Phase

113         Figure 3.6: Number of Amendments per Protocol, by Therapeutic Area

115         Figure 3.7: Patient Screening Rates, by Phase

116         Figure 3.8: Patient Screening Rates, by Therapeutic Area

118         Figure 3.9: Percentage of Trials Using Adaptive Design, by Phase

121         Strategic Site Selection

122         Figure 3.10: Average Number of Investigator Sites Used, by Phase

124         Figure 3.11: Average Ratio of Patients per Investigator Site, by Phase

125         Figure 3.12: Average Ratio of Patients per Site, by Therapeutic Area

127         Figure 3.13: Percentage of Non-Performing Sites, by Phase

129         Figure 3.14: Percentage of Non-Performing Sites, by Therapeutic Area

139         Conducting Efficient Clinical Trials

140         Trial Duration

141         Figure 4.1: Average Duration (in Months) of Clinical Trials, by Phase

143         Figure 4.2: Average Delay for Clinical Trials, by Phase

144         Figure 4.3: Average Delay for Clinical Trials, by Therapeutic Area

145         Boosting Patient Recruitment

151         Figure 4.4: Average Number of Patients Enrolled in Clinical Trials, by Phase

152         Figure 4.5: Average Number of Months to Achieve Key Trial Milestones: Phase 1

152         Clinical Trial Progress: Timelines to Achieve Key Milestones

153         Figure 4.6: Average Delay in Achieving Trial Milestones: Phase 1

154         Figure 4.7: Average Number of Months to Achieve Key Trial Milestones: Phase 2

155         Figure 4.8: Average Delay in Achieving Trial Milestones: Phase 2

156         Figure 4.9: Average Number of Months to Achieve Key Trial Milestones: Phase 3a

157         Figure 4.10: Average Delay in Achieving Trial Milestones: Phase 3a

158         Figure 4.11: Average Number of Months to Achieve Key Trial Milestones: Phase 3b

159         Figure 4.12: Average Delay in Achieving Trial Milestones: Phase 3b

160         Figure 4.13: Average Number of Months to Achieve Key Trial Milestones: Phase 4

161         Figure 4.14: Average Delay in Achieving Trial Milestones: Phase 4

162         Maintaining High Patient retention Rates

164         Figure 4.15: Average Patient Retention Rate, by Phase

165         Clinical Trial Budgets and Per-Patient Costs

166         Demand for Clinical Data Drives Budgets Higher

167         Figure 5.1: Average Total Cost for Clinical Trials, by Phase: All Therapeutic Areas

171         Figure 5.2: Average Per-Patient Clinical Trial Costs: All Therapeutic Areas

174         Benchmarking Clinical trial costs by therapeutic area

176         Figure 5.3: Per-Patient Clinical Trial Costs: Arthritis (Non-Rheumatic)

177         Figure 5.4: Total Cost for Clinical Trials: Early-Stage Arthritis (Non-Rheumatic)

177         Figure 5.5: Total Cost for Clinical Trials: Late-Stage Arthritis (Non-Rheumatic)

178         Figure 5.6: Total Cost for Clinical Trials: Early-Stage Autoimmune

179         Figure 5.7: Total Cost for Clinical Trials: Late-Stage Autoimmune

180         Figure 5.8: Total Cost for Clinical Trials: Cardiology and Thrombosis

182         Figure 5.9: Per-Patient Clinical Trial Costs: Cardiovascular Diseases

182         Figure 5.10: Total Cost for Clinical Trials: Early-Stage Cardiovascular Diseases

183         Figure 5.11: Total Cost for Clinical Trials: Late-Stage Cardiovascular Diseases

185         Figure 5.12: Per-Patient Clinical Trial Costs: Early-Stage Central Nervous System

185         Figure 5.13: Per-Patient Clinical Trial Costs: Late-Stage Central Nervous System

186         Figure 5.14: Total Cost for Clinical Trials: Early-Stage Central Nervous System

186         Figure 5.15: Total Cost for Clinical Trials: Late-Stage Central Nervous System

187         Figure 5.16: Per-Patient Clinical Trial Costs: Dermatology

