Dual Approaches, Added Challenges: Complexities of Combination Therapy Trials in IBD Part 4
By Kremena Stoyanova
Senior Director, Medical Monitoring & Consulting
Overcoming Obstacles in Combination Therapy Research
This is the final part of a series on combination therapies in the treatment of inflammatory bowel disease (IBD). You can read the previous entries in the series at the links below:
In this post, we’ll discuss strategies for addressing common challenges in IBD combination therapy research.
Optimizing study design and patient enrollment criteria
Addressing the potential safety concerns outlined in Part 3 starts with strategic study design informed by the available literature, therapeutic expertise, and trial experience. Protocols will need to include a comprehensive list of entry criteria, taking into account available knowledge about the pharmacodynamic, pharmacokinetic, and safety profiles of the tested therapies, to safeguard patient safety and avoid the incidence of preventable safety events.
Strategies to minimize the risks while optimizing benefits will include different approaches to the timing of combination therapy (for example, simultaneous or sequential administration) and modification in dosing and/or treatment schedule as the trial progresses. Adaptive design trials may be especially useful for advancing combination therapy research. These trials will use clinical, endoscopic, and biomarker study data for decision-making at certain key points during the study.
Leveraging site relationships
As sites will be important partners in enrolling and retaining eligible patients for these studies, it will be critical to bring site teams into the discussion early to understand potential roadblocks. Due to the competitive landscape for IBD, sites also may need additional motivation and support to manage the complexities of combination therapy trials.
For instance, the strict monitoring of safety events occurring during the trials will involve comprehensive safety data collection and analysis, which will greatly depend on the timely and orderly production and receