Market Report Source

Overview

Executing a successful clinical trial requires seamless communication and coordination among many stakeholders–study sponsors, contract research organizations, academic research organizations, site management organizations, patient recruiters, clinical investigators and patients.

Research shows that there is much room for improvement. The average Phase 1, 2, and 3 trials exceed their timelines by 20%. Delays in the clinical trial process cost pharma companies hundreds of thousands—even millions—in sales. Today, companies also encounter formidable challenges in the clinical development process, including the FDA’s increased involvement.

Streamlining Clinical Trials is the authoritative tool for clinical operations teams to accelerate their trials. This comprehensive guide delves into the latest industry trends and strategies for elevating efficiency. It focuses on resource allocation, performance measurement, continuous process improvement, patient and investigator recruitment and adaptive trial designs. Through extensive benchmarking data, real-company case studies and interviews with industry experts, the report shows how companies are moving their product candidates through development faster and more efficiently.

Use the report to:

• Benchmark your clinical operations against leading companies
• Clarify performance objectives
• Identify and eliminate common trial bottlenecks
• Drive successful patient recruitment campaigns
• Plan study design and protocol effectively
• Discover and apply innovative patient and investigator retention strategies
• Weigh the pros and cons of adaptive trial designs versus traditional trials

Table of Contents

Budget Metrics

Average per-patient clinical trial costs in the US

• by therapeutic area
• by development phase (Phase 1, Phase 2, Phase 3 and Phase 4)

Percentage of clinical development budgets outsourced for US-based trials

• by therapeutic area
• by development phase (Phase 1, Phase 2, Phase 3 and Phase 4)

Cost savings of clinical trials in India
Comparisons to previous data (2006)

Staffing Metrics

Trial-specific staffing for clinical trials covering about 10 therapeutic areas:
Trial size and location(s)

• By development phase (Phase 1, Phase 2, Phase 3 and Phase 4)
• By the following clinical development functions and roles

VPs and therapeutic area supervisors
Trial managers
CRAs/monitors
Data management
Medical writing
Biostatistics/bioanalytics
Regulatory
Clinical quality assurance
Clinical trial supplies
CMC
Contract management
Drug safety
Pharmacovigilance

Percentage of in-house and outsourced staff

• By therapeutic area
• By development phase (Phase 1, Phase 2, Phase 3 and Phase 4)

Patients per CRA

• By development phase (Phase 1, Phase 2, Phase 3 and Phase 4)

Performance Metrics

Percentage of surveyed companies that track various performance measures for:

• Cycle times and time-based trial milestones
• Resource allocation-based metrics (budgets and staffing)
• Efficiency and operations-based measures

Surveyed companies’ assessments of metrics that have power to impact organizational change:

• Cycle times and time-based trial milestones
• Resource allocation-based metrics (budgets and staffing)
• Efficiency and operations-based measures

Other Metrics

Factors impacting rising clinical development costs in the US (2008 vs. 2006 vs. 2004)
Average number of patients per trial

• By therapeutic area
• By development phase (Phase 1, Phase 2 and Phase 3)

Percentages of trials’ time consumed by various trial activities
Surveyed companies’ rankings of opportunities for trial acceleration
Surveyed companies’ rankings of patient recruitment tools (e.g., search engine optimization)
Surveyed companies’ rankings of investigator recruitment tools
Surveyed companies’ rankings of investigator incentives

Adaptive Clinical Trials Design

Percentage of companies performing adaptive trials design
Surveyed companies’ ranking of adaptive clinical trials design versus traditional trials design
Advantages and disadvantages of adaptive clinical trials design