Halloran Consulting Group launched CORE East over two decades ago - a Clinical Operations Retreat for Executives - which is an invitation-only meeting that brings together an exclusive group of senior leaders in clinical development to discuss and debate the most pressing issues around the business of product development and building enduring life science companies.
Because of the success of CORE East, Halloran recently wrapped its second annual CORE West. The event was filled with expert speakers and active and engaged attendees discussing issues and opportunities together. The environment has been described as a three-day therapy session because of the closed-door environment, the community feel, questions are openly asked, and answers are thoughtfully shared. One of the big topics discussed this year was turnover.
The discussion of turnover - part of a larger discussion at CORE West by David Turner, Chief Strategy Officer at ScienceMedia and Bruno Gagnon, Senior Vice President of Development Operations at Eidos Therapeutics - was folded into the panel "How Protocol Compliance Management Can Support Adaptive Clinical Trials Through Education and Technology."
Protocol Compliance Management (PCM) is quite useful and helps solve for the operational and protocol compliance challenges clinical trials experience due to turnover by providing clinical trial sponsors with the tools and technology to mitigate the risks associated with turnover. In this article, we will build upon the event's panel topic and explore how PCM can positively impact and speed up clinical trials amongst this 'great resignation' where turnover, protocol compliance, and proper training are major concerns but opportunities for operational success with the right approach.
The Great Resignation and Clinical Trial Site Turnover
Large numbers of employees began resigning from their jobs in early 2021 resulting in what's referred to as 'the great resignation' - a result of the COVID-19 pandemic enabling employees to prioritize their mental and physical health, rethink their professional growth trajectory, and leave jobs and try something new. This massive resignation left almost every industry with employee retention challenges and immediate gaps to fill in their teams.
The life science industry has not been spared from talent retention, and along with a loss of more experienced talent, new life science jobs continue to become available to meet the demands of scientific research and clinical trial operations, which puts a large burden on in-house training resources. This evolving mix of loss and opportunity has led to an ongoing talent gap, making employee retention and turnover a critical concern because of its impact on operations, budgets, and training.
Turnover is inevitable, though. ScienceMedia's CEO, Mark Surles, mentioned before this event that "the biggest concern at sites today is staff turnover. With rapid turnover and understaffed sites, clinical trial protocol compliance management becomes crucial to efficiently managing clinical trials. Staff need to be onboarded, they need to be trained efficiently, they need to remain compliant with the protocol, and they need a central platform to reference daily as they see patients."
But as we look at turnover at sites and clinical research organizations (CROs) in various stages of the trial's operations, the question becomes 'how do we ensure new employees don't jump in and make a costly mistake later on in the trial protocol that may lead to protocol deviations and reduced data quality or worst case, patient safety?' The protocol is the document that describes how a clinical trial will be conducted and ensures the safety of the trial patients and the integrity of the data collected.
Having professional training ready at all times will make retraining new individuals much easier and with compliance, will shorten the learning curve which makes employees and their teams more productive faster, and will help reduce the turnover pain felt by those in-house by having tools and consistent training in place at all times.
Protocol Compliance Management (PCM) and Its Application
Staff turnover is going to happen at any stage during a clinical trial, and so is the value of ensuring new hires follow the trial's protocol to avoid costly and timely mistakes. This dynamic is why ScienceMedia's SMi Trial - their PCM tool - was designed so they could help sponsors and CROs transition to online clinical trial management by facilitating global communication and monitoring of sites, circulating protocol training and study updates, and deploying comprehension assessments to identify the high-risk areas of trials without requiring on-site visits.
Though protocol training may be provided by a sponsor or CRO, that doesn't necessarily mean it equates to protocol compliance management, which is a more holistic process established throughout the entire trial through an interactive multimedia format with built-in knowledge checks to ensure data quality and reduce protocol deviations. When compared to standard protocol training which is typically a one and done death by PowerPoint at the start of the study, protocol compliance management is a more proactive, consistent, and a continual risk-based approach throughout the lifecycle of the trial.
