Regulatory Research

External Control Arms for Timely Drug Approvals

ConcertAI’s deep, custom abstraction of patient real-world data and decades of scientific expertise helps clients through the regulatory process of designing and submitting successful External Control Arms.

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Regulatory Grade
Regulatory-Grade
Linked Claims, Genomics Datasets
Linked Claims, Genomics Datasets
Full-Service Consultation
Full-Service Consultation
Custom Abstraction of Specific Variables
Custom Abstraction of Specific Variables

Reasons for
External Control Arms

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Rare Cancers

Identify patients with rare solid tumors or hematologic malignancies

Competitive Trial Space

Limit susceptibility to competitive trial recruitment by leveraging retrospective samples

Patient Criteria

Oversample critical subgroups of interest for deeper analyses

Trial Completion

Find, recruit, and analyze control patients in months rather than years

INFOGRAPHIC: EXTERNAL CONTROL ARMS CAN BRING LIFE-SAVING CANCER DRUGS TO MARKET FASTER

Clinical Trial Challenges

Clinical trials are expensive and challenging in ordinary times. COVID-19 has made this situation much more difficult, negatively impacting clinical trial activities and delaying life-saving treatments. In response, the FDA has acted recently to create an environment to encourages novel trial designs where external control arms can thrive.

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Clinical Trial Challenges
EXTERNAL CONTROL ARMS

In-Depth, Regulatory-Grade RWD and Scientific Expertise

  • Pre-Approval
  • Post-Approval
  • Inform clinical trial design and feasibility with our interactive cohort matching tool
  • Conduct propensity score matching or frequency matching with demographic and clinical characteristics matched to clinical trial patients
  • Rescue underperforming trials when the RCT is having difficultly accruing patients in a standard of care cohort
  • Satisfy market requirements for fast-tracked, breakthrough applications or newly approved treatments coming to market with limited comparative data
  • Fulfill post-authorization safety assessments, surveillance, and/or efficacy evaluations required by regulators
  • Conduct studies for label expansion and new indications
  • Find new dosing schedules and routes of administration
  • Dynamically track the ECA cohort from diagnosis through discharge, end of record, or death
  • Generate persuasive comparative evidence to demonstrate product value
INFOGRAPHIC: EXTERNAL CONTROL ARMS CAN BRING LIFE-SAVING CANCER DRUGS TO MARKET FASTER

Novel Study Designs

External control arms use real-world data (RWD) to enhance data from single-arm trials. They can speed up patient accrual and reduce costs. Results include:

  • 50% reduction in patient accrual needs
  • Ability meet fast-tracked designation timelines
  • Increased trial efficiency
  • Reduced site and patient burden
  • Decreased risk
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Novel Study Designs
EXTERNAL CONTROL ARMS

Working with a one-stop partner for deep, reliable RWD and expert research and analytics services can lead to:

Timely Treatment Assessments
Timely Treatment Assessments
Faster Drug Approvals
Faster Drug Approvals
Reduced Site and Patient Burden
Reduced Site and Patient Burden

Customer Value for External Control Arms

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Clinical Development Leaders

Rapidly generate insights into standard of care and areas of unmet need with access to thousands of on-demand and custom abstracted data elements

HEOR, Market Access and Medical Affairs Executives

Leverage RWD for post-marketing analyses, comparative effectiveness analyses, and reimbursement submission needs for new indications/label expansions

Epidemiologists

Understand patient and disease characteristics

Translational Medicine Leaders

Evaluate the performance of existing therapies and identify risk factors associated with poor outcomes