Regulatory Approval To Patient Access, An Evaluation of Eu5 And Us National Timing Differences: An Update

Mycka, J.; Dellamano, R.; Lobb, William B.; Dalal, Nataly; Pereira, Eduardo; Dellamano, L.; Sagaydachnaya, O.

doi:10.1016/j.jval.2014.08.1075

Cited by 1 publication

(1 citation statement)

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“…In contrast, cost-effectiveness criteria are included as part of the deliberative frameworks of the pan-Canadian Oncology Drug Review 31 and the Institut national d'excellence en santé et en services sociaux 32 (together with evaluations of overall clinical benefit, alignment with patient values, and feasibility of adoption into the health system), and those considerations feature prominently in coverage decisions 26 . Finally, the funding review process for oncology medications takes much longer in the Canadian public sector: more than 1 year 33 compared with just over 1 month in the United States 34 . Consequently, the Canadian Pathway recommendations were adapted to include a greater focus on public systems of health technology assessment and reimbursement.…”

Section: Systems Of Approval For New Cancer Treatmentsmentioning

confidence: 99%

Developing a Model of a Patient-Group Pathway to Accessing Cancer Clinical Trials in Canada

Batist

Michaud²,

Richards

et al. 2018

Current Oncology

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Background Colorectal Cancer Canada, in partnership with a Scientific Advisory Committee, is developing a Canadian Patient Group Pathway to Accessing Cancer Clinical Trials (“Pathway”). A central element of the Pathway is presented here—namely, a set of recommendations and tools aimed at each stakeholder group.Methods A summary of the peer-reviewed and grey literature informed discussions at a meeting, held in June 2017, in which a cross-section of stakeholders reached consensus on the potential roles of patient groups in the cancer clinical trials process, barriers to accessing cancer clinical trials, best practice models for patient-group integration, and a process for developing the Pathway. Canadian recommendations and tools were subsequently developed by a small working group and reviewed by the Scientific Advisory Committee.Results The major output of the consensus conference was agreement that the Clinical Trials Transformation Initiative (ctti) model, successfully applied in the United States, could be adapted to create a Canadian Pathway. Two main differences between the Canadian and American cancer clinical research environments were highlighted: the effects of global decision-making and systems of regulatory and funding approvals. The working group modified the ctti model to incorporate those aspects and to reflect Canadian stakeholder organizations and how they currently interact with patient groups.Conclusions Developing and implementing a Canadian Pathway that incorporates the concepts of multistakeholder collaboration and the inclusion of patient groups as equal partners is expected to generate significant benefits for all stakeholders. The next steps to bring forward a proposed Pathway will involve engaging the broader cancer research community. Clinical trial sponsors will be encouraged to adopt a Charter recognizing the importance of including patient groups, and to support the training of patient groups through an independent body to ensure quality research partners. Integration of patient groups into the process of developing “real world” evidence will be advanced by a further consensus meeting being organized by Colorectal Cancer Canada for 6–7 November 2018.

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Section: Systems Of Approval For New Cancer Treatmentsmentioning

confidence: 99%