Top 10 Reasons to Conduct Late Phase Research

Top 10 Reasons to Conduct Late Phase Research

Manufacturers of pharmaceutical or biotech products or medical devices understand that the regulatory approval of their product is not the final hurdle.  Instead, it’s the beginning of a new set of challenges, requiring strategic and innovative postapproval solutions related to product safety and demonstration of value and effectiveness.

The healthcare industry continues to face increasing pressures to deliver more robust data and information to key stakeholders, including healthcare providers, regulatory agencies, payors, and most importantly, patients.  Biopharmaceutical and medical device companies must navigate an evolving landscape.  Evidence requirements must be well understood, and a strategic evidence gathering plan must be in place.  In the context of increasing evidence requirements and limited research and development dollars, synergistic cost and time-efficient studies spanning the product lifecycle must be designed and executed to meet these challenges. 

UBC has compiled our own Top 10 list of reasons to conduct late phase research with the aim of demonstrating product value

  1. Real-world value:  Observe and document real-world effectiveness outside of the clinical trial environment. 
  2. Comparative effectiveness: Determine how a product (drug, biologic, device, diagnostic) compares with the “standard of care,” or with other competitors’ products,  in the usual care environment.
  3. Patient-reported outcomes: Evaluate patient (and/or caregiver) reported outcomes, including health-related quality of life impacts of diseases and treatments, patient and caregiver satisfaction, and adherence and other patient-centric data, to inform or support market access.
  4. Cost Implications: Collect resource utilization and other relevant data to quantify the burden of illness and economic impact of disease and how savings may be realized through alternative therapies.  Measure and assess the differential economic impact of a novel product versus an alternative intervention or other healthcare service.
  5. Prescriber and/or patient preference: Identify the decision-making process related to reasons why prescribers and/or patients prefer certain treatment characteristics and why patients adhere (or not!) to prescribed medications.
  6. Safety: Gather data on the adverse effects of a product versus other standard of care treatments as they are used in real-world populations.
  7. Disease and patient heterogeneity: Understand how conditions, including orphan diseases, vary in terms of presentation and progression over time.  Patients treated in actual clinical practice are considerably more varied than those included in clinical trials.
  8. Health services research: Understand the impact that health systems, plans, and provider organizations have on the delivery and outcomes of healthcare.
  9. Practice patterns: Document practice patterns of physicians and other healthcare providers – how they may differ by health system, provider, and patient characteristics, and how they may compare to national or international norms or guidelines.
  10. Longitudinal outcomes: Lengthen the duration of follow-up to better understand the consequences of a product, including effectiveness and safety, cost and patient-reported outcomes; or to evaluate outcomes with long latency.

To learn more about how late phase research can help prove the ongoing value of your product, please contac contact us.