Excerpt From Book: The Four Villains of Clinical Trial Agreement Delays and How to Defeat Them: Addressing CTA Delays Comprehensively by Débora S. Araujo
Introduction
Imagine with me for a moment you are your favorite superhero, charged with the task of saving the world from villains such as the Joker, Lex Luthor, Doctor Doom, and the Green Goblin. You would not be very effective—or much of a superhero, for that matter—if you only took one of them out while letting the others roam free. In the same way, as an industry, we cannot effectively tackle the issue of delays in the execution of clinical trial agreements (CTAs) by only addressing one or two of the “villains” contributing to this industry-wide problem.
In this book, we will explore the different villains who contribute to CTA negotiation delays and provide some practical ways to address each of them. By tackling the different factors contributing to this industry-wide issue concurrently, we can accelerate the change that we, as an industry, and our patients desperately need.
Lights, Camera, Action!
I know the topic of CTA negotiations may not be a sexy one for most people (except the few like me), yet it is one that can have an incredible impact in the lives of countless families. If you work day in and day out with CTA negotiations, you may not think of it as purposeful, life changing, or heroic. However, I challenge you to look beneath the surface to the compounded impact it can have for hundreds of thousands of patients and their families, both now and in the years to come. I further challenge you to see yourself as a type of superhero, charged each day with the mission of defeating the villains who could keep a dad from seeing his kid’s next birthday, a family from sharing another holiday together, or a child from enjoying just being a kid with his friends for another summer. It may seem like a bit of a stretch—maybe even somewhat idealistic—but if we don’t see ourselves as existing to make a difference, to serve and solve a problem, what is the point of our lives? I believe, even in the world of CTAs, we can make a difference.
As my favorite superhero, Wonder Woman, said, “If it means interfering in an ensconced, outdated system to help just one woman, man, or child … I’m willing to accept the consequences”[1]
Let’s do this.
Chapter 2
Villain #2 Poor Outsourced Negotiations
Villain Name: MIDDLEMAN MALAISE
With great power comes great responsibility.
—Spiderman
The right CRO or functional service provider (FSP) can be an excellent and strategic partner in helping sponsors have a wider and farther reach. This is no different when it comes to CRO-managed CTA negotiations. The CRO/FSP is an extension of the sponsor’s brand and reputation. However, CRO-managed negotiations still require a level of sponsor guidance and oversight. At times, some sponsors have viewed CRO-outsourced work as something for which they no longer need to provide oversight. This is a huge mistake that can cause weeks of CTA delays and damage the sponsor’s relationship with the site. It is vital that sponsors develop, execute, and train on an appropriate oversight strategy for all outsourced work, including CTA negotiations, and apply it consistently. Let’s explore a few options for how to defeat this villain.
How to Defeat This Villain
Leverage Existing Master CTAs
A concern that sites continue to voice is the experience they continually have with some CROs regarding existing master CTAs between the site and the sponsor. The frustration occurs when a master CTA is already in place between the sponsor and site—yet attempts are made by the CRO to use a CRO-specific contract. There is no reason to start from scratch in a CTA negotiation when the site and sponsor already have a master CTA in place. This is a contractual agreement that needs to be honored and leveraged. It is extremely discouraging to sites to have invested time in negotiating a master CTA only to not have it be used. Sponsors can help by discussing early on with the selected CRO how the current master agreements between the sponsor and the sites will be leveraged and used for the current outsourced study. This simple conversation can speed up negotiations by weeks for the affected sites.
Provide Clear Communication Pathway to Sponsor
Of course, the purpose of outsourcing work to a CRO/FSP is that the CRO/FSP is compensated for performing the tasks for which the sponsor is typically responsible. This often includes CTA negotiations. However, the sponsor is the one with the most skin in the game, remains ultimately responsible for the clinical trial, and will be most benefitted or hurt by the relationship with and performance of the selected investigator sites. It is in the sponsor’s best interest to make sure a good relationship with sites is established early in the study start-up process, even if a CRO/FSP will be negotiating the budgets and contracts and conducting the trial.
This can be done by providing selected sites with a specific contact at the sponsor for escalation of major concerns or issues during the negotiation process. It needs to be clear to sites that the CRO/FSP is conducting negotiations on the sponsor’s behalf—but that the relationship with the site is important enough for the sponsor to be involved and available. The study start-up process, including CTA negotiations, is one of the first interactions sites will have with sponsors even if through a CRO/FSP. If trust and a good relationship are not established, then difficulties are likely from that point on.
Address CRO Staff Turnover and Level of Experience
One frequent piece of feedback from sites regarding sources of delay in CTA negotiations for outsourced studies is the issue of CRO staff turnover. The issue is not the turnover itself, but rather the quality of the transition for ongoing negotiations within the CRO. Weeks can be wasted while sites try to identify a new CRO contact who can resolve the open issues and resume negotiations if the original CRO contact suddenly leaves the organization. Many times, the knowledge and progress gained through weeks of negotiations can be lost with the turnover if there is not an effective transition plan in place. This issue can be prevented, or at least minimized, by discussing and planning for resource transitions during contract negotiations between sponsor and CRO, as well as during CRO-oversight discussions.
A second concern within this topic is the level of experience of the CRO contract negotiators. Sponsors will frequently ask for confirmation of the appropriate level of experience of CRO project directors, managers, and CRAs. However, the level of experience for CRO contract negotiators is almost never discussed. During times of CRO staff turnover, this can lead to the assignment of very junior CRO staff with very little negotiation experience who lack the understanding needed for CTA negotiations. In turn, this can add weeks (and aggravation) to the negotiation process. Negotiators with strong technical experience as well as good soft skills possess golden characteristics that make CTA negotiations flow smoother.
