Late Phase Focus

What are Late Phase Studies?

At REGISTRAT-MAPI, we develop partnerships with our biopharmaceutical and medical device company clients by providing strategic solutions to optimally design and implement registries, Phase IV, and other Late Phase studies. Late Phase or Peri-approval studies are conducted prior to product approval (Phase IIIb) and following product launch (Phase IV) to demonstrate product effectiveness, safety, and acceptance. Although generally not randomized or controlled, Late Phase studies are conducted with the same regulatory and data quality standards as registration trials. As a result, analyses and publications generated from these validated data add insight to the real-world use of a product or demonstrate evolving practice patterns.

Late Phase studies direct future product development, manage risk, and provide commercial opportunities. Increasingly, the FDA is granting product approval on a conditional basis-estimated to be 75-80% of new chemical entities-requiring that a Sponsor conduct post-approval surveillance of the product. As a result, long-term tracking of patients in a real-world clinical setting provides valuable ongoing safety information for risk management. Additionally, Late Phase studies can target particular therapeutic areas or populations where relevant clinical data are required to ascertain the effectiveness and utilization patterns of a product. Managed care organizations, healthcare providers, and consumers all have an interest in obtaining real-world clinical, economic, and humanistic outcomes data to improve the quality of patient care.

A Late Phase study is an integral component of the commercialization effort for a product because it impacts multiple aspects of ongoing clinical and commercial support. A program such as a product registry is a systematic effort that encompasses and integrates the perspectives and objectives of Clinical, Safety, Marketing, Sales, Regulatory, and Legal in the commercialization process.

Types of Late Phase Studies

  • Phase IIIB Study-completion of registration studies / safety / experience
  • Phase IV Study-comparative / label extension
  • Product registries
  • Disease registries
  • Pregnancy registries
  • Pharmacoepidemiologic studies
  • Post-marketing safety surveillance
  • Large Simple Safety Studies (LSSS)
  • Risk Management Programs (RMP)
  • Clinical experience trials
  • Patient Reported Outcomes (PRO)
  • Health economic outcomes
  • Compliance / adherence
  • Medical / Product utilization
  • Expanded Access Programs (EAP)

Value of Late Phase Studies

  • Generate clinical effectiveness data
  • Support & strengthen the product safety profile
  • Provide "real-world" clinical, economic, humanistic outcomes
  • Provide a supportive environment for treating physicians
  • Impact quality of patient care
  • Develop "best practice" guidelines, and standards of care
  • Generate hypotheses
  • Develop sub-studies
  • Provide data for abstracts, manuscripts, and society meetings
  • Integrate Clinical, Safety, Marketing, Sales, Legal, and Regulatory in the commercialization process
  • Provide a value-added service & demonstrate responsiveness to customers
  • Demonstrate a commitment to:
    • Patient care
    • Quality improvement
    • Education of healthcare providers
  • Accelerate product adoption to achieve rapid peak sales & maximize product potential
  • Identify under-treated patient populations
  • Characterize evolving treatment patterns
  • Influence market expansion & product penetration
  • Promote product retention & compliance
  • Identify factors impacting prescribing decisions
  • Identify issues related to product use
  • Generate clinical data on a product to drive market leadership
  • Characterize unsolicited off-label product use
  • Evaluate data to develop targeted sales & marketing strategies
  • Use objective data to drive product life cycle planning
  • Obtain competitive intelligence on other manufacturers' products
  • Maximize communication opportunities with key customers