Danielle Sheard and Sara Steeves, Costello Medical, Cambridge, UK
Strategic Publication Planning
A comprehensive understanding of the clinical data and scientific literature in a therapeutic area underpins publication planning. Gap analysis is one long-standing publication planning tool that can be used for this purpose, but what makes a good gap analysis?
Gap analysis involves appraisal of the scientific literature to identify topics that have been covered extensively in the literature or, conversely, have been covered in limited detail or not at all. Conducting an effective gap analysis requires a significant amount of resource, so the publication planning team should consider whether the investment is worthwhile. This approach is particularly useful in situations in which there are several competitor products, or if the company is unfamiliar with a new therapeutic area. If planned and conducted effectively, gap analysis provides a comprehensive overview of the disease area, identifies relevant target journals, highlights competitor strategies, and flags any areas of unmet medical need. The publications team can then use this information to develop strong, consistent communication points that address true evidence gaps.
Framing the Analysis
The publications team members should have a clear view of the topics they would like to assess, as well as the process they will use to do so (see Figure 1 below). While it can be tempting to begin with a literature review and identify gaps or publication clusters along the way, prospectively defining topics that would be valuable to assess helps to ensure that the literature review is designed to evaluate those topics, and that any gaps identified aren’t simply a result of misalignment of the literature review scope.
The output of an initial SWOT analysis is an ideal starting point. This technique is widely used in business as a strategic planning tool, and outlines Strengths, Weaknesses, Opportunities, and Threats. The team is likely to have a good understanding of the strengths and weaknesses of the product itself, but the perceived opportunities and threats in the wider marketplace can be identified through gap analysis.
The publications manager can consider the potential topics in terms of key communication points and the topics they relate to, as well as how these topics have been covered, before presenting their recommendations to the publications team. Key considerations are:
- general publication area (clinical trial data, health economics and outcomes research [HEOR], epidemiology)
- publication type (eg, conference presentation vs. peer-reviewed journal article, primary study vs. review article)
- journal and audience (eg, specialist or generalist journal)
- date of publication
- authorship
The definition of what constitutes a “gap” will vary depending on the objectives; it could be as simple as any area in which no publications were identified, or it could be more complex, factoring in study evidence level, study and publication quality, and consensus among publications as examples.
Figure 1. Overview of gap analysis process
Collecting the Evidence
After defining topics of interest, a literature review should be carried out to identify the degree to which publications exist in these areas. In an ideal world, relevant publications would be identified through a broad, systematic literature review to minimize the risk that “gaps” identified are a result of limitations in how the review was carried out. In practice, however, time and resource constraints may mean that a focused or targeted literature review is more feasible. Targeted review approaches can include reducing the number of literature sources that are searched, using less comprehensive search strategies, and/or limiting the review of each article to a single individual (as opposed to independent review by two separate reviewers, as is typically done in systematic reviews). If taking a targeted approach, limitations of the review should be considered when mapping the identified literature, and the results considered indicative rather than definitive. If required, validation exercises can be undertaken to confirm the gaps are genuine; for example, through further targeted searches or seeking the opinion of experts in the field of interest.
Regardless of the review approach, the search strategy used to identify publications and the eligibility criteria through which reviewers determine whether a publication is to be included should be specified upfront to help ensure the review matches the gap analysis objectives. The PICO framework is commonly used for this purpose, encouraging reviewers to incorporate the study Population, Interventions, Comparators, and Outcomes into the definition of “relevance.” This can be supplemented with additional facets, such as study design, publication type, publication date range, and publication language.
Through the course of the review, relevant articles should be documented, and information relevant to the gap analysis extracted. At a minimum, all factors used to define topics (eg, message, product, publication type) should be captured from relevant articles, plus recording additional information (eg, study objectives, study design, primary outcome, etc.) can help to provide context when interpreting the review findings, even if not formally included in the final evidence map. A quality assessment of each included article can be performed using an appropriate tool or checklist, to add further depth to the gap assessment.
Building the Map
After reviewing the available literature, publications should be mapped against each pre-specified topic. Figure 2 below illustrates an example evidence map in which publications have been stratified by the product they relate to, the message they convey, and the publication type (eg, peer-reviewed full journal publications versus conference presentations or other grey literature).
In this example, the evidence map suggests that there are some differences in focus between products; for instance, Product A has a major focus on Message A in contrast to Product D which focuses on Message B, and there is generally poorer coverage of Message A compared to the other messages. The mapping exercise should be repeated with any other factors considered in the review; for example, stratifying article messages by journal, target audience, publication year, and so on to build a comprehensive picture of where gaps exist.
Figure 2. Example evidence map
SWOT Analysis Review
Returning to the SWOT analysis, gaps revealed by the evidence map can feed into Opportunities, while publication clusters where it is clear a competitor is targeting a specific message may be added under Threats. From here, cross-SWOT analysis – a systematic comparison of Strengths against Opportunities, Weaknesses against Threats, and vice versa – helps to narrow down which data to focus on (see Figure 3 below). By looking at where expected or available data for a product directly align with an opportunity (eg, a lack of publications on similar data) or a threat (eg, extensive publication by a competitor on similar data), it may be possible to narrow down which data would be strategically advantageous to prioritize for publication. On the other hand, a review of gaps in the product data against publications from competitors can help identify areas of priority for data generation activities.
It is important to note that assessment of publication and data gaps by this method is just the starting point for the development of the publications plan. It is equally important to factor in the timeframe required to make data available for publication, since faster time to publication may outweigh the priorities suggested simply by considering alignment with gaps. In addition, this exercise may identify areas of unmet medical need that are not covered within the literature, which may be addressed through other types of publications, such as review manuscripts.
Figure 3. SWOT analysis
Summary – What Makes a Good Gap Analysis?
- A gap analysis must be well-planned to be effective, so companies should decide whether the investment is worthwhile and then ensure the necessary time and resources are put aside at the beginning of the process.
- Prospectively defining topics of interest will inform the search strategy for the review and ensure that real literature gaps are identified.
- A SWOT analysis can be used to structure publication planning discussions; it narrows down key communication points of interest and facilitates prioritization of publications once gaps have been identified.
- Useful information from relevant articles should be documented; for example, key messages, product, publication type, study outcomes, journal, and authorship.
- Matching identified publications to pre-specified topics creates an evidence map that can be used to assess which key communication points competitors are focusing on.