THE PROCESSES FOR A COMMON QUALITY ASSURANCE APPROACH TO MULTI-CENTRE CLINICAL TRIALS – THE MARS EXCITE EXPERIENCE

Author(s)

Aziziyeh A1, Easty T2, Khayat Z1, Kozlowski N3, Bowen J4, Rac V5, Garritty C6, Levin L1
1MaRS Discovery District, Toronto, ON, Canada, 2University Health Network, Toronto, ON, Canada, 3Applied Health Research Centre, Toronto, ON, Canada, 4St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada, 5University of Toronto, Toronto, ON, Canada, 6Ottawa Hospital Research Institute, Ottawa, ON, Canada

MaRS EXCITE is an innovation in health technology assessment (HTA) where industry, academia, and the health system collaborate to design and execute a robust evaluation program for innovative medical technologies with high disruptive potential that proactively satisfies regulatory and reimbursement decision-makers requirements. EXCITE compromises five Methodological Centres (MCs) across Ontario, Canada with demonstrated excellence in methodologies for designing and conducting complex, multi-centre trials and HTAs. The MCs develop the protocol collaboratively with industry and experts, and oversee the clinical trials, involving multiple participating sites. In an attempt to promote consistency in Quality Assurance (QA) amongst MCs and participating sites for EXCITE studies, EXCITE has developed SOPs, through the Clinical Trials Methodology Committee, that relate exclusively to the unique collaboration with the MCs. These were developed through an analysis of host institution SOPs and developing overarching SOPs that were either unique to the EXCITE QA program, or where deemed appropriate though lacking from some host institutions. This harmonization of SOPs across the five current EXCITE MCs has allowed EXCITE to address one of the main goals of clinical trial QA that is integrity of data. The second goal of clinical trial QA, patient safety, is achieved through the Safety Advisory committee, which sets safety standards that must be adhered to by the MCs evaluating the technologies. The committee reviews all protocols to ensure that patient safety issues are addressed,makes recommendations for protocol changes as necessary and may also mandate training requirements to ensure competency in utilization of any medical technology undergoing testing in the EXCITE program.   Therefore, MaRS EXCITE was able to deploy a collaborative platform to harmonize the QA processes across five independent academic methodological centres in order to conduct efficient and effective clinical trials that are used in evaluating disruptive medical technologies in an effort to optimize patient outcomes.

Conference/Value in Health Info

2015-05, ISPOR 2015, Philadelphia, PA, USA

Value in Health, Vol. 18, No. 3 (May 2015)

Code

PRM147

Topic

Methodological & Statistical Research

Topic Subcategory

Confounding, Selection Bias Correction, Causal Inference

Disease

Multiple Diseases

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