Reframing Rescue: Reinforce Your Clinical Trial Instead Of Rebuilding It
By Raul Lima, inSeption Group
Trial “rescue” is an emotionally and operationally loaded term that implies a complete do-over, sometimes replacing vendors, finding new sites, or purging sponsor personnel. Such rescues often mistakenly treat symptoms of the problem rather than provide cures for root causes.
Scaffolding, in the context of clinical trials, is a strategic alternative to trial rescue that enables sponsors to identify and address gaps in internal infrastructure without eliminating elements that performed adequately or restarting the entire study. The most effective solution is targeted reinforcement rather than a complete overhaul, ultimately optimizing performance without creating disruptions and adding costs that can derail timelines and financial goals.
Is Your Protocol Designed To Fail?
When a clinical trial goes askew, finger-pointing, assumptions about what went wrong, and generic fixes can damage the trial as much as the problems that initially undermined it. That is why a sponsor and its partners must diagnose the root cause of the trial’s failures rather than focusing on symptoms, such as low enrollment or excessive change orders, that often mask deeper structural or technological misalignments.
These occurrences are usually the business realities of poor planning manifesting themselves symptomatically through flawed operations, added cost, and an extended timeline. To discover the root causes of such issues, sponsors should begin by scrutinizing their protocol. In our experience, at least two-thirds of derailed trials can be traced back to protocols that, while scientifically sound, lack proper regard for the variables of real-world operation.
Rather than consider how endpoints and their collection will interact within a series of practical settings, many protocols are crafted with an eye toward conceptual, perfect settings. But the unpredictable lives of patients and sites that all operate differently will inject numerous unknowns into an already complex endeavor. Additionally, there are substantial differences between the operations of a small community clinic versus a sprawling, university affiliated medical complex, and it is often the case that similar-sized hospitals differ greatly from one another in terms of day-to-day operations. This leads directly to cost and time overruns, since more site effort than anticipated may be required to execute the protocol or patient burdens may exceed what patients consider reasonable.
When inSeption Group has “rescued” studies, we did not see a significant impact because we changed vendors, sites, or management. Instead, reevaluating early decision-making and engaging with trial operations differently was the most effective strategy ― and that starts with reexamining the protocol.
Is Anyone Helping Sites Do The Heavy Lifting?
Trial sites are the second key element in diagnosing where a clinical trial went wrong and correcting course. Patient-centric care has become a cultural and operational priority for sponsors, but site support — a key enabler for patient comfort, convenience, and well-being — is an often-forgotten element of that equation.
The way sites operate has changed drastically in the past two decades, but the industry has been slow to adapt its protocol-writing mindset for modern hospital operations and EMR environments. Hospitals generally are composed of dissociated departments, with infrastructure designed to support throughput rather than research. Modern EMRs are built with the same mindset and are not necessarily designed to record data for clinical trials, making it difficult for sites to enter data.
When problems start to pile up, sponsor leadership may feel like its sites (or monitors) are not performing their jobs well. However, it is more likely that the sponsor did not have adequate ClinOps expertise to inform trial operations and oversight. In some cases, clinical scientists and functional leads are being asked to serve as architects of trial execution without proper training or tools. While sponsors may expect their CROs to identify gaps, a CRO’s mandate typically is to execute the protocol as-is, not to analyze and report its issues.
This situation is exacerbated by CROs whose business models are designed to create efficiency for the vendor, often at the expense of sites. The result is vendor tasks that are broken into small pieces and disseminated to specially trained associates who can complete those tasks at high volume. This assembly line mindset does not serve clinical trials well for two reasons. First, this approach shifts responsibility and complexity onto sites that are not equipped to handle either. The sites usually lack a central contact and reaching out to the CRO for guidance often results in a run-around, trying to find the right department — an extremely frustrating bottleneck for time-constrained site personnel.
Second, clinical trials are only becoming more challenging as the industry transitions from larger-scale trials with limited endpoints to personalized/advanced medicine clinical trials laden with the collection of numerous endpoints. Managing this growing complexity means partnering with even more vendors and communicating with more departments. Simultaneously, the teams of HCPs treating patients and entering data at sites are shrinking, even as their responsibilities grow. Sponsors tend to underestimate the implications of this data infrastructure complexity on these already overburdened teams.
For example, if a trial calls for testing of multiple different biomarkers, those tests may be headed to several different labs. If each site has to oversee the logistics for each individual lab, filling out all the forms and carefully packaging the materials, how does that impact those HCPs’ ability to perform their core responsibilities without error? Also, how does that workload influence the site’s desire to participate in the clinical trial?
