We conduct systematic reviews as well as horizon scans of published and unpublished evidence to inform decision making. We treat evidence review as a scientific research and conduct studies using explicit and reproducible methodologies. We systematically search all relevant literature using robust informatics principles and bring together and synthesise all valid evidence. These studies can answer important questions and also inform the gaps in evidence that need to be filled using real world evidence and clinical research studies.
Evidence searches and analyses
Systematic Literature Review is an important tool used by HIVE experts. We have a systematic process for identification of all available evidence and data extractions. The studies are searched and reviewed by experts using Medline, Embase, Cochrane Controlled Trials Register, reference lists of articles, annual reports of major registries, summaries of safety and effectiveness for pre-market application and mandated post-market studies at the FDA. Data extraction is performed by at least 2 researchers to ensure high quality. Data synthesis are routinely conducted using advanced methodologies of meta-analysis. Our experts are trained in evidence-based medicine and advised well known guideline development groups for quantitative synthesis of data.
Return on Investment (ROI) Assessments
The use of real-world data (RWD) may help overcome the burden and some limitations associated with conducting post-market studies. Generating real world evidence from RWD may also reduce the costs and save time for evidence generation in pre-market studies. However, the evidence for this approach is limited in specific clinical areas. There is a need to demonstrate the Return on Investment (ROI) for these investments by NIH, manufacturers, clinical societies and other stakeholders. HIVE has expertise in calculating the ROI using analysis of traditional clinical trials conducted for regulatory decision making and studies leveraging real world evidence. These methodologies help demonstrate favorable ROI, and emphasize the value of RWD sources for clinical research.
