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Reportlinker Adds Streamlining Clinical Trials (PH117)

Wednesday, August 11, 2010 Hospital News J E 4
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NEW YORK, Aug. 10 Reportlinker.com announces that a new market research report is available in its catalogue:

Streamlining Clinical Trials (PH117)

http://www.reportlinker.com/p0254411/Streamlining-Clinical-Trials-PH117.html

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.

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

More Market Research Report

Check our Company Profile, SWOT and Revenue Analysis!

Nicolas Bombourg Reportlinker Email: nbo@reportlinker.com US: (805)652-2626 Intl: +1 805-652-2626

SOURCE Reportlinker
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