Medical R&D

Post hoc analysis

What is a Post Hoc Analysis?
A post hoc analysis is any analysis of a dataset that was not pre-specified prior to data collection. In pharma, it is most often used in the context of clinical trials and refers to analyses which were not specified in the original statistical analysis plan. Post hoc analyses may look at subgroups of interest or different endpoints than those in the primary analyses.

Post hoc analyses are often conducted following primary result communication and publication of clinical trials, especially pivotal studies. They can be a way of better understanding the trial results and population, although caution should be used given the higher potential for bias and cherry-picking once the broader results are known.


Investigator Sponsored Study (ISS)

What is an Investigator Sponsored Study (ISS)?
An investigator sponsored study (ISS) is a study that is initiated and conducted by an external researcher who is not an employee of the pharma company which only funds it. Medical teams usually have a portal or some mechanism through which potential researchers can submit proposals for ISSs that are then reviewed by Medical and R&D teams and may or may not be funded depending on feasibility, strategic rationale, and budget. ISSs are usually conducted with the intent of only furthering the science around a drug and not for inclusion in drug labels.

Market Access Medical

Health Outcomes Liaisons

What are Health Outcomes Liaisons?

Health Outcomes Liaisons are field-based medical professionals who call on payer customers including managed care, pharmacy benefit managers (PBMs), health plans, integrated delivery networks (IDNs), and other population-level decision-makers.

Similar to medical science liaisons, outcomes liaisons are medically trained professionals often with advanced degrees. They can speak to off-label material in a similar manner to MSLs. Instead of providers, however, they are addressing questions and providing information to payers. Beyond general medical content, this includes health economic information such as information on budget impact, cost-effectiveness, and questions around potential patient population size.

Each outcomes liaison usually calls on a set of payers -this may include a region of smaller plans or national accounts such as CVS, Express Scripts, United Healthcare and government accounts like state Medicaid and the Veteran’s Affairs health system.

Outcomes liaisons work closely with in-house health economics and outcomes research teams and market access account executives in defining their strategies for communication with payer customers and for plan-specific action plans.

Outcomes liaisons may be called a variety of names across companies including Managed Care Liasions, Health Outcomes Directors, and Medical Value Liasions.


Independent Medical Education

What is Independent Medical Education (IME)?

Independent medical education is professional education offered to providers at medical congresses or online. Content has to follow guidelines set forth by relevant accreditation bodies such as the Accreditation Council for Continuing Medical Education.

Pharma companies often provide grants to educational providers for development of such courses in areas of interest. The developed content is not reviewed by the company and is not considered to be promotional in nature.

Dedicated personnel in the Medical Affairs group typically set and execute the independent medical education strategy, often looking to include key congresses and have sufficient online offerings as well. IME can constitute a significant part of the medical affairs budget for some brands.


KOL Mapping

What is KOL Mapping?

KOL (key opinion leader) mapping refers to an exercise by which experts are identified and categorized according to their stature in the community, track record with publications and other work, and spheres of influence. It can help in identifying the right physicians to call on for medical field teams, potential experts for advisory boards, and potential collaborators for clinical or other studies.

KOL mapping within pharma often refers to an exercise to identify medical KOLs, but there are experts in other areas for which similar exercises can be completed, including health economics and outcomes research.