188         Figure 5.17: Total Cost for Clinical Trials: Early-Stage Dermatology

188         Figure 5.18: Total Cost for Clinical Trials: Late-Stage Dermatology

190         Figure 5.19: Total Cost for Clinical Trials: Diabetes (Type 1)

190         Figure 5.20: Per-Patient Clinical Trial Costs: Diabetes (Type 2)

191         Figure 5.21: Total Cost for Clinical Trials: Early-Stage Diabetes (Type 2)

191         Figure 5.22: Total Cost for Clinical Trials: Late-Stage Diabetes (Type 2)

192         Figure 5.23: Per-Patient Clinical Trial Costs: Endocrinology/Metabolic Diseases (Non Diabetes)

193         Figure 5.24: Total Cost for Clinical Trials: Early-Stage Endocrinology/Metabolic Diseases (Non-Diabetes)

193         Figure 5.25: Total Cost for Clinical Trials: Late-Stage Endocrinology/Metabolic Diseases (Non-Diabetes)

194         Figure 5.26: Per-Patient Clinical Trial Costs: Gastroenterology

195         Figure 5.27: Total Cost for Clinical Trials: Early-Stage Gastroenterology

195         Figure 5.28: Total Cost for Clinical Trials: Late-Stage Gastroenterology

196         Figure 5.29: Per-Patient Clinical Trial Costs: Hematology

197         Figure 5.30: Total Cost for Clinical Trials: Early-Stage Hematology

197         Figure 5.31: Total Cost for Clinical Trials: Late-Stage Hematology

198         Figure 5.32: Total Cost for Clinical Trials: Early-Stage Immunology/Vaccines (Non Autoimmune)

199         Figure 5.33: Total Cost for Clinical Trials: Late-Stage Immunology/Vaccines (Non Autoimmune)

200         Figure 5.34: Per-Patient Clinical Trial Costs: Infectious Disease

201         Figure 5.35: Total Cost for Clinical Trials: Early-Stage Infectious Disease

201         Figure 5.36: Total Cost for Clinical Trials: Late-Stage Infectious Disease

202         Figure 5.37: Total Cost for Clinical Trials: Early-Stage Inflammation (General)

203         Figure 5.38: Total Cost for Clinical Trials: Late-Stage Inflammation (General)

204         Figure 5.39: Total Cost for Clinical Trials: Mental Health/Psychology

205         Figure 5.40: Per-Patient Clinical Trial Costs: Musculoskeletal

206         Figure 5.41: Total Cost for Clinical Trials: Early-Stage Musculoskeletal

206         Figure 5.42: Total Cost for Clinical Trials: Late-Stage Musculoskeletal

208         Figure 5.43: Per-Patient Clinical Trial Costs: Phase 1 Oncology

208         Figure 5.44: Per-Patient Clinical Trial Costs: Phase 2 Oncology

209         Figure 5.45: Per-Patient Clinical Trial Costs: Phase 3 Oncology

209         Figure 5.46: Total Cost for Clinical Trials: Phase 1 Oncology

210         Figure 5.47: Total Cost for Clinical Trials: Phase 2 Oncology

210         Figure 5.48: Total Cost for Clinical Trials: Phase 3 Oncology

211         Figure 5.49: Total Cost for Clinical Trials: Phase 4 Oncology

213         Figure 5.50: Per-Patient Clinical Trial Costs: Respiratory

213         Figure 5.51: Total Cost for Clinical Trials: Early-Stage Respiratory

214         Figure 5.52: Total Cost for Clinical Trials: Late-Stage Respiratory

215         Figure 5.53: Per-Patient Clinical Trial Costs: Rheumatic Diseases/Rheumatology

216         Figure 5.54: Total Cost for Clinical Trials: Early-Stage Rheumatic Diseases/Rheumatology

216         Figure 5.55: Total Cost for Clinical Trials: Late-Stage Rheumatic Diseases/Rheumatology

217         Figure 5.56: Per-Patient Clinical Trial Costs: Urology

218         Figure 5.57: Total Cost for Clinical Trials: Early-Stage Urology

218         Figure 5.58: Total Cost for Clinical Trials: Late-Stage Urology

219         Figure 5.59: Total Cost for Clinical Trials: Virology

220         Figure 5.60: Per-Patient Clinical Trial Costs: Women’s Health

221         Figure 5.61: Total Cost for Clinical Trials: Early-Stage Women’s Health

221         Figure 5.62: Total Cost for Clinical Trials: Late-Stage Women’s Health