Outsourcing CTA Negotiations Wisely
While there is not one single model that works for every situation, if a sponsor does decide to outsource the CTA negotiation piece of their study start-up, then ensuring the use of the right CRO/FSP is critical. Less experienced sponsors may believe that if all the pieces of a study are fully outsourced to a major CRO, then efficiencies will be gained in each separate task or deliverable. Unfortunately, this has not always been proven true.
It has been my experience that the best outcomes for the operational management of a trial come from ensuring each major task has the right, fit-for-purpose talent, technology, and model—specifically during study start-up. Sponsors should analyze their individual organization’s structure, culture, objectives, and talent prior to deciding what type of model to use for CTA negotiations (either in-house or outsourced models). It is possible to have an efficient in-house model for one region of the world and an efficient outsourced model for another. The important thing is selecting a model that is fit for its purpose. If an outsourced model is selected, sponsors then have the even more important duty of selecting the one CRO/FSP who will truly drive CTA negotiations forward.
If a choice is available, hire subject matter experts for CTA negotiations. Utilize either expert in-house staff or niche outsourced vendors whose expertise is focused on CTA negotiations. Don’t employ a jack-of-all-trades to handle CTA negotiations and expect negotiations to be done efficiently, thoroughly, or with high quality. It can result in hit-or-miss negotiations. Study start-up is too important to delegate to inexperienced entities and hope it gets done right.
Selecting the Right CRO for CTA Negotiations
When the opportunity arises to choose from the pool of CROs/FSPs who will handle CTA negotiations, there are a few important questions that can help a sponsor identify the best fit for this crucial study start-up task.
What is the experience of their contract negotiators? How many years negotiating CTAs?
While it is great to have lawyers negotiating contracts of any kind, clinical trial agreement negotiations can certainly be done efficiently with non-attorney staff. The educational degree level is not the most important characteristic of negotiators. Specific and robust CTA negotiation experience should not be ignored. Additionally, although there is sometimes no clear way to identify this in a resume, the people skills of CTA negotiators can make or break any negotiation.
What processes do they have in place for handling negotiations with sites that have an existing sponsor-master CTA?
This is a topic which can cause ample frustration at the sites during CTA negotiations and can easily be avoided. Sponsors must alert the CRO/FSP that master CTAs are in place to avoid having them push the use of a standard CTA agreement for a new study. It is imperative that the CRO/FSP have an established process in place with the sponsor for how to leverage existing master agreements to expedite negotiations from the start.
How will contract negotiator staff turnover be managed during ongoing negotiations?
This topic is rarely proactively discussed between vendor and sponsor, but it is a challenge that happens too often. The sponsor and CRO/FSP should develop a mutually agreed upon plan and proactively communicate knowledge and management of staff turnover during ongoing negotiations.
What is their strategy and plan for getting your CTAs executed quickly?
This question comes loaded with many others: If the negotiations will be handled globally, which countries will be targeted first? Which sites? Will they negotiate directly with all sites or have local affiliates do so? What are the specific country’s requirements for CTAs that may have an impact in the agreements being executed quickly? Depending on the answers the CROs/FSPs provide to these questions, the sponsor should be able to gauge their knowledge and experience to get the job done.
What is their CTA negotiation experience within particular countries and regions?
A CRO or FSP may be very experienced in conducting CTA negotiations in the United States and even Europe, but if participating sites are located in South America or the Asia/Pacific region (for example), sponsors need to dig deeper into the CTA negotiation experience of the vendor. The CRO/FSP must be able to appropriately articulate the individual requirements for the selected countries and identify and manage any regulatory or other applicable governing body requirements that may impact the speedy execution of these agreements.
How will site requests for sponsor involvement during negotiations be managed by the CRO/FSP?
No CRO or FSP wants a site communicating directly and solely with the sponsor for CTA negotiations if the vendor is being paid to accomplish this task. However, at times, sites may have legitimate reasons to speak with a contact on the sponsor side. This can happen when negotiations are at a standstill or if the site feels the manner in which negotiations are being handled by the vendor is not appropriate. While no one wants this to happen, it is important that the selected CRO or FSP clearly understands from the start that the investigator and/or site representative should always be provided with a contact at the sponsor if the site desires such information. CROs and FSPs are an extension of the sponsor’s brand, and the ease with which they supply contact information during the start-up phase will set the tone for the entire study.
Will a summary of changes approved during negotiations be provided to the sponsor, along with the final CTA version, prior to the full execution of the agreement?
When sponsors hire a CRO or FSP to handle CTA negotiations, time can be lost at finalization if the sponsor does not have a clear understanding of what language or terms were agreed to during negotiations. It is extremely helpful when a summary of approved items is provided to the sponsor prior to final signatures. This way, the sponsor signatory can ensure that the final document only contains items that are within the parameters of the organizations’ policies, without needing to hold the document for days to review it line by line.
How will metrics and issues during CTA negotiations be communicated to the sponsor? What will be the frequency and method?
Whether via a weekly call or tracker, communication of negotiation status and issues, on a site-by-site basis, is a must between sponsors and CROs/FSPs negotiating clinical trial agreements. Sponsors can use such calls to discuss any pain points or reoccurring themes, confer and potentially develop clearer negotiation parameters based on CRO feedback, or escalate issues or concerns that may threaten the study start-up process. Issues that are not communicated are rarely resolved and often must be revisited during study conduct.
What is their reputation among sites?
This one is tricky. While everyone one has a bad day, a bad week, or even a bad year, consistently negative feedback from sites on a particular CRO/FSP or other vendor should be a red flag for sponsors during the vendor-selection process. Feedback can be either formal or informal, but it should be taken under advisement and careful consideration when selecting who will represent you as the sponsor in CTA negotiations for outsourced trials. Continue reading…