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Decision-makers have become increasingly interested in incorporating real-world evidence (RWE) into their decision-making process. Due to concerns regarding the reliability and quality of RWE, stakeholders have issued numerous recommendation documents to assist in setting RWE standards. The fragmented nature of these documents poses a challenge to researchers and decision-makers looking for guidance on what is ‘high-quality’ RWE and how it can be used in decision-making. We offer researchers and decision-makers a structure to organize the landscape of RWE recommendations and identify consensus and gaps in the current recommendations. To provide researchers with a much needed pathway for generating RWE, we discuss how decision-makers can move from fragmented recommendations to comprehensive guidance.

To complement real-world evidence (RWE) guidelines, the 2019 Structured Preapproval and Postapproval Comparative study design framework to generate valid and transparent real-world Evidence (SPACE) framework elucidated a process for designing valid and transparent real-world studies. As an extension to SPACE, here, we provide a structured framework for conducting feasibility assessments-a step-by-step guide to identify decision grade, fit-for-purpose data, which complements the United States Food and Drug Administration (FDA)'s framework for a RWE program. The process was informed by our collective experience conducting systematic feasibility assessments of existing data sources for pharmacoepidemiology studies to support regulatory decisions. Used with the SPACE framework, the Structured Process to Identify Fit-For-Purpose Data (SPIFD) provides a systematic process for conducting feasibility assessments to determine if a data source is fit for decision making, helping ensure justification and transparency throughout study development, from articulation of a specific and meaningful research question to identification of fit-for-purpose data and study design. BACKGROUNDAccess to extensive and diverse real-world data (RWD) sources has grown exponentially over the past decade. [1][2][3] Receptivity to using RWD in real-world evidence (RWE) to complement clinical trial evidence has simultaneously increased, 4-7 leading to more frequent inclusion of RWD studies in regulatory and payer submission packages, 8,9 but with mixed success. Whereas particular therapeutic areas, such as oncology and rare diseases, have historically utilized RWE, advances are being made to understand the optimal settings for producing RWE fit for decision making by regulators, payers, and health technology assessment agencies. 10 Standardssuch as guidance documents, step-by-step processes, and templates, developed to guide researchers on the design and conduct of RWD studies-support validity and transparency, and ultimately bolster confidence in RWE. These good practices cover the continuum 11 from articulating a clear research question 12 to transparency in study conduct and reporting of results, [13][14][15][16] and include consideration of the hypothetical target trial, 12,17 identifying confounders by constructing causal diagrams, 12,18,19 identifying a fit-for-purpose design, 12,20 protocol development, [21][22][23][24][25][26][27] and visualizing the study design. 20 A Structured Preapproval and Postapproval Comparative study design framework to generate valid and transparent RWE (SPACE) framework elucidated a step-by-step process for designing valid and transparent real-world studies and provides templates to capture decision making and justification at each step. 12 The structured template for planning and reporting on the implementation of RWE studies (STaRT-RWE) picks up where SPACE leaves off, providing detailed templates to capture the final design and implementation details (e.g., specific algorithms for each study variable). Taken...

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British Columbia listing decisions for 74% of the drugs reviewed by CADTH. Ontario agreed with CADTH for 76% of the drugs. Positive CADTH recommendations in particular often translated to availability in British Columbia and Ontario. Of the 57 drugs that received positive CADTH recommendations, 82% (47) are available in BC and 93% (53) are available in Ontario. Of the 36 drugs receiving negative CADTH recommendations, 61% (22) are unavailable in BC and 50% (18) are unavailable in Ontario. ConClusions: A positive CADTH recommendation is a good predictor of drug availability in British Columbia and Ontario. A drug that receives a negative CADTH recommendation, however, still has a significant probability of being listed by each province's health care system, especially through their special access programs. HC2