Adaptive Design Clinical Trials

Adaptive Design Clinical Trials

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This report provides benchmarks for adaptive trial design, including qualitative and quantitative metrics that examine companies’ use of adaptive trial designs, how these designs may affect clinical team responsibilities, and how to create strategies associated with adaptive design clinical trials.

  • Better understand the current applications of, advantages and limitations of adaptive trial design use. Many life science teams are still getting comfortable with incorporating adaptive trial designs in their clinical research.
    • Increase odds of a successful candidate reaching late-stage development. Adaptive design can reduce the number of ineffective products that make it to Phase 3. This benefit allows teams to better manage resources and the product pipeline. If used correctly and backed by strong planning, adaptive trial design can save time and money.
    • Adaptive design is better suited for some patient populations and therapeutic areas than others.
  • Use this report’s resource and structure benchmarks — as well as team profiles and best practices — to strategically inform adaptive trial design planning and execution.
    • Interviewed executives have found that no amount of resources can replace poor planning.
  • Description
  • Additional information

Report Details 

This report explores adaptive design clinical trials. An adaptive trial allows teams to prospectively plan adjustments to clinical trial parameters (such as patient sample size and dosing arms) ahead of clinical trial start-up. Teams can implement these plans as studies progress.

  • Number of graphics: 91
  • Data splits:
  • Company size:
    • Top 10
    • Top 50
    • Small
    • Biotech
    • Device/Diagnostic
  • Therapeutic area:
    • Autoimmune
    • Diabetes (Type 2)
    • Cardiovascular
    • Cardio and Thrombosis
    • CNS
    • Hematology
    • Immunology
    • Infectious Diseases
    • Inflammation
    • Nephrology
    • Neurology
    • Non-Surgical Devices
    • Oncology
    • Rheumatology
    • Surgical Devices

Data highlights include:

  • Sponsor organization executives’ perspectives on potential benefits and challenges of adaptive trial design.
  • Benchmarks showing current (2015) ratios of adaptive to non-adaptive studies across 11 therapeutic areas (for surveyed companies).
  • Metrics tracking level of involvement in adaptive trial design from 11 functions companywide, as well as CROs/vendors.
  • Cost-per-patient benchmarks for early- and late-stage adaptive and non-adaptive trials across 9 selected adaptive design types.
  • Ratings of specific adaptive trial design planning and execution challenges
  • 12 profiles showing how real teams across the life sciences (pharma, biotech, device and diagnostic) are using adaptive design.
    • Where available, profiles contain information regarding:
      • Company type and team scope of responsibility
      • Target therapeutic area
      • Number of total trials in target therapeutic area versus number of trials with adaptive design elements
      • Specific adaption(s) used, by development stage
      • Estimated time saved by using specific adaptive trial types, by development stage (in months)
      • Per-patient cost of specific adaptive trial types, by development stage (in USD)
      • Number of key staffing roles necessary to support specific adaptive trial types, by trial development stage
    • Three key recommendations and findings based on these profiles’ data.
REPORT FEATURES:

Strategically plan and execute adaptive design clinical trials: Although simple adaptive trial applications during early-stage clinical research are growing somewhat familiar, regulatory agencies are less well-versed in more complex study designs. The data and qualitative analysis in this study provide necessary steps toward planning successful adaptive trials. It also analyzes which development phase and adaption types that clinical development teams prefer.

REASONS TO BUY:

Increase your odds of success in Phase 3 trials by implementing a well-researched adaptive design plan during early research stages: Employing adaptive design clinical trials may require companies to develop specialized groups or to conduct outside research to help familiarize teams with this study methodology. Proper trial planning and execution does not necessarily require additional resources, but rather prioritizing adaptive plans over other needs. This study includes detailed best practices, insights and strategies for expanding adaptive design clinical trials through structure and planning. It also includes adaptive trial design profiles which provide real-life examples of planned adaptations within specific therapeutic areas.

TARGET AUDIENCE:

Cull the number of inappropriate candidates that reach Phase 3 by implementing a “drop-the-loser” approach: Pharmaceutical companies that use “drop-the-loser” approaches to study design can potentially conserve several months of planned study time and pay less per patient when using planned adaptions. This study explores how pharmaceutical and biotech companies are using these studies — and their results compared to non-adaptive phase 1 trials.

CHAPTER EXAMPLE:

Adaptive trial designs have remained an ongoing topic of discussion for regulators and life science teams over the past decade. Broadly, adaptive trial designs enable clinical project teams to prospectively plan adjustments to clinical trial parameters such as patient sample size and number of clinical dosing arms. Adaptive trials may incorporate stopping rules that allow companies to discontinue clinical research based on a demonstrated lack of product efficacy. Alternately, studies may incorporate allocation rules that shift study participants from unsuccessful trial arms to more successful ones.