In Part 3 of this study start-up series exploring reasons for Site activation delays, ICE Global Consulting’s Head of Site Readiness, Maria P. Ladd, digs into the complexities of the delay loop.
How Do We Solve for the Factors and Whys?
Part two of this series, Delays in Site Start-Up = Delays in Study Results, drilled into some of the details for common reasons of Site activation delays among Sponsors, CROs and Sites. While all sides of the equation have unique challenges to overcome, the standard operations among these amalgamated study teams does not acknowledge nor address resolutions to the unique individual challenges, which can impact the overall goal. And as simple as a solution may seem – it’s complex when thinking of three types of organizations with their own standards and practices. Each will naturally have its own goals, not to mention varying processes and standards.
In this wrap up of the series, we look at these perspectives and ask what is really needed within the broader study team and how might we identify and resolve some common issues?
What’s Happening Broadly?
Much to the chagrin of Sites, CROs and Sponsors often adhere to industry standards not rooted in regulatory requirements. As time has moved on, it seems we’ve taken one of our industry’s strengths (assessing risks) and have created a weakness – we’re so risk averse that we attempt to avoid every potential question that could ever be asked regardless of how likely it is, or not, to be raised. Or we have not planned for providing explanation or supporting rational if it is asked. Risk aversion is healthy and needed but when it becomes a snowballing stumbling block, progress slows to a crawl. When we take the route of continually adding unnecessary processes and requirements, we essentially get in our own way and prevent the goal we all seek – timely Site activation. The reasons for this can be from either negative past experiences or study team members who are new to the clinical research space.
Sometimes, even with the best of starts, things can go wrong; without cool heads looking at all of the information, the situation can turn counterproductive, not getting to the root of a problem. It isolates people and exacerbates whatever the issue is, invariably also slowing down progress. In a culture of underlying anxiety, people on the defense may be less collaborative as well as less likely to prioritize for the common goal as they focus on a perceived need for self-preservation. At the end of the day, people are people and may take others’ actions personally and respond in what they perceive to be like kind. If the hole gets too deep in this space, it is difficult to dig out and the study goals are hugely at risk.
There will always be the need to resolve issues – problems will arise and will need to be managed for everything from selecting the best Sites to getting all tools and supplies where they need to be, juggling delays with submissions and reviews, etc. Projects need to be managed, logistics need to be coordinated and organized. Ultimately, this is the job of all of the team members and each role plays a critical part – if this weren’t true, most of the teams and roles would not be needed or used. The team is put together to solve problems that are anticipated and expected, with an expectation that in the fast pace of Site start-up, unforeseen challenges or issues can be quickly identified and addressed.
What Are the Individual Challenges?
Every organization has issues to overcome which may impact its work; as with other industries, these ebb and flow for Sponsors, CROs and Sites. Acknowledging that problems exist is the first step to solving them. Understanding the issues, working to correct and avoid them, and not getting trapped in the blame-game from the other side of the fence are steps each entity can take to improve its own landscape and work together as a team.
Sponsors and CROs have a wide-angle lens with an entire study to run and many interdisciplinary teams to manage – and the larger the study, the higher the risk of the various teams losing sight of what the others are working on and encountering, even those internal to one another.
Sponsors have an unparalleled responsibility and investment in the studies; from a single compound or device for smaller companies to working toward multiple, sequential projects for
larger ones. Large pharma and device organizations may have the resources to support several aspects of a clinical trial, keeping the need to outsource down, however, smaller companies
generally need to outsource to a service provider for most or all of the research components. In any case, the Sponsor arena is years in the making and by the time it makes it to vendor relationships for doing clinical research trials, they are living and breathing what is now a new project for the vendors. If a Sponsor team is experiencing heavy expectations from senior and executive management, the mindset that applying intense pressure gets results may take hold and become a factor vendors feel they need to manage.
The time and financial investments are enormous for the Sponsor and there are many high-level layers of leadership and financial investors monitoring the progress of the study. The time it takes to get to the regulatory approvals and then Site activations is lengthy, and a void may be felt until some of the first milestones are reached. At this stage, there is a temptation to have vendors work on tasks that do not actually move the needle but appear to be taking action, not actually netting real progress. Whether or not that is worth the time and energy for the study may be outside of the reality that sometimes it goes a long way toward easing anxieties within the Sponsor team.
As a vendor, it can be a challenge for the CRO to accommodate and please the Sponsor client, especially if they do not know or understand what underlying obstacles are occurring for them. CROs, not wanting to be perceived as weak or seem that they do not know what they’re doing may, in turn, be slow to reveal the challenges they face to their Sponsor team.
