Managing Clinical Trials: Navigating Challenges and Ensuring Success, interview with Helen Johansen Blanco, COO of Node Pharma
In the world of clinical trial operations, effective management and oversight are crucial for success. Helen Johansen Blanco, COO of Node Pharma , shares her extensive insights on identifying underperforming partners, making tough decisions, and turning around struggling trials. Her experience offers valuable guidance for sponsors and clinical research professionals navigating the intricate landscape of clinical studies.
Recognizing Red Flags
Early identification of potential issues is key to maintaining the integrity and progress of a clinical trial. Helen highlights several red flags that may indicate a CRO (Contract Research Organization) is underperforming:
"Examples of red flags are signs of insufficient resources or lack of prioritization of your project," Explaining, "This could manifest as getting the 'C team' - unexperienced crucial team members, not showing up for meetings, consistently late deliverables, or lack of quality in deliverables."
She also emphasizes the importance of a healthy working relationship and the potential issues with poorly established CROs or vendors. "A strong blame culture and lack of solution-oriented behaviour" are additional warning signs to watch for.
Helen stresses the importance of proactive monitoring: "These are all indicators that a sponsor can pick up prior to a CRO starting to underperform and hence choose to improve the situation before it affects the study too much."
Measuring Performance
To objectively assess a CRO's performance, Helen recommends establishing clear metrics from the outset. "The underperformance in itself is measured by a set of standard Key Performance Indicators (KPI) agreed at the start of the trial and monitored on regular basis, e.g. monthly". She adds: “It is important to ensure a broad set up KPIs, including all functions involved in the clinical trial and crucial for the outcome, as data management, monitoring, project management, finance, regulatory, medical writing, contracting etc.”.
Making Tough Decisions
When faced with underperforming clinical sites, sponsors must carefully weigh their options. Suggesting a proactive approach: "In many of the projects I have been involved in, we have identified a list of sites at start, priority sites, but also a list of back-up sites. This enables a quick replacement, and limited effect on the recruitment."
She elaborates on this strategy: "Back-up sites have been part of the CTA/EC submission, but are not activated unless one of the 'priority sites' needs to be closed due to e.g. lack of recruitment. This enables a quick replacement, and limited impact on the study. It also puts a certain pressure on the 'priority sites' activated from start, as they know that we have a back-up plan in case they don't recruit to our trial."
However, she cautions that the decision to replace a site isn't always straightforward. "It is neither the minor hiccups nor necessarily the serious issues that warrant a change," Helen states. "It is important to have a holistic overview of the performance from the start and continuously during the project and look for the trends and ability to learn from mistakes and the continuous improvement."
Balancing Risks and Benefits
When considering a switch in vendors or CROs, Helen emphasizes the need for a comprehensive risk assessment. "A proper Risk assessment needs to be completed prior to considering a switch, including all the functions involved, not only clinical operations, but also data management, medical writing, medical monitoring, contracting etc."
She adds, "It is important to have a holistic overview what can cause study failure, not the data inconsistency in itself."
Stressing the importance of proactive risk management: "During the early risk assessment, it is important to identify the risks that you can mitigate upfront and once they become an issue, track the actions to be taken by the team for a prompt resolution."
Minimizing Disruptions During Transitions
If a change becomes necessary, Helen recommends strategies to minimize disruptions:
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"To minimize disruptions during a transition between two CROs or vendors, I prefer to set up the handover meetings face to face as far as possible," she advises. "There should also be a face to face handover between each function (data management, medical monitor, project management etc) as far as possible."
Emphasizing the importance of maintaining professionalism during transitions: "It is important that the handover is done in a neutral way, no blaming and no disrespectful communication of the vendor or CRO going out. Attempting to use a 'neutral' reason for change is the best, e.g. expanding to countries outside the reach of the current CRO or similar, to avoid focusing on non-performance."
Timing of Changes
Regarding the timing of major changes, Helen offers a nuanced perspective: "Changing after database lock makes little sense. If you are at the very end of following up your patients for overall survival, it also makes little sense." However, she adds, "If there are crucial deliverables that are at high risk of failing, you still have the option to adapt your outsourcing model accordingly, but not necessarily fully change, for instance outsource the medical writing of the CSR to an independent consultant."
Her philosophy is that "it is never too late to change," but she advocates for a flexible approach: "If a proper oversight model is built in from start, including a wide variety of KPIs and a governance structure, you will be able to pick up the signals early on. This decreases the impact the change has on the study."
Balancing Quality, Timelines, and Budget
When it comes to weighing the impact on timelines and budgets against the need for high-quality data, Helen recommends a balanced approach to Key Performance Indicators (KPIs):
"When setting up your Key Performance Indicators, that you will use for monitoring of the performance, it is important that it includes deliverables that will impact timelines, KPIs related to budget adherence (change order frequency, reporting of accrued work at CRO on monthly basis etc) and quality aspects (both from a data management perspective, as query resolution time, number of queries, errors found during statistical dry-run, but also from a Quality Assurance perspective as number major or critical audit findings, issue resolution time etc)."
She suggests a balanced approach: "A 'rule of the thumb', is to have an equal amount of KPIs within each area (finance, QA, data management etc), for a fair assessment."
The Power of Proper Oversight
Sharing a success story where effective governance and the use of Key Performance Indicators (KPIs) helped turn around a struggling trial without changing vendors:
"While running the T-Cell lymphoma trial with Revlimid at Celgene, we had major issues with performance at the CRO," Blanco recounts. The root cause was identified as poor project management within the CRO. Through a series of interventions and open communication with the CRO's management, including escalation to the CEO level, they were able to dramatically improve the situation.
The turning point came when the Head of Project Management at the CRO took personal responsibility for the project: "This worked absolutely fantastic: the TMF quality improved drastically, deliverables were completed on time and they even caught up with some of the lost time in the start!"
"This proved the power of appropriate Governance, which I believe is a crucial factor for proper oversight," Helen concludes. "In addition, the KPIs were a great support when advocating for our position and enabled us to have a professional approach to possible solutions without creating a blame culture."
In the end, successful clinical trial management comes down to proactive planning, continuous monitoring, and the ability to make data-driven decisions. By staying vigilant, maintaining open lines of communication with all partners, and having robust oversight mechanisms in place, sponsors can navigate the challenges of clinical trials and increase their chances of success. Helen Johansen Blanco's insights provide a roadmap for clinical research professionals to effectively manage their trials, even in the face of significant challenges.
Background
Helen Johansen Blanco is a member of PBC Group's Advisory Board, helping to shape content strategy across the COG Series.