The evolution of the Council of Academic Hospitals of Ontario statement of principles--a successful harmonization initiative.

Author:Porter, Katie
Position:Clinical report


To improve efficiency, consistency and transparency in clinical trial contract negotiations with industry sponsors, a Council of Academic Hospitals of Ontario (CAHO) committee facilitated the development of standard principles for member hospitals to follow during contract negotiation. The principles are available on-line for reference by institutions and industry (Slutsky et al., 2010). Hospitals were encouraged to provide a link to the CAHO document on their websites, which facilitated greater transparency. This living document was most recently updated in May 2010, and comments are welcome at any time. The public availability has allowed institutions in other jurisdictions, as well as community hospitals in the province, to align their standards with those of Ontario academic hospitals.

A strong competitor in the clinical research field, Ontario brings a wealth of resources to the table, including 25 CAHO member hospitals, each with a strong focus on research and innovation; a large and diverse patient population to draw from, and a mandate from the Ontario Government's Ministry of Research and Innovation to establish Ontario as a globally recognized knowledge based economy (Queens printer for Ontario, 2010).

To continue to build the foundation of research and innovation needed to draw industry-sponsored research to the province, the CAHO aimed to streamline the contract negotiation process to effectively address one of the most important factors driving clinical trial competitiveness today--speed (Ferris, et al., 2009). Outlining hospital contract standards allows companies to develop or modify their contracts to reduce or eliminate negotiation time, with the goal of starting trials more quickly.

Industry sponsors were consulted as the standard principles evolved. A draft document sent to four pharmaceutical companies received positive feedback. Input regarding indemnification, intellectual property and privacy provisions was considered and incorporated into the principles document. (Moldofsky, Arts, & Slutsky, 2010).

The CAHO statement is accessible to everyone via the internet and invites feedback via an email address. Sponsors are now working collaboratively to agree upon and document industry principles. When this document is complete and publicly available, sites will have greater clarity and consistency on sponsor objectives, and another tool to facilitate communications between parties.

CAHO Principles in the Context of Other Harmonization Efforts

Other harmonization initiatives such as the Model Agreement Group Initiative in the United States (MAGI, 2011), the United Kingdom's Clinical Research...

To continue reading