By Dana Fletcher, August 18, 2016
You’ve heard the story before. FDA has approved the protocol. The sponsor has contracted with a Clinical Research Organization (CRO) to initiate and manage their clinical trial sites and electronic data capture database. They’ve done everything in their Clinical Standard Operating Procedures to start their new trial. Then they start seeing delays with IRB approvals and enrollment. They start having to increase the time spent on site visits because some sites are having problems and need additional training. Because of the delays, management decides to add more sites, which may include a protocol amendment. The original deadline for study completion blows by and the budget explodes. What happened?
This is an example of scope creep.
Scope creep is a project management term for uncontrolled changes or continuous growth in a project’s scope resulting from lack of proper definition, documentation, or control in the scope. In Teamgantt’s blog, “Scope Creep – The Two Dirtiest Words in Project Management”, Sandy Stachowiak describes scope creep as when a client, co-worker, or customer requests an update or addition after the project is underway, especially without a commensurate change to timeline, budget, or resources. She suggests three things to prevent scope creep: spell out the entire scope before the project begins in a scope statement; impose financial penalties for changes; and put changes into a new project request for later.
Certainly, these are all good practices, but perhaps not a complete picture of what went wrong in our clinical trial example. Let’s dig a little bit deeper into what is really going on with scope creep in our example, and how to prevent these specific risks for creep.
Early in the project, identify conservative, yet realistic expectations for investigational site factors that drive the time required to complete project goals.
In our example, understanding the detail of investigational site workflows and processes could have allowed the sponsor to set goals for IRB approval and contracting to reflect more accurately how long these processes would take at each site. Many times, the vetting process assesses the processes at each potential site only superficially. To circumvent this problem, spend more time up-front than might be expected in vetting potential clinical sites. If a key site has prolonged process times, either build that into the timeline, or if possible, consider replacing that site with another, more agile one.
Courtesy of www.ricohidc.com
This goes for enrollment capacity as well. Spend additional time and resources with each potential site during the site qualification phase to understand the practice volume of the target patient population, other clinical trials that may compete for patients, site coordinator expertise and availability, and investigator availability. These things, as well as the likelihood that a given patient will agree to enroll in a given study, are all key factors to pay close attention to prior to finalizing your research site list.
Spend time on the front end estimating potential site problems and variations in management time.
Sometimes even the most thorough site qualification process can’t predict all the problems a particular site may face. Sites may have personnel or policy changes that create unanticipated challenges for enrollment or compliance. Understanding site management time and potential variation in that time is critical to building timelines and budget on the front end. Stan Reaves, Chief Operating Officer for Hart Clinical Consultants, says, “There needs to be a mechanism to determine site issues/workload during negotiations rather than getting through negotiations and then finding more work than originally discussed.“ Build enough leeway to the budget and timeframe to address problems adequately as they arise to minimize delays and budget creep.
Establish a well-planned fee structure/budget design.
CROs each have preferences for different fee structures. Some will prefer a flat fee rate for visits and others will prefer an hourly rate. If a sponsor leader understands exactly what it takes to conduct a site initiation, monitoring, or closure visit, and the variation that occurs with different sites, an hourly rate may be preferable. However, a flat fee or block pricing may be preferable for communicating a fair price with CFOs and other non-clinical leaders within the sponsor company. Jim Hart, CEO for Hart Clinical Consultants, prefers block pricing in these cases, and says, “A CFO or other sponsor leader may not understand fully the time it takes to conduct a site initiation visit, for example, and may prefer to see a simple visit rate for completion of that required block.” Have thorough conversations about pricing structure and budget design to make sure it fits the circumstances for both the sponsor and trial.
Nurture a healthy business PARTNERSHIP.
Courtesy of jeff-alexander.com/
One mistake our example sponsor may have made was to hire a CRO and then forget about it–with a “pitch it over the fence” kind of mentality. Developing a partner relationship with a CRO that is based on open and detailed discussion will result in a smoother operation, with fewer delays than one without a proactive, honest, and open team culture. Sometimes this means dedicating a staff member to manage coordination and oversight of the CRO. Prior to contracting with a CRO, it is critical to consider which CRO fits best as a teammate and has a similar organizational culture. The strongest team is the one that can pull the rope in the same direction.
Have regular and honest conversation.
While this last point may seem redundant, it is important enough to stand alone, and may be the most important thing one can do. We cannot emphasize enough how important it is to have frequent, meaningful conversations. Beginning with the first encounter with any team member or vender (e.g., CRO, investigational site staff, sponsor staff), it is imperative to create and maintain a culture where both successes and challenges can be discussed honestly and openly. Teamwork and integrity enhance the cohesiveness that leads to proactive identification of problems and potential delays. The goal of the team should be to limit surprises during the course of the clinical study. As Steve Jobs once said,
“Great things in business are never done by one person. They’re done by a team of people.”
The theme that flows through all of these recommendations is that a successful clinical trial with minimal scope creep relies on a pro-active culture and commitment to spend the time and resources up front. Identify, at a meaningful level, who your best teammates will be: from internal staff to investigational sites to your CRO. Do not skimp resources at this stage: companies have been made and broken by their planning or lack thereof for their clinical trials.
Courtesy of franksonnenbergonline.com/
Some scope creep is bound to happen – by planning ahead you can limit the frequency and severity. When potential delays or risks for delays are discovered, have the conversation early to remedy the possibility for downstream expansion of scope. The only way this happens is if that healthy partner relationship is there. The only way that such a partnership is nurtured is via regular and honest communication.
We believe that at Hart Clinical Consultants, this is what we are all about – getting to know our clients and their needs and putting our cards on the table to make sure they know us.
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