Evidence Development

The identification of evidence to support the value of a product, and the appropriate, strategic use of this information, forms the cornerstone of evidence-based medicine. Our dedicated team, led by Saoirse Leonard, has extensive experience across a variety of literature searching methodologies for diverse purposes. Our expertise ranges from systematic reviews of electronic databases to inform HTA submissions, to competitor landscaping and gap analysis activities based on reviews of non-standard evidence sources, such as press releases and pharmaceutical industry news sites.

What Sets Evidence Development at Costello Medical Apart?

  • Provision of strategic advice. From the outset of project design, we work closely with our clients to ensure that our literature reviews meet their evidence requirements while also being delivered within budget. We are happy to advise clients when a more pragmatic approach to a full systematic review could be suitable. On completing evidence searches, we provide strategic interpretation of the results, placing our findings in context with the project’s objectives.
  • Rigorous methodologies. We pride ourselves on our ability to conform to the most rigorous systematic review methodologies, and always conduct our clinical, quality of life and economic reviews for HTA submissions in accordance with the requirements of the submission templates. We have a strong track record of delivering systematic reviews for NICE submissions and have received positive feedback from the ERG on these. Our rapid and pragmatic literature reviews are similarly approached in a methodical, transparent and reproducible manner.
  • High quality written reports. We aim for exceptional clarity and maximum attention-to-detail in the communication of our methodology and results, with our reporting standards adhering to PRISMA guidelines. We are also experienced in publishing the results of our work in collaboration with clients, both as congress abstracts and peer-reviewed journal publications. Please contact Saoirse Leonard for a list of these publications.
  • Transparent and accurate budgets, with no hidden fees. At the proposal stage, we invest considerable effort in scoping the size of a review, in order to provide clients with budgets based on tried-and-tested search strategies generating known numbers of search results. We understand that systematic reviews in particular represent a large investment for our clients, so we are dedicated to optimising the efficiency of the searching and review stages of these projects, and have developed several tools to automate these stages as far as possible. For information about our in-house machine learning research presented at the Cochrane Colloquium congress in 2015, please contact Sara Steeves.
  • Extensive in-house collaboration. Costello Medical’s Evidence Development Division works closely with other specialised teams within the company, meaning that any subsequent stages of a project (such as meta-analysis, HTA submissions, value materials or publications) benefit from the involvement of dedicated experts, as well as the supervision and oversight of the original project manager throughout.

Please contact Saoirse Leonard for further information about our evidence development services.

We were approached by a client to conduct a systematic literature review and meta-analysis on the risk of adverse health outcomes associated with substance misuse, in order to support the value communication of a novel pharmacological therapy in this disease area.

Throughout the project, we provided strategic leadership to ensure that the review was conducted to the highest academic standards as well as being targeted to the client’s needs. For example, the thorough scoping we conducted at the proposal stage identified that the evidence base for the topic planned was extremely large. In order to maximise the ability of the review to identify all relevant studies within the client’s required timelines, we recommended focusing the topic area of the review on a single adverse health outcome of particular importance. This recommendation was approved by the client and allowed the development of highly sensitive search terms for the review.

The review was conducted using the most stringent methodology recommended in the Cochrane Handbook for Systematic Reviews of Interventions and by the University of York’s Centre for Reviews and Dissemination. Two reviewers independently screened the articles at both the abstract and full-text review stages, and resolved any disagreements regarding the eligibility of an article by discussion until a consensus was met. Comprehensive hand searches of the bibliographies of included articles were also conducted in order to identify further potentially relevant studies for inclusion in the review. As we strongly believe that assessing the quality of studies included in a systematic review is essential, we identified a relevant, detailed and recently published quality assessment form and tailored it to align with the objectives of our systematic review. We then applied the quality assessment to each included study in order to remove any studies that were not credible from the meta-analysis.

As well as involving a large number of articles, the review was highly complex as it included observational studies published over a period of more than fifty years. The terminology, understanding and reporting of the disease area have evolved considerably over this time period leading to high heterogeneity between studies. We were able to use our expertise and insight into the disease area to make informed decisions on which studies met our eligibility criteria, and to produce an insightful written analysis of the results. The client was delighted with our clear and thorough report.

We subsequently collaborated with the client, an external author, and Costello Medical’s Publications Division to prepare the results for publication, in line with the PRISMA and MOOSE reporting guidelines for systematic review and meta-analyses.

We were asked by a client to conduct a series of literature searches to identify published data, future studies and the views of key opinion leaders on a number of topics of interest to support the strategic positioning of a drug due to enter Phase III development.

The project had three key objectives: to identify the most pertinent data in an efficient but rigorous manner; to record the search results comprehensively in a format that could be updated in the future; and to provide a visual summary of the key findings from these searches for internal alignment purposes and to support conversations with key opinion leaders.

To address the first objective, we defined in collaboration with the client a series of strategic evidence searches for publications, congress abstracts, clinical trials, treatment guidelines and articles posted on commercial and pharmaceutical news websites, adjusting the search terms until a suitable balance between sensitivity and specificity was reached.

We developed interactive Excel trackers to document each search and to provide a comprehensive library of the search results. The trackers included illustrative summary metrics of the searches and all search results were classified by their source and assigned relevance scores so that relevant items could be located easily.

We subsequently evaluated the search results to address specific questions from the client, as well as to identify key trends in the data with a focus on unmet patient needs and gaps in the current treatment paradigm. We conveyed our findings in a PowerPoint presentation using a combination of summary diagrams and more detailed descriptions of important studies.

The feedback from the client was overwhelmingly positive, with the results of the searches used to inform advisory board discussions and the project evolving to include further topic areas and periodic updates across all topic areas.