Glossary of terms

Accelerated approval is a regulatory route that permits earlier product availability for treatments targeting serious diseases and meeting an unmet medical need by relying on surrogate measures.

The addressable population is the group of patients within a larger disease setting who satisfy defined criteria for receiving a particular product or intervention.

An advisory board is an organized session in which external experts share insights to guide strategic, clinical, or scientific decisions in pharmaceutical development.

Artificial intelligence (AI) refers to computer systems built to carry out tasks that normally require human intelligence, including learning, reasoning, and making decisions.

An asset evaluation determines the appeal, market potential, and probability of success for either an internal or external asset.

Attribution refers to the act of connecting a scientific, clinical, or strategic outcome to a defined source, action, or stakeholder, supporting transparency and traceability.

Benefit-risk assessment is the structured review of a treatment’s therapeutic benefits compared with its potential risks, helping guide regulatory and clinical decisions.

Bibliometric analysis is the use of statistical methods to examine and interpret publication data.

Bibliometrics refers to the quantitative study of academic publications used to assess research performance and impact.

A biosimilar is a biological medicine that is highly comparable to an approved reference biologic, showing no clinically meaningful differences in safety, purity, or efficacy.

In market access and regulatory settings, burden of proof refers to the requirement for pharmaceutical companies to show the value, efficacy, and safety of their products to key stakeholders.

Channel strategy refers to how pharmaceutical companies use distinct communication and access routes to engage key stakeholders across medical, payer, and patient channels.

Clinical benefit refers to the positive effect a treatment has on patient health, including symptom relief, disease alteration, or improved survival.

Clinical development is the systematic process of evaluating a new medical intervention in humans to determine its safety and efficacy.

Clinical differentiation is the extent to which a product distinguishes itself from alternatives based on its therapeutic profile, safety, or usability.

The clinical landscape refers to the current state of clinical development within a specific disease area, covering ongoing and completed trials, treatment practices, and emerging standards of care.

Clinical meaningfulness describes the real-world importance of a treatment’s effects on outcomes that matter to patients, providers, and payers.

Co-author impact factor is a calculated metric that measures the influence of an author’s collaborators by examining their publication activity and citation records.

A collaboration network is a visual or analytical depiction of co-authorship and institutional connections within scientific research communities.

The processes through which a drug transitions from approval to real-world use. This includes launch, distribution, pricing and reimbursement, stakeholder engagement, and lifecycle management.

Comparative effectiveness assesses how a treatment performs compared with other available options in terms of efficacy, safety, and real-world outcomes.

The competitive landscape refers to the current mix of products, companies, and strategies competing within a defined therapeutic area, market, or indication.

Conference planning is the strategic organisation of a pharmaceutical company’s activities before, during, and after a scientific or medical meeting to enhance scientific impact and stakeholder engagement.

Consultative bodies are advisory organisations that an HTA body is required by law or policy to consult or consider recommendations from. They may operate as a subgroup within the HTA body or as an independent organisation. They are not payers, as they do not make final reimbursement decisions.

The digital opinion leader (DOL) impact factor is a proprietary bibliometric-based metric used to identify and rank DOLs.

A decentralized clinical trial (DCT) is a study that employs digital tools and remote methods to lessen or remove the need for in-person site visits.

A development pipeline is the collection of drug candidates that a pharmaceutical company (or the broader industry) has in discovery or development at any given time.

Digital activity refers to the online engagement of stakeholders across channels such as social media, webinars, and virtual conferences, offering insights into their interests, influence, and networks.

The digital landscape refers to the mix of online platforms, behaviours, and content that shape scientific dialogue, stakeholder engagement, and perception within a therapeutic area.

Digital landscaping is the structured review of online activity used to identify key stakeholders, emerging trends, and scientific discussions within a therapeutic area.

Digital listening is the ongoing monitoring and analysis of online conversations to capture insights on stakeholder views, emerging topics, and perceptions of scientific data.

A DOL is an influential individual or organisation with a substantial online presence, often on social media, within the healthcare or pharmaceutical industry.

Digital transformation is the integration of digital technologies into core pharmaceutical operations to improve scientific, clinical, and commercial performance.

Disease burden refers to the overall impact of a health condition on individuals, healthcare systems, and society, spanning clinical, economic, and quality of life effects.

Disease severity refers to the degree or intensity of a condition’s effect on a patient’s health, daily functioning, and quality of life.

Dose optimization is the process of determining the most effective and safe drug dose for a defined patient population.

An early access program (EAP) enables patients with serious or life threatening conditions to obtain investigational therapies before full regulatory approval.

Economic modeling involves applying mathematical frameworks to estimate the cost effectiveness, budget impact, or overall value of healthcare interventions.

Eligibility criteria are the inclusion and exclusion rules that specify which participants may enroll in a clinical trial.

Engagement planning is the strategic design of how and when to engage external stakeholders to support scientific, clinical, and commercial goals.

Epidemiology is the study of the distribution, patterns, and determinants of health within defined populations.

An evidence hierarchy is a tiered framework that ranks types of evidence according to their methodological strength and reliability.

An evidence generation program is a coordinated plan for producing clinical, real world, and economic data to support the value and positioning of a pharmaceutical product.

An external control arm uses data from outside a clinical trial to act as a comparator for assessing a treatment’s effectiveness.

Feasibility planning is the process of assessing whether a clinical trial or development strategy can be successfully carried out based on operational, scientific, and market factors.

First author refers to the individual credited with leading the design, execution, and writing of a scientific publication.

Formulary inclusion is the decision by a healthcare payer or institution to list a pharmaceutical product as an approved treatment option.

Gap analysis is the process of identifying missing evidence, insights, or capabilities required to meet strategic, regulatory, or stakeholder expectations.