Evaluation of the Canadian Remote Access Framework for Clinical Trials (CRAFT) Pilot: a Qualitative Study
Bibliographic record
Abstract
Objectives Clinical trials provide opportunities for patients to access novel diagnostic screening, treatment, and supportive care options. Trial access is limited for many Canadians due to distribution and distance from cancer centres with clinical trials. In 2021-23, the Canadian Remote Access Framework for Clinical Trials (CRAFT) was implemented as a proof of concept (PoC) pilot to reduce these inequities by bringing trial opportunities to patients living outside metropolitan areas. CRAFT involves a “primary” site that delegates specific trial responsibilities to regional “satellite” centres to form a “trial cluster.” Our objective was to evaluate the CRAFT pilot implemented in three Canadian provinces: British Columbia, Ontario, and Newfoundland. Methods We recruited healthcare professionals participating in the PoC at primary and satellites locations. Using a framework with deductive and inductive codes, two researchers independently analyzed the interview data applying principles of constant comparison. Disagreements were settled by consensus. Results Thirteen one-on-one interviews were conducted with participants from British Columbia (n=4), Ontario (n=6), and Newfoundland (n=3). Participants endorsed CRAFT as means to improve equitable access to experimental therapies for underserved populations; upskill regional healthcare teams; integrate satellites with primary sites; and re-envision future trial delivery. Challenges included responsibilities for contract review and approvals at smaller centres and coordinating research services and senior management support across sites. Conclusions Healthcare teams endorsed CRAFT to improve equitable access to trials and grow research capacity. A follow-up workshop of all relevant parties in March 2025 addressed needed improvements in research, technology, and governance infrastructure to scale CRAFT to new jurisdictions. Public Interest Summary: Clinical trials create opportunities for patients to access new and innovative approaches to treatment, and clinical trial activity has been reported to improve health system performance. However, patients living in rural and remote regions face barriers to trial participation, including financial, time, and health costs to travel to trials in metropolitan centres. Decentralizing clinical trial delivery, where some trial-related activities take place in regional hospitals, can help mitigate these inequities. This study evaluated a pilot demonstration of the Canadian Remote Access Framework for Clinical Trials (CRAFT) in oncology in three Canadian provinces in 2021-2023, from the perspectives of healthcare professionals participating in the pilot. The framework was endorsed by healthcare professionals to help reduce inequities in trial access and grow research capacity. Study findings show better infrastructure support (e.g., contract review, IT integration) and regulatory support (e.g., lowering barriers between health authorities) are needed to link community hospitals with the primary trial site. Clinical trials offices familiar with decentralized processes are also needed to scale the model to other provinces and diseases.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.344 | 0.374 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.003 | 0.005 |
| Science and technology studies | 0.018 | 0.011 |
| Scholarly communication | 0.010 | 0.004 |
| Open science | 0.007 | 0.010 |
| Research integrity | 0.004 | 0.006 |
| Insufficient payload (model declined to judge) | 0.006 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".