RWE is produced by using data from routinely collected sources, such as electronic heath records (EHRs), registries and patient-generated data, including patient reported outcomes (PROs). It is a pragmatic way to design efficient, less costly and robust clinical studies. We have designed over 20 investigations using these data sources in the past 3 years in collaboration with our experts and partners
Registry and CRN development
Registries are an important infrastructure for generating real world evidence and our partners are international leaders in registry science. One of our important partners is MDEpiNet that initiated a collaboration with International Medical Device Regulators Forum (IMDRF) to define evidence and regulatory standards for registries. The linking of registries with other relevant data sources allows long-term evaluations of therapeutics using Coordinated Registry Networks (CRNs). The development of CRNs was led by the FDA and MDEpiNet with the aim of creating partnerships and methodologies to evaluate medical devices throughout the total product life cycle (TPLC). In partnership with MDEpiNet HIVE leverages CRNs to not only provide evidence on safety and effectiveness of devices, but also propose nested clinical study designs that can expedite patient recruitment at a lower cost than traditional clinical research.
Objective Performance Criteria and outcome benchmarking
Objective Performance criteria (OPC) are numerical target values of safety or effectiveness endpoints derived from various data sources, such as historical published data, newly conducted clinical studies, on-going registries and analyses of administrative databases. In some instances, evidence syntheses are also performed to develop OPCs. OPCs may be used in single-arm studies of established technologies whenever comparative studies are not feasible. Manufacturers and innovators can also use this method for evaluation of early-stage innovations using performance goals. We have expertise to construct OPCs and performance goals using advanced methods such as conducting direct analysis of registry or claims data or combining estimates obtained from different studies and those reported in the literature.
Advanced Study design
HIVE experts use innovative methods in epidemiology, health services research, biostatistics, and regulatory science to help investigators design pragmatic fit-for-purpose studies. Technology safety and effectiveness is often intertwined with interventional care including surgery. We have unique surgical and interventional care expertise to help investigators answer important clinical and regulatory questions pertinent to fusion of health technologies, surgical interventions and interventional care. We also offer services for using advanced analytic methods such as propensity score matching, inverse probability weighting or machine learning. Advanced study design and analytic methods help our investigators address complex device questions and provide convincing evidence for decision making.
CRN maturity model
HIVE can provide guidance and services to stakeholders developing registries and research networks that are integrating real world data from multiple data sources. Our partner MDEpiNet has developed a research network assessment tool based on the seven domains of coordinated research network maturity. National experts and collaborators from academic, clinical, industry and regulatory settings participated in the development of the framework for assessing CRN maturation. The seven domains of the CRN maturity model are: Device Identification; Patient reported outcomes and Patient engagement; Data Quality; Efficiency; Governance & Sustainability; Health Care Quality Improvement; and Total Product Life Cycle. Each CRN will be able to use this tool to self-assess their maturity. The framework allows he stakeholders to determine the gaps and set priorities for investment in order to showcase high quality data and processes and operate in regulatory environment
Think-tanks and DELPHI consensus Methodologies
To facilitate consensus development for eCRFs or core minimum data collection, HIVE provides services to stakeholders for conducting DELPHI surveys for regulatory purposes. Whether for registry development or conducting clinical study the consensus process is often very important to convince regulators and payers that the data collection is adequate to address their needs. It is a pragmatic way to engage key stakeholders including patients. Use of DELPHI process is more convincing and possibly evidence-based method for reaching concordance when compared to traditional consensus panel approaches that can be biased and influenced by authorities due to lack of anonymity. DELPHI process helps achieve consensus while minimizing bias inherent in group dynamics and face-to-face responses.
IDEAL- D Methodologies
IDEAL for devices (IDEAL-D) is a rational framework for evaluating and regulating the use of medical devices https://www.ideal-collaboration.net/ This approach enables innovators and manufacturers to initiate clinical studies of technologies and devices at every stage of total product life cycle (TPLC). We offer unique study design and methods starting from first in human studies followed by early-stage case series, comparative investigations, and surveillance studies. IDEAL-D is appreciated by surgeons worldwide because it highlights unique aspects of surgical and interventional care and the need to design robust studies that make sense to innovators and patients. We have major methodological expertise to help stakeholders properly apply IDEAL-D methods
