Late Phase (Phase IV)

Beyond registration: The essential role of late-phase research

Streamline and optimize your next study

Registration research is required by regulators and deals exclusively with safety and efficacy. Late-phase research is, for the most part, voluntary: Sponsors choose to do it to develop information that will allow them to add new indications to the label, optimize treatment guidelines, find competitive advantages, and develop rationales that will win over physicians, patients, advocacy groups, insurers, and, of course, Medicare and Medicaid.

In addition, regulators are demanding more information about hidden safety issues that emerge only after repeated real-world product usage by large, diverse populations over long periods of time. That, too, is a critical objective of late-phase research.

Design flexibility
Unlike registration research, late-phase research can cover a wide spectrum of designs, from observational or interventional studies to retrospective studies that analyze existing data. In observational registries, investigators observe real-world treatment and outcomes over time of numerous patients who have the same disease (a disease registry) and/or are receiving the same treatment (a product registry). Registries also can be described as prospective open-label observational studies.

Registries can provide valuable data on the natural history of a disease, the clinical or cost-effectiveness of a particular therapeutic approach, resource utilization, safety issues and adverse events, quality of life, patient compliance, and outcomes.

Observational registries: Strategies for success

Premier Research has extensive experience managing these critical factors for success:

  • Clearly defining the scientific objectives and other parameters of the study.
  • Determining the study size based on the desired precision of effect estimates, feasibility, cost, and whether the registry is intended to support regulatory decision-making.
  • Selecting the proper distribution of sites for accurate patient representation. (The study population should approximate the target population as closely as possible.)
  • Developing and implementing strategies for patient recruitment and long-term retention.
  • Building and sustaining community development using multi-level digital and social media strategies.
  • Collecting, verifying, and validating data to ensure registry integrity and interim analysis.
  • Using call centers to take patient calls and enter data into the eCRF. This provides real-time data and relieves sites from the burden of data collection, enabling them to focus on study assessments.
  • Optimizing site management through remote and risk-based monitoring.

Premier Research provides a full range of services for all types of late-phase studies, from study planning, logistics, and recruitment to site management and data processing and evaluation — a critical issue due to the massive volumes of data developed in large-scale late-phase studies.

We can help you simultaneously streamline and optimize the value of your next late-phase study.

Late-phase services

  • Ongoing pharmacovigilance studies
  • Risk management
  • Comparative effectiveness research
  • Observational (non-interventional) studies
  • Health economics research
  • Patient and disease registries
  • Health-related quality-of-life studies
  • Pharmacoepidemiology
  • Expanded-access programs

Potential benefits of late-phase studies

  • Generate knowledge and evidence that appeal to payers, patients, and physicians.
  • Demonstrate effectiveness or comparative effectiveness in different populations.
  • Meet post-marketing commitments.
  • Generate evidentiary requirements for coverage.
  • Meet regulators’ demands to monitor long-term safety and safety in different populations.
  • Manage risks and benefits.
  • Generate data for new indications or label extensions.
  • Obtain or expand market access.
  • Change behavior.
  • Improve quality of care.
  • Prove product value through economic or quality-of-life benefits.
  • Bring scientific information to stakeholders sooner.
  • Enhance the practice of personalized medicine.
  • Understand the natural history of disease and treatment.
  • Generate evidence for product differentiation and positioning.
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