Clinical Trials Program (Golden Horseshoe Biosciences Network) Guidelines

A pilot PROGRAM for clinical trials (testing) of Ontario innovative products in the field of Medical and Assistive Technologies (MAT), to assist SMEs, has been established in a collaborative venture among the Golden Horseshoe Biosciences Network (GHBN), Hamilton Health Sciences (HHS), htx.ca - The Health Technology Exchange (HTX) and McMaster University. Letters of Intent (LOIs) are invited from suitably qualified organizations that wish to be considered for support via this PROGRAM. The PROGRAM is restricted to devices that are not likely to require significant regulatory approval (i.e. Class 1 devices). The available pool of funds for this pilot project is currently $200,000. It is anticipated that several products will be supported from the available pool of funds. Successful applicants will be expected to match the amount of any grant made available to them.

LOIs will be evaluated based on information relating to the product to be evaluated including its innovation, market niche, anticipated market impact, its likely patient impact, and suggestions regarding the protocol of the proposed trial or testing. Those who are successful in this first round of adjudication will be invited to meet with the representatives of GHBN, HHS, HTX and McMaster University to discuss details of a possible clinical trial to be conducted with expertise from the University and its affiliated Hospitals. An estimate of the costs of each specific trial will be done collaboratively with the company. Day to day running costs will be drawn from the funds contributed by the program and the company. Hospital and University overhead costs and certain costs possibly incurred by committed, directly involved expert academic investigators, will be included through a negotiated agreement among the parties directly involved. This might include an equity position or a royalty return on eventual sales of the product. It should be recognized that the credentials of the parties conducting the trials would serve as a strong selling point for products that meet the rigours of the protocols developed. The testing unit would take responsibility for the mandatory ethical aspects and related requirements of the institutional Research Ethics Board. Following on the clinical trial, it is expected that in addition to a report detailing the protocol and the results, a publication would be prepared for submission to a peer-reviewed journal pertinent to the domain of application of the product.

Deadline

LOIs should be submitted electronically to the HTX office at jwoods@htx.ca by September 1, 2008.

Award Notification

Notification letters will be sent ordinarily within 4 weeks of the deadline for submissions to all applicants following final decisions. Letters to successful project leaders will provide instructions on how to proceed with the establishment of the project.

For Additional Information Contact:

Jennifer Woods, Director of Operations
htx.ca - The Health Technology Exchange
MaRS Centre
101 College Street, Heritage Level, HL32
Toronto, ON   M5G 1L7
Tel: 416-673-8481 | Fax: 416-597-1160
jwoods@htx.ca | www.htx.ca