CROs sometimes perceive that their advice is not taken or is slow to be taken, creating gaps that need to be factored into timelines already in place. CRO teams are usually working around delays that happened in stages prior to their being chosen but more often than not, the request is to meet the original timelines despite these earlier delays. It is the CRO’s function to put strategies in place which mitigate the challenges, remove the obstacles for study success and seamlessly drive toward the timelines put before them. The ‘tightrope’ effect leaves little room for unavoidable and unforeseen issues such as regulatory submission delays or time-intensive regulatory responses received. If a CRO works with a Sponsor team not well-versed in the mechanics of the clinical research space, that Sponsor team may either leave the CRO to run those services without robust oversight or, fearing what they have heard from colleagues, micro-manage the process. Either of these come with challenges that can cause gaps or impede the process and the end result would typically be the same in generating unintended delays.
Site networks have an advantage of seeing study work across multiple locations, somewhat similar to the larger-scale view of the CRO and Sponsor. A solo Site has a more limited view of the study landscape, narrowed by one perspective and what their CRO and Sponsor contacts share. In this space, the focus will be on what one Site needs for the study, more so than where they land in the scheme of the study metrics. Their positioning may have a strong impact for enrollment as a part of the whole study target, vital for the Site and for the study – but they may not even be aware of that position.
Sites in general often feel a hurry up and wait – urgent requests to get things done quickly, then silence – and suddenly back to urgency. How they are doing, what their standing and position is, how they are measured for performance, and many other pieces of critical information, and historically is usually not information Sites are given or feel they have any visibility into. Training for how to run a study and interact with the Sponsor and CRO is rare for Sites; basic administrative needs and knowledge for clinical research studies may not be a part of the Site infrastructure or provided by the Sponsor or CRO. In an outward concentrical system, there are various bodies contributing to the Site work, but which get further and further from the study action. Multiple internal committees, the Site’s legal and contracting teams, etc., may not have the same drive for individual study goals, creating a tremendous impact on the Site’s activation timing.
Skeletons in the Closets
Clinical research is a tough industry to be in, no matter what company you work for. Just as each organization does tremendous work to be proud of, progressing therapies for the better health of human beings, no entity is without its own brand of Achille’s Heel; there is typically some level of validity behind the various reputations and notorieties. Human beings will make mistakes – and there are more ways for study events to take an unpredicted turn than there are studies it happens to. It’s a part of the process and why we need all of the varying teams of people to coordinate and collaborate for success. One common theme worth mentioning across companies involved in clinical research is the propensity to forgo a work/life balance; sometimes it’s the underlying work culture of an organization. And what used to be practices of doing so leaning toward being US-centric, has spread across the globe in an ever-widening circle. Teams push one another and individuals push themselves – contributing to the frustrations, finger-pointing and divide across individual contributing organizations.
No, Seriously – What Should We be Doing?
Communicate; it’s difficult to know what the challenges are if they are not expressed. Most people thrive in a challenge much more readily if they know at least part of the ‘why’ behind it – it simply makes it more relatable and easier to achieve. Share information – and share the why, create an atmosphere of transparency.
Strive to understand and address the pain points of the teams external to your own, especially if they come from a perspective others have of something that you could have done better. Working to reduce the issues of other teams will inherently reduce one’s own pain points and frustrations. When an upstream or downstream collaborator understands that their challenges are heard and there is a partnership for resolution, even difficult tasks become less stressful and more easily dealt with. Take responsibility and be accountable for actions and then work toward resolution, this requires that every group look inwardly and be open to feedback about the areas that need improvement.
This is Change Management at the core – we need to be open to change, willing to change and hold one another respectfully accountable to change, all in equal parts. We need to leave our egos at the door because we have a much larger mission at hand. Having Sites activated without needless delay, enrolling sooner, getting data sooner and therapies to market sooner – it’s all connected.
Conclusion
In many ways, the answer is within a well-known parable, summarized here: A Rabbi visits Hell and then Heaven – everyone in Hell is at a table full of food but they have only long spoons to eat with and no other way to get the food; no one gets fed because they cannot reach their mouth with the too-long spoons. The Rabbi then visits Heaven where there is the same scene – a table full of food and only long spoons…but the people there feed each other across the table with the long spoons, working together to get fed. It’s a simple tale, one which reminds us that everyone has challenges, but how these are approached and the willingness to work together are the keys to success. Obstacles in the Site start-up process are best resolved as a unit and doing so does not diminish our organizational goals, it ensures reaching those goals, and the success of each individual organization.