What is a systematic literature review (SLR)?
A systematic literature review (SLR) is a type of study in which a search of the published literature is conducted using a pre-specified and structured approach. They are a good way to get an understanding of what evidence is currently available on a specific question or topic and in turn can be used to inform understanding of key data gaps. They can also be the first step in collating studies that can then be used in meta-analyses.
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What is Good Publication Practice (GPP)?
Good Publication Practice (GPP) is a guidance that many pharma companies adhere to in setting their publication policies for research conducted by the corporation. The guidance is created by the International Society for Medical Publication Professionals (ISMPP) and it contains best practices on a wide range of publication-related topics including the appropriate role of authors and other supportive team members (such as those providing medial writing support), how to appropriately give credit to various team members, advice on best policies on payment to authors, clarity around authorship criteria as published by the International Committee of Medical Journal Editors (ICJME), and so on.
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What is a Non-Interventional Study?
A non-interventional study (NIS) is a broad term that includes any type of research in which patients are treated as they otherwise would in the real world. This can include retrospective studies utilizing sources such as patient charts, electronic health record data, administrative claims data, or patient registries as well as prospective registries that do not have an interventional component. Typically, the term NIS (or NIR for non-interventional research) is used to describe studies of medical or clinical nature and not market research.
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What is minimal clinically important difference (MCID)?
The minimal clinically important difference (MCID) is a threshold which needs to be met for a given intervention compared to standard of care in order to consider it of clinical relevance. The bar for MCID may be higher than that for statistical significance (although this is not necessary) and if so, a statistically significant result may still be considered not meaningful from a clinical perspective because it is not moving the needle enough for patients.
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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.
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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.
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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.
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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.
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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.
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What is Real World Evidence?
Real world evidence (RWE) refers to evidence from data sources with greater generalizability than that which is typically gained from phase I-III clinical trials. The most common form of RWE is observational studies of retrospective data such as electronic health records (EHR) or administrative claims data (such as Truven Marketscan or Optum Clinformatics). Randomized forms of RWE include pragmatic clinical trials which typically have more relaxed inclusion and exclusion criteria compared to registration trials and thus include a more heterogeneous population.
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