Additionally, gaining access to real-time, high-risk information on the disease state or therapeutic area of the trial can often be a challenge for sponsors to continually acquire, which is why utilizing PCM to provide that support can reduce the burden on the sponsor especially if a key employee leaves the organization. SMi Trial is backed by clinical and medical experts with deep experience that propels the training and educational tools. Gagnon shared "appropriate training on eligibility criteria and a focus on common reasons for screen failure will improve chances for a sponsor to meet or exceed enrollment goals. This may allow sponsors to adapt tactics, and even in some cases, make critical decisions about protocol amendments."
A large, global pharmaceutical organization identified one of its investigational CNS drug programs as "the future of the company." The program's multi-arm, Phase II trial was jeopardized by enrollment errors and protocol deviations despite the deployment of hands-on site training. The sponsor selected their CRO to help mitigate these risks in their upcoming global Phase III study. In order to scale the trial globally and ensure the quality of the clinical data, the CRO implemented SMi Trial™ and exceeded the sponsor's expectations.
Phase II Challenges
High placebo rates requiring hands-on site training that would be impossible to implement globally
Errors in subject enrollment into each study arm caused by misdiagnosis of disease subtypes
Mistakes in dosing, timing of interventions, and measurements as they varied by visit and study arm
Phase III Expectations
Complete study six months sooner
Reduce subject costs
Prevent protocol deviations
Standardize compliance across 142 global sites and 40 CRAs
Ensure clinical data quality
SMi Trial allowed study teams and site staff to learn on their own time and at their own level, which greatly facilitated the understanding of the therapeutic area and the protocol. This training improved comprehension and the consistency of messaging and ultimately led to better study conduct.
FDA and EMA Approvals Ahead of Schedule
Trial completion six months early
Deviation rates in the top 10% of all studies conducted in the CRO's history
$100,000s saved in downstream monitoring and additional time-to-market opportunity costs
Significantly lower placebo rates
No adverse findings in audits of training, protocol compliance, and patient protection
No regulatory issues after multiple site and sponsor inspections
How PCM Enables Operational Efficiency Amongst the Great Resignation
New staff need to be onboarded, trained efficiently, remain compliant with the protocol, and they need a central platform to reference daily as they interact with patients. Turner stated "what might initially be perceived as a simple two arm study, can quickly turn into many dozens of documents and hundreds of regulatory records that each site staff, including newly hired staff, is required to consume. There are protocols for each arm, an investigator brochure, plus documents for pharmacies, labs, imaging, randomization, and data capture. These can be in multiple languages with reoccurring amendments." That is a lot of documentation, and of course, the need for site staff to be compliant to the protocol at every step to ensure accuracy of all that is required.
To aid with turnover frustrations and gaps in new hire expertise, SMi Trial acts as a central resource for all staff from start to finish, provides compliance records, and supports sites operating in multiple countries. Bruno Gagnon commented "appropriate protocol training will improve chances for site staff to adhere to the protocol and properly treat patients and reduce reasons for patients to discontinue participation or withdraw consent." This PCM tool also actively trains sites at start-up and serves the entire clinical trial lifecycle, ensuring that each site is compliant with the protocol through amendments, staff turnover, and onboarding new staff.
Gagnon further added "I see this more as a tool to re-train new resources quickly (at the site, CRO, and sponsor). It's all about data quality. If you have better protocol compliance, you'll have less deviations and less data queries and spend less effort cleaning up the study in anticipation of database lock."
Adequate training on unique study procedures is critical to study success, and with turnover here to stay, the need for PCM and SMi Trial becomes more and more important to ensure safety and compliance. Training becomes easier and reduces the burden on those already in-house to do the training, and by design, sets up an entire team for success by empowering their staff with the right tools and training to do their job at any time.
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About CORE West
CORE East, the Clinical Operations Retreat for Executives, was launched in 2004 and is an invitation-only meeting that brings together an exclusive group of senior leaders in clinical development to discuss and debate the most pressing issues around the business of product development and building enduring companies in this space. Following the success of CORE East, CORE West was launched in 2021 with the same mission.