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Real World Evidence

Real-World Evidence Synthesis, Study Design, and Database Analysis

Real-world evidence is used to address information gaps throughout the product lifecycle, from development through launch and commercial growth into the mature stage; real-world evidence can address research questions that are difficult to answer using data from a randomized controlled trial, such as long-term clinical effectiveness and safety, prescribing patterns, patient-centered outcomes, and cost impact. External influencers and modifiers like price reviews, reimbursement assessments, new competition, generic market entries, and new indications require a nimble and proactive RWE approach to continue commercial success. Evidence needs are increasingly more demanding and cover a wide range of topics:

  • Understand standard of care
  • Unmet needs/disease burden
  • Patient recruitment
  • Trial design
  • Adherence
  • Utilization and prescribing
  • Long-term clinical outcomes
  • Head-to-head comparative effectiveness
  • Differentiation in sub-populations
  • Target populations
  • Usage difference
  • Effect of switching on outcomes
  • Differentiation vs. generic
  • Post-launch commitments to regulatory authorities

The impact of real-world evidence is becoming tangible across the spectrum of stakeholders:

  • Regulators use real-world evidence to inform label expansion decisions and for post-market safety surveillance.
  • Payers have used real-world evidence to inform pricing assessments when making reimbursement decisions.
  • Manufacturers use real-world evidence to provide scientific insight on the effectiveness and safety.
  • Physicians may increase their use of a product based on real-world evidence.


  • Biliary Tract Carcinoma
  • Breast Cancer
  • Urothelial Cancer
  • Glioblastoma
  • Adjuvant supportive therapies (CINV)
  • Prostate cancer
  • Lung Cancer (NSCLC, SCLC)
  • Gastric Cancer
  • Head and Neck Cancer
  • Melanoma
  • Hodgkin Lymphoma
  • Renal Cell Carcinoma
  • Hematological Cancers (CLL, CML, AML, MM)
  • Hepatocellular Carcinoma (HCC)
  • Colorectal Carcinoma (CRC)

Other Disease States

  • Epilepsy
  • Multiple Sclerosis
  • Inflammatory Bowel Disease (IBD)
  • Direct Oral Anticoagulants (DOACs)
  • Glaucoma
  • Sleeping Disorder Treatments
  • Mental Health Disorders
Retrospective Database Studies
  • Protocol development
  • Results Interpretation and dissemination strategies
Areas of expertise include
  • Disease burden
  • Healthcare resource utilization
  • Treatment patterns
  • Adherence/persistence
  • Comparative effectiveness
Market Insights
  • Payer insights
  • Provider insights
  • Patient Insights

Our approach

  1. Insight development: knowledge synthesis from payers, HTAs, affiliates, and regulators via primary and secondary research, aligned to medical, HEOR, market access, and marketing objectives
  2. Real-world data source evaluations: understand elements available and best resources and methods to collect necessary data
  3. Research approach and elaboration: evaluate time, cost, and strength of evidence for each possible approach
  4. Evidence generation and analysis: data sourcing and analysis according to a peer-reviewed analysis plan
  5. Evidence dissemination: data sourcing and analysis according to a peer-reviewed analysis plan