Successful teams win this race by minimizing risks, eliminating trial unknowns and hitting study deadlines. Supported by ample resources, they build process improvements through performance measurement and charge ahead with new techniques to accelerate trial timelines.
Designed to benefit teams and individuals in any role in the clinical trials space, this study will help teams achieve clinical operations efficiency — and realize the significant payoffs that accompany successful drug development:
* Save time through adaptive trials:
Learn how leading-edge companies use adaptive design to accelerate trials and achieve the desired endpoints. Understand the FDA’s new guidance and get a real sense of where the industry stands on this new frontier.
* Track the right metric at the right time:
Track 26 operational, timeline and resource metrics across the five development stages using realcompany data from 80-plus trials. Learn how to incorporate forecasting software into trial design and planning.
* Benchmark and manage resources:
Break out individual costs and compare per-patient investments across five major therapeutic areas for Phases 1 through 4. Track staffing trends and coordinate in-house and outsourced teams.
Table Of Contents :
Chapter 1: Clinical Trial Costs and Outsourcing
41 charts detailing these points:
* Factors most responsible for increased clinical trial costs
* Average per-patient clinical trial costs across all therapeutic areas — 2008 and 2011
* Average percentage of clinical trial costs outsourced across all therapeutic areas — 2008 and 2011
* Per-patient clinical trial costs, broken down by phase, for these therapeutic areas:
o Cardiovascular
o Oncology
o Central Nervous System
* Average percentage of clinical trial costs outsourced across all therapeutic areas — 2008 and 2011
* Diabetes
* Hematology
Chapter 2: Clinical Trial Staffing Benchmarks
31 charts focus on clinical staffing data, and 5 tables provide staffing figures broken down by phase:
* Total trial staffing by phase
* Overall percentage of staffing outsourced by phase
* Average patients and average sites per CRA, by phase
These metrics are broken down by phase:
* Actual patients/sites per CRA
* Clinical trial staffing and average staffing by position
* Average percentage of FTEs outsourced by phase:
o CRAs/monitors
o Trial managers
o Clinical directors/VPs & TA program supervisors
o Data management
o Medical writing
o Biostatistics/
o Average percentage of regularory FTEs outsourced by phase
o Clinical Quality Assurance (QA)
o Clinical trial supplies
o Chemistry Manufacturing and Controls (CMC)
o Contract management
o Drug safety
Chapter 3: Clinical Trial Performance Metrics
19 charts focused on these clinical development topics:
* Average number of metrics collected by phase
* Prevalence of time, operations and resource metrics collected across all clinical trials and broken down by phase
Time
* Average time to close a database
* Average time to initiate an investigational site
* On-time protocol completion
* Time to completion of clinical trial
* Time from statistical tables complete to clinical trial report complete
* Time from database lock to statistical tables complete
* Time from first patient in (FPI) to last patient out (LPO)
* Time from last patient in (LPI) to last patient out (LPO)
* Time from last patient out (LPO) to database lock
* Time from last patient out (LPO) to statistical tables complete
* Time to randomize a target number of patients
* Time to enroll a target number of patients
Resource
* Overall cost per patient enrolled
* Overall cost per patient randomized
* Cost per clean Clinical Research Form (CRF) page
* Budget to completion of a trial
* Patients per CRA
* Sites per CRA
Operations
* Investigator recruitment rates
* Case report forms collected per CRA per day
* Patient enrollment rates (per site)
* Patient retention rates
* Patient randomization rates (per site)
* Site retention rates
* Advertising/
* Data error rates
Chapter 4: Adaptive Clinical Trials
13 charts focusing on adaptive design:
* Percentage of companies using adaptive design in clinical trials
* Rating adaptive clinical trials design effectiveness versus traditional clinical trials design
* Percentage of adaptive design usage in clinical trials by development stage
* Likelihood of adaptive design usage in clinical trials by development stage
* Impact of adaptive design usage in clinical trials on trial cost, aggregate and by company
* Impact of adaptive design usage in clinical trials on trial duration, aggregate and by company
* Importance of factors for using adaptive design in clinical trials
* Percentage of companies that unblind data during interim analyses in adaptive clinical trial designs
* Percentage of companies using third party or DMC during interim analyses in adaptive clinical trial designs
* Prevalence of usage of adaptive design types, aggregate and by company
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