The TMF is the official record of the clinical study for Regulatory Authorities, be it…
Continued from ‘5 step’ fail proof strategy to effective Clinical Trial Agreement Negotiation 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:
- An academic researcher in oncology (5+ years) scrambling for research funding and publication opportunities.
- An industrial research lead (6+ years) at a small biotechnology company searching for new oncology drug targets.
- A Director at a personalized medicine non-profit organization (1 year).
- 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:
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 3: First in Line – Avoiding getting stuck in the contracts office queue.
There’s no sense in having a great CTA template with a site if it waits in line at their contracts office for 3 months before being looked at. Knowing the key individuals in the site contracts offices, and having those established relationships with Investigators, can help get the CTA into the right hands. ASAP.
Step 4: Site Buy-In – Avoiding delays or unexpected problems during CTA negotiation.
To avoid delays you need to have built previous experience and professional collaboration with all site contracts teams. You need to know the method of operation of the contracts reviewers and the regulations at each site contracts office. This is established through time and through Scimega’s repetitive collaboration with the same sites and individuals throughout Canada.
Step 5: True Teamwork – Tandem CRO-Sponsor review of CTAs with each site.
The negotiation on behalf of the sponsor doesn’t mean Scimega shows up a month later with a signed clinical trial agreement for them. It is necessary that the sponsor is a direct participant in the process. Scimega negotiates and signs the CTA on the sponsor’s behalf, but in a fully transparent and integrated fashion. The sponsor also signs a commitment within the agreement. The sponsor is consulted, advised, and gives approval at EACH step of the negotiation process.
Contribution by: Dr. Nathan Currier, Director Oncology Strategy and Alliances