CADTH, the Canadian health technology appraisal (HTA) body, is consulting on draft guidance on the use of real-world evidence in submissions to both regulatory and HTA decision makers.
The aim of the draft guidance is to “highlight best practices for reporting, as well as important methodological considerations that can help to standardize RWE submissions and maximize their relevance for regulators and HTA bodies in Canada,” according to CADTH. The consultation closes on 6 January.
The draft guidance aligns with guidance on RWE published by other international regulators and HTA bodies, but it also provides “strong consideration of the pan-Canadian health care environment,” says CADTH. Experts from England’s HTA institute, NICE, and the US Food and Drugs Administration contributed to the guidance.
The development of the draft guidance was founded on three main principles:
- to ensure that regulators and HTA agencies have sufficient information to evaluate a submission for its appropriateness of use for decision-making;
- to provide core reporting standards for RWE submissions that align with global standards; and
- to prioritize transparency in reporting while accounting for practical challenges related to RWD and RWE.
The draft guidance aims to ensure “the highest-level of transparency possible in the reporting of submissions” so that Canadian regulators and HTA bodies are given the information they need to interpret the submission and “determine if and how the evidence should be used to inform decision-making,” says the document.
It includes a check list of 92 items that should be addressed in submissions to regulators and HTAs. These relate to issues such as data sources, study design, study participants, definitions and comparators, study findings, as well as bias, confounding and effect modifiers.
The document also notes that it does not provide guidance on when or why RWE should be used, for example whether an RWE study would be suitable for a particular research question. This type of guidance would be a “critical step for future initiatives” that first requires “a strong foundational guidance on the overall reporting of RWE,” says the document.
It also notes that RWE “does not and should not serve as a replacement for clinical trials.” RWE should supplement existing evidence from trials and be considered part of the broader evidence base for decision making.
The guidance is to be a “living document” that will need updates and extensions over time as the field evolves, says CADTH. It was written to allow for flexibility given ongoing changes in the field of RWE and real-world data where advances in data sources and methods come alongside a surge in novel health technologies and medical interventions.
The guidance is part of CADTH’s three-year strategic plan to be a leader in evidence appraisal and optimizing the use of RWE. In September it launched a new program that will harness RWE to provide more information and advice on the safety and effectiveness of drugs that are already approved.
Source: https://pink.pharmaintelligence.informa.com/PS147383/Canada-Consults-On-Real-World-Evidence-Guidance-For-HTAs-And-Regulators