NEW YORK, Aug. 10 Reportlinker.com announces that a new market research report is available in its catalogue:
Streamlining Clinical Trials (PH117)
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Refine processes to accelerate and improve clinical trials
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.
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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
Companies Included in Report
Abbott Labs
Allergan
Amgen
AstraZeneca
Baxter Healthcare
Bristol-Myers Squibb
Covance
Cephalon
CSP
EmpiriStat
Genzyme
Gilead Sciences
GlaxoSmithKline
GlobeImmune
Hill-Rom
InNexus Biotech
Isotechnika
Medarex
Merck
Millennium Pharmaceuticals
Neurogen
Nycomed
Onyx Pharmaceuticals
Ortho-McNeil Janssen
PDL Biopharma
Pfizer
Pharma Consulting Solutions
PPD
ResearchLink
Sanofi-Aventis
Schering-Plough
Teva
UCB Pharmaceuticals
Metrics Included in the Report:
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)
*for pharmaceutical, biotechnology and medical device companies
- 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
1. Executive Summary
2. Sub-header
2.1. Report findings: Current and Future Trends
2.2. Study Methodology
2.3. Profiled Companies
2.4. Clinical Operations: Principles for Success
3. Clinical Trials Resource Allocation
3.1. Per Patient Costs and Outsourced Spending
3.2. Therapeutic Area Costs per Patient
3.3. Clinical Operations Budgeting Process
3.4. Phase-by-Phase Clinical Staffing
3.5. Other Staffing Metrics
4. Clinical Trial Performance Measurement
4.1. Clinical Trial Performance Metrics Tracked
5. Continuous Process Improvement
5.1. Study Planning and Set Up
5.2. Study Conduct
5.3. Study Analysis and Close Out
6. Recruiting and Retaining Patients and Investigators
6.1. Enrolling Patients through Effective Recruitment Methods
6.2. Patient Retention and Compliance
6.3. Investigator Recruitment and Incentives
7. Adaptive Clinical Trial Design
To order this report:
Biotechnology Industry: Streamlining Clinical Trials (PH117)
Biotechnology Business News
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Nicolas Bombourg Reportlinker Email: [email protected] US: (805)652-2626 Intl: +1 805-652-2626
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