Doctor Evidence’s (DRE) team of expert methodologists delivers high-quality systematic reviews across the broad spectrum of available medical evidence. DRE’s rigorous systematic review process is based on a “PICOTSS” search strategy (Population, Intervention, Comparator, Outcome, Timing, Setting, Study Design), and evidence included in the evidence reviews can be weighted for relevance according to the PICOTSS selected. Once the relevant evidence has been identified, DRE’s proprietary Digital Outcome Conversion (DOC) process is used to extract data from a set of full-text articles, which are then organized into highly structured data sets. All extracted data can be summarized in text or table format, enabling a fully transparent and reproducible understanding of the individual data by referring back to individual referenced papers and specific data elements. From this rich data source, our expert team provides impactful and comprehensive review services to help clients make important evidence-based decisions.
DRE performs rapid feasibility assessments of client questions using the DOC Search proprietary search engine, which features state of the art semantic web, natural language processing, and machine learning technologies. This allows the landscape of biomedical literature to be quickly captured from over 29 million documents in PubMed, ClinicalTrials.gov, European Public Assessment Reports (EPARs), American Society of Clinical Oncology (ASCO) abstracts, and over 85 social media, news, and official RSS feeds.
Within 1-2 days, a brief report that describes the search (including ontology, study design, time period, and geography) is presented to clients to understand the feasibility of conducting a focused or systematic literature review. Rapid Assessments provide answers to simple questions, and often lead to a more refined set of questions that address more complex matters.
Systematic Literature Reviews
The DRE team of methodologists use well-standardized and currently accepted methodologies, blended with state-of-the-art technology in an agile manner to conduct systematic literature reviews (SLRs) of clinical trials and real-world evidence across all therapeutic areas. Use of sophisticated methodology and technology helps policy-makers, pharmaceutical industry clients, academic institutions, and physicians make confident decisions based on scientific literature. The entire process of systematic literature review and the subsequent analysis, as well as appropriate tables, graphs, and outputs are generated and recorded within an integrated system (DOC Library and DOC Data), making the process both transparent and reproducible.
Competitor Label Review
The DOC Label platform is used by top companies to compare all US and UK labels side-by-side with advanced, intuitive analytics. Competitive label review, understanding key outcomes and indications, and tracking changes to existing labels over time enables regulatory and commercial teams to quickly search, track, and synthesize multiple labels quickly and efficiently. Updates happen in real-time, allowing client teams to stay up-to-the-minute as a label is drafted and updated.
Focused Literature Review
Some questions require a comprehensive but non-systematic targeted literature search, focused on, for example, epidemiology (incidence, prevalence, mortality, risk factors, etc.), burden of disease, and standard of care. In these situations, DRE tailors the review process to meet client requirements. For example, DRE might sometimes choose the best available evidence when multiple observational studies or clinical trials from the same country provide prevalence data.
Payer Dossier Preparation
DRE prepares dossiers for reimbursement negotiations. This includes the individual components of analyses such as comparative clinical as well as economic modeling. These are formatted into the respective styles as laid out by the National Institute for Health and Care Excellence (NICE), Pharmaceutical Benefits Advisory Committee (PBAC), and Academy of Managed Care Pharmacy (AMCP), along with other major payers. DRE has experience working with global functions to prepare Global Value Dossiers and adapting these to the specific needs of local affiliates, including the U.S., EU5, and major emerging markets.