MAGI: Four Days Focused on Clinical Trials

On May 21, 2017 seven members from the Industry Contracting Group (ICG) traveled to Philadelphia, Pennsylvania to attend the 4-day bi-annual Clinical Research Conference put on by the group, Model Agreements & Guidelines International or MAGI. The conference brought together people from a range of different disciplines and backgrounds within research administration including contract research organizations (CROs), academic medical centers and health systems, and community hospitals to discuss clinical trials and clinical trial agreements. MAGI’s stated goal for their conferences is to facilitate networking among different entities working in and with clinical research groups to help standardize “best practices for clinical operations, business and regulatory compliance.” “The goal of our team attending this conference was to learn as much as we could about negotiating clinical trial agreements, clinical trials, and how other, similar sites across the country manage and work in this niche field,” said Daniella Carter, a Senior Sponsored Research Analyst with ICG.

Each day of the MAGI conference, attendees had the opportunity to choose from workshops that fell under six different “tracks” or topic themes such as contracts, budgets & billing, and clinical operations & project management. The ICG team had a primary focus on the contracts track, while also attending select workshops in other tracks. An example of the kind of workshops the team participated in was a day-long “Dissecting a Clinical Trial Agreement” where the participants reviewed and discussed the 22 sections of MAGI’s Clinical Trial Agreement template in detail and from the multiple perspectives represented at the conference. A panel of 3 to 4 individuals, with differing backgrounds including persons associated with CROs, specific sites, and industry sponsors governed each workshop. The panelists would give a presentation on the specific workshop’s topic, from the perspective of their association. Chantrell Lowe, Associate Sponsored Research Analyst, appreciated the conference’s structure, and reflected, “I enjoyed the varied perspectives, there were presentations from sites, sponsors, and CROs. I also appreciated how they included input from each of these sectors from attendees. The inclusion of the attendees allowed you to gain more feedback and network at the same time and the use of a different speaker for each subject also allow you to stay engaged.”

The team learned specific negotiation tactics, recommended contract language, and tangible material related to contracting. Points such as preserving the site’s opportunity to cure in the event of a material breach or when to make a clause mutual, but also big-picture issues like other universities’ positions on retaining intellectual property rights in sponsor-initiated trials and maintaining congruency between the contract and the informed consent form. An underlying theme to the conference was that sponsors and sites share common goals and wish to set up studies as efficiently as possible. As Carter reflected, “Not only are we leaving the MAGI conference having learned a lot about contracting and how to improve our own work, but I think our team learned that we are experiencing many of the same challenges that other sites are facing and we are approaching our challenges in similar ways. It was a great confirmation that we are doing our jobs to the best of our ability.” Carter went on to say, “For me personally, the MAGI conference made me want to be better at what I do. It made me want to take more time when I review a contract to make sure that I am really getting all the nuances that we discussed at the conference.” The ICG team is ready and excited to participate in next year’s MAGI conference!