The TMF is the official record of the clinical study for Regulatory Authorities, be it…
Whether in Canada or any other country it is no secret that executing Clinical Trial Agreements (CTAs) is often the bottle neck to getting a clinical trial site up and running. Study statistics indicate it can take over three months to complete a CTA.1 Not surprising given the complexity of the drafts exchanged between negotiating parties of this lengthy document, sometimes over 30 pages long, and governing all aspects of a clinical research study (e.g. rights and obligations of each party involved in the clinical trial).
Why Oncology is Different
When negotiating an oncology CTA in Canada, it is helpful to understand that there are many cancer research centers across the country with over 1000 recruiting trials in oncology alone. This number has grown significantly over the last 10 years, and is sure to continue growing as biopharma companies develop more effective and promising treatments.
Based on the numbers today, an average Canadian site has 20 or more oncology related CTAs to review from various Sponsors at a given time. This is in addition to all other legal documents awaiting review. Unsurprisingly given their intrinsic complexity, oncology clinical trials have especially long agreement negotiation timelines compared to trials in other therapeutic areas.2
While for many of the smaller centers that often have less than a handful of reviewers this may be more of a challenge. Additionally, emerging trends like immune-oncology have new risks that negotiators must consider, which may lead to even longer CTA negotiation timelines.
These delays have a significant impact on the thousands of patients who depend on the execution of CTAs that then allow them to participate in new and potentially life-saving clinical trials at their local investigative site.
To effectively address the overall delays in CTA completion, Sponsors should consider the following recommendations from an experienced partner with proven success and speed of clinical study start-up.
Understand Country / Site Requirements
It is vital that Sponsors understand the specific requirements of the countries and sites on their list. For example, many sites in Canada insist on using model agreements due to their limited ability to review fresh CTAs.
While sites are willing to negotiate the terms of their model agreements, they often require special approvals for certain items. As such, knowing which individuals at a site need to be involved in negotiations so that special approvals can be obtained without undue delay is important. Sponsors can prevent such delays from arising by proactively seeking business intelligence and knowledge of specific site requirements.
Working with our network of Canadian sites for over 20 years, Scimega has built relationships with most – if not all – leading oncology sites in Canada and is well positioned to assist Sponsors with site-specific requirements, and thereby reduce clinical study start-up times.
The more “sticking points” we encounter negotiating CTAs on behalf of Sponsors, the more knowledgeable we’ve become in this stage of clinical study start-up. Based on extensive experience with Canadian oncology sites, Scimega has developed a comprehensive template CTA. With this, in collaboration with Scimega, Sponsors can readily present a model agreement that anticipates Canadian sites’ concerns and thereby shorten the lead time to getting their clinical studies up and running.
Simplify Legal Language
It is widely known that legal language is another pain point that threatens the timely execution of CTAs. The issue has prompted much-needed industry focus and related initiatives in recent years. In Canada an attempt has been made to create and accept a standardized CTA across all sites (i.e., the CCTCC’s Model Clinical Trial Agreement). There is, however, still much work to be done to make it as effective as it could be.
To overcome the challenges of multiple sites with varied and distinct requirements bogging down CTA negotiations, Scimega has developed a database of site-specific Canadian CTAs. This provides Sponsor partners access to standardized legal language that streamlines their negotiations with sites.
Through its site-specific Canadian CTA database, Scimega has verified and pro-actively assessed individual site needs in Canada so that we can work with Sponsors preemptively to anticipate and focus in on “sticking points” in CTA negotiations with each site.
Eliminate Cumbersome Internal Processes
Significant delays in CTA negotiations can be hidden in plain sight. Such as internal Sponsor or CRO processes with too many unnecessary steps. Something as simple as multiple transfers between a Sponsor’s team members can easily delay CTA negotiations (i.e., from Sponsor’s in-house counsel to external counsel and then back to Sponsor’s in-house counsel). Such delays occur before the CTA even reaches the CRO who must then deliver the CTA to the site manager who forwards it on to the site legal team. Delays can be further complicated when internal processes set by Sponsors or global CROs do not account for or anticipate country, site, or individual holidays / vacations, which can easily result in more individual hand-offs of the CTA.
Whether the CTA is negotiated using internal staff, a contract negotiation vendor, or a CRO, Sponsors should look for opportunities to delegate authority to only those appropriate individuals whose involvement expedites the negotiation process.1
Scimega recommends Sponsors assign one internal contact to interact directly with their CRO whose country-specific expertise allows them to manage expectations and negotiations directly with sites. After all, any CRO with actual country-specific expertise will have already built and be maintaining a solid network of site relationships, with the relevant, valuable institutional knowledge necessary to fulfill this requirement.
The key here to reducing clinical study start-up times is to streamline, streamline, and streamline. When it comes to CTA negotiation, less is more – while ensuring Sponsors’ legal interests are well protected of course.
Ensure Clinical Operations and Legal Integration
Failure to properly integrate the Clinical Operations and Legal teams at the Sponsor level can often lead to CTA negotiation delays. A common issue seen by Scimega is Sponsors’ legal teams unaware of contracts required by their internal Clinical Operations team.
With neither team to blame, the issue usually emerges out of a lack of clear processes in place to ensure appropriate integration across these business functions. The Clinical Operations team may not be aware of when to involve their Legal team, or if they do, it may be too late because the Clinical Operations team has already started new work that requires amendments to the Study Protocol, Budget, or CTA.
At Scimega, the contracts management team ensures amendments required to Study Protocols, Budgets, or the CTA do not hold up the Clinical Operations teams’ work, period. Regardless of possible cause. Our dedicated staff keep lines of communication between the Clinical Operations and Legal teams open, with visibility into what each team needs at a given time. This allows each team to anticipate the other’s needs and efficiently distribute workloads to better manage contract negotiations with sites in parallel with study-related activities.
The end result is what every Sponsor looks for: shorter clinical study start-up times and quick but effective negotiation of CTAs with sites.
Take Advantage of Proven Country-Specific Expertise
The Scimega team delivers consistent clinical trial start-up times 50% faster than the North American average, with trial sites often among top enrollers in global oncology studies.
With inspection ready processes and key metrics performance that clearly reflects the caliber of combined skill and service the Scimega team of oncology experts consistently delivers on its contractual agreements. This CRO works hard at working smarter every year for over two decades.
Contributed by: Chantalle Willie B.Sc., CCRP., Feasibility & Contracts Manager