{"id":15680,"date":"2022-02-08T08:36:40","date_gmt":"2022-02-08T13:36:40","guid":{"rendered":"https:\/\/cdtrp.ca\/?p=15680"},"modified":"2022-02-08T09:26:51","modified_gmt":"2022-02-08T14:26:51","slug":"cdtrp-research-services-clinical-trial","status":"publish","type":"post","link":"https:\/\/cdtrp.ca\/en\/cdtrp-research-services-clinical-trial\/","title":{"rendered":"CDTRP Research Services for the community: Clinical Trial Design and Support"},"content":{"rendered":"

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CDTRP Research Services for the community<\/h4>\n

Since 2013, the CDTRP has supported research and innovation that addresses barriers within the fields of donation and transplantation, with the goal of advancing long-term health outcomes and quality of life for Canadian transplant patients. Over the course of the next few weeks, we will highlight the tools and resources that CDTRP can offer to assist you and your project for the upcoming spring grant competitions.<\/em><\/p>\n<\/div>

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Request support from Cdtrp<\/span><\/a><\/div>
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Clinical Trial Design and Support<\/strong><\/h5>\n

The CDTRP can connect investigators to the right experts for advice in designing and running clinical trials, including access to biostatisticians, resources to develop contracts, submissions to institutional research ethics boards and Health Canada regulatory approval. The CDTRP can also connect investigators to a contract research organization, support identifying contacts at sites for multisite studies, and facilitate a review panel for a trial protocol. Clinical studies can request use of the CDTRP\u2019s independent Data Safety Monitoring Board (DSMB)<\/strong> to help monitor progress and adverse events and provide arms-length advice on patient safety and trial accrual. The DSMB comprises 7 voting members that independently review and evaluate study data for participant safety, study conduct and progress, and recommend continuation, modification or termination.<\/p>\n

For more information, please email your request to info@cdtrp.ca<\/a>.<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div>

Invaluable arms\u2019-length independence<\/strong><\/h5>\n

You can\u2019t do a transplant randomised controlled trial (RCT) in Canada without the CDTRP\u2019s DSMB. Alphabet soup aside, that\u2019s the conclusion UManitoba\u2019s Julie Ho came to.<\/p>\n

Julie is the principal investigator of the CIHR-funded CXCL 10 Project: a multi-centre international RCT in adult kidney transplant recipients to see if identifying CXCL 10 and treating rejection in time improves 12-month outcomes.<\/p>\n

The CDTRP offers its Data Safety Monitoring Board (DSMB) to help monitor progress and adverse events in clinical trials, and provide arms-length advice on patient safety and trial accrual. It independently reviews and evaluates study data for participant safety, study conduct and progress; and recommends continuation, modification or termination. Enrolled trials (currently six of them) also submit biannual progress reports and presentations for the DSMB to challenge.<\/p>\n<\/div>

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\u201cI have the best interest of my patients at heart but because I\u2019m embedded in the trial, I may have inherent bias. Having that arms\u2019 length look at safety is imperative. You can\u2019t do a trial without it.\u201d<\/span><\/strong><\/h5>\n
– Julie Ho, Leader, CXCL 10 Project<\/span><\/strong><\/h5>\n<\/div>
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Julie finds the DSMB\u2019s role as a sounding board most helpful. The past few years have been a challenge for non-COVID-related trials, especially those with vulnerable segments of society such as immunocompromised transplant patients. Julie had to modify the protocols to meet public health requirements. The DSMB was able to reassure her that she wasn\u2019t introducing bias at the same time.<\/p>\n

Without the DSMB, Julie says the trial would be in trouble.<\/p>\n

“If you\u2019re a drug company, it\u2019s not a big deal to hire a DSMB,\u201d she says. \u201cBut when you\u2019re government-funded and investigator-led, you don\u2019t have the same resources. The DSMB is an easy place for us to go instead of cobbling together individuals myself manually, with all the time and effort involved. It\u2019s not efficient. The CDTRP is a good central place for us to access this resource.\u201d<\/p>\n

The DSMB is part of the Clinical Trial Design and Support, whose other services include connecting investigators to a contract research organization, identifying contacts at sites for multisite studies, and facilitating a review panel for a trial protocol.<\/p>\n<\/div>

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To learn more on the Research Services the CDTRP can offer, visit our website<\/a>.<\/h5>\n<\/div>
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