‘5 step’ fail proof strategy to effective Clinical Trial Agreement Negotiations part 1

Nathan Currier, PhD, is Scimega’s Director of Oncology Strategy and Alliances. He brings a wealth of knowledge and excellent insight into the world of Canadian Clinical Trial Agreement negotiations. Throughout his career, Nathan has served as:

1. An academic researcher in oncology (5+ years) scrambling for research funding and publication opportunities.
2. An industrial research lead (6+ years) at a small biotechnology company searching for new oncology drug targets.
3. A Director at a personalized medicine non-profit organization (1 year).
4. The Director of the research contracts department (3+ years) at the top medical research university in Canada.

Here is the take home message from a recent discussion regarding the key strategies to eliminate study start-up delays caused by contract negotiations:

Nathan:

When negotiating a CTA with a research institution on behalf of a client, it is critical to know the different stakeholders’ methods of operation, the restrictions, their motivations, but most importantly to show empathy for the pressures they work under. The recipe for success in clinical trial agreement negotiation boils down to 5 key elements, or steps. Each may require years to develop properly and nurture, while some simply rely on a change in organizational culture (or policy).

‘5 step’ fail proof strategy to effective Clinical Trial Agreement negotiations

Step 1: First and Final Steps – Contract management from start to finish.

When time is of the essence, the party with the strongest relationship should manage the clinical trial agreement (CTA) from its initial submission to the site, to its full execution and archiving. Sponsors should be looking for clinical research professionals that have preferential access to the institutions’ key influencers, to lead the exercise.

Step 2: You’re Pre-Approved – Sponsor approves Site-Vetted CTA for each site.

Scimega has pre-negotiated CTAs with many Canadian sites. At the very least, Scimega has a library of pre-negotiated CTA language and contractual preferences for all Canadian sites. Your CTA template must be customized and formally recognized by each of them. Our sponsor clients review and pre-approve the use of all template CTAs and alternate clause documentation we use with our sites.

*Note: This step is an essential strategic decision that will directly impact study start-up, SIV timing, and thus FSO/FPI.

Step 3:… see ‘5 step’ fail proof strategy to effective Clinical Trial Agreement Negotiations part 2

 Contribution by: Dr. Nathan Currier, Director Oncology Strategy and Alliances