Drug companies stand to lose between $600,000 and $8 million each day clinical trials delay a drug's development and launch. With so many parties involved in clinical development -- study sponsors, CROs, SMOs, patient recruiters, investigators and patients -- it is no surprise that trials last 30%-42% longer than expected, on average (depending on development Phase). Process standardization, uniform performance measurement, workflow enhancements, and improved patient recruitment are the keys to enhancing your team's clinical performance and accelerating clinical trial timelines.
Accelerating Clinical Trials: Budgets, Patient Recruitment and Productivity explores these important aspects of clinical trial operations. The report draws on input, through surveys and interviews, from executives at 30 top pharmaceutical, biotech, CRO, SMO, and patient recruitment firms. Use the report's real-company budget data, trial activities timelines, performance measures, and detailed case studies to refine your processes and accelerate your company's clinical trials.
Clinical project leaders and team members at study sponsors, CROs, SMOs and patient recruitment firms should be aware of three main aspects of the ever-changing clinical development landscape:
Patient Recruitment - Patient recruitment costs more and consumes more time than any other aspect of clinical trials. Study sponsors and clinical trial vendors must remain apprised of the latest trends and tools in patient recruitment.
Budgeting and Performance Assessments - Clinical budgets and spending benchmarks are the keys to accurate trial budgeting and planning. Clinical project managers must set clear performance expectations and measure and manage trials to meet those objectives. Timely results from patient recruitment campaigns should inform mid-trial decision-making and resource allocation.
Clinical Operations Structure and Workflow - To avoid major speedbumps, clinical trial management team members must know their roles and responsibilities, and communication with vendors and investigators must be seamless. Clinical affairs executives must weigh the advantages and disadvantages of contrasting approaches to clinical team structures. Knowing where and how to streamline workflow is vital to running a top-notch clinical development group.
Sample Metrics
Accelerating Clinical Trials: Budgets, Patient Recruitment and Productivity contains more than 250 metrics and 60 charts and graphics. Among the metrics and charts included are:
- Clinical trial duration by phase and therapeutic area
- Clinical trial duration beyond planned deadline
- Clinical trial stages by percent of total trial timeline consumed
- Rankings of clinical trial stages according to opportunity to accelerate trials
- Average number of patients and sites by phase
- Patient-per-site ratio by phase
- Average per-patient clinical trial cost by phase and therapeutic area
- 2004 clinical affairs budgets
- 2004 clinical affairs budgets as a percent of R&D spend
- Clinical budget categories by percent of toal budget
- Clinical outsourcing budgets
- Investigator meeting budgets
- Rankings of factors impacting clinical trials cost
- Performance measures used by surveyed companies
- Performance measures' impact on organizational change
- Rankings of patient recruitment referral tools
- Patient recruitment advertising and marketing tools ranked by efficacy
- Patient recruitment incentive rankings
- Investigator recruitment and retention tool rankings
- Web-based patient recruitment rankings
For more information visit http://www.researchandmarkets.com/reports/c9392
Laura Wood
Senior Manager
Research and Markets
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