If your trial is exponentially harder to execute versus a competing trial, sites generally will prefer to enroll patients in the latter. Thrusting unnecessary complexity and responsibility into the hands of sites injects risk into the trial. This is a pervasive problem in the industry: prioritizing simplicity for sponsors, often by hiring multiple vendors while overlooking the crucial benefits of streamlining processes for site personnel who may be overworked or distracted. The fundamental issue is a lack of centralized ownership for the project. With numerous people managing diverse tasks, the lack of a designated leader can result in misdiagnosed clinical trial problems and the implementation of ineffective solutions.
Who’s On First?
Abbott and Costello’s classic comedy routine about baseball players with confusing names is an apt comparator for the uncertainty about who takes ownership of specific clinical trial elements. Effective trial support requires mapping not just tasks but also people and their capabilities, which can provide insight into where communication gaps may exist.
Clinical teams often lack individuals capable of aligning protocol design with operational execution and technology capabilities. They may also frequently lack “translators” who can effectively bridge communicate gaps and convey problems or needs between the sponsor, CRO, vendors, and sites. Empowering those individuals and teams leads to tailored solutions, rather than generic ones.
Common sense dictates that, if you want to know what is happening at sites — and, by extension, identify where additional support would be helpful — you do not ask the CRO talking with the PI. Instead, you speak directly to the study coordinators, the treatment nurses — those who collect and enter study data.
Hire a dedicated ClinOps overseer or a CRA who is not tasked with routine monitoring, and then appoint them to oversee study sites and forge relationships with the trial personnel. This role facilitates the collection of accurate information about trial execution, circumventing the “politically whitewashed” version that can emerge when a PI is seeking updates.
One question you may consider is, “if I hire vendors, why do I need internal people?” The answer is analogous to why a construction site needs a foreman, despite employing experts in carpentry, concrete, and roofing. Designated overseers create accessible hubs for information and accountability throughout the trial. Sponsor ClinOps teams sit in the center of the clinical trial web, maintaining relationships with vendors and sites while also reacting to early indicators of problems emerging around the edges.
Boutique CROs and consultants can then fill critical gaps through flexibility, strategic integration, and deep expertise that large CROs tend to lack, either in capability or desire to engage. They offer an objective viewpoint on whether problems stem from bad technology or its misuse; unsuitable personnel or inefficient training; or underperforming vendors or inadequate support.
The scaffolding strategy enables ClinOps comprehensive visibility into trial operations and speedy access to any part of the study requiring attention. This is achieved by surrounding a clinical trial with structure that simplifies problem identification, clarifies the skillsets necessary for resolution, and ensures the right personnel or teams are assigned to the task. This is not to say all trial activities proceed perfectly when scaffolding has been established; however, this approach establishes a group of well-supported people capable of quickly comprehending and responding to what is happening in the field.
The Scalpel > The Wrecking Ball
If you are not treating root causes, you have not fixed your trial’s problems; you have just made yourself feel good about doing something. Without knowledgeable ClinOps and an established structure that promotes data-based operational introspection, sponsors are more likely to bring in new vendors and sites that are naïve to the problems experienced by the previous ones, leading to the same problems in a new vendor.
Implementing a scaffolding strategy improves alignment between the protocol and the people involved, benefiting the CRO, sites, and the patients (and their families). This is imperative, especially for complex clinical trials in areas like rare diseases, oncology, or novel designs, which frequently require continuous adaptation during the study. Scaffolding helps every stakeholder to better understand a protocol’s practical implications, as well as provides flexibility and mechanisms to implement midstream changes. It empowers sponsors to proactively address red flags instead of reacting only after problems have occurred. Ultimately, scaffolding is an effective vehicle to route any setbacks directly to the people who are best equipped to resolve them. They can then resolve the most pressing issues, determine the root causes, and take decisive corrective actions before a more complex “rescue” becomes necessary. To learn more, contact the author and visit https://inseptiongroup.com.
About The Author
Raul P. Lima is Executive Vice President of Clinical Operations at inSeption Group. He is a proven leader in clinical operations with over 25 years of strategic, tactical, and hands-on experience in the management of global, multi-center clinical trials. He has extensive experience with timeline, clinical trial budget, and people management, and has successfully led cross-functional teams, including at Sponsors and CROs. Raul has repeatedly executed strategies ensuring that clinical operations activities supporting clinical trial management are conducted effectively and efficiently, are quality-driven, and comply with all applicable regulations. He possesses an uncanny vision and expertise in communicating that vision to influence strategies that progress cross-functional projects, as well as an unwavering passion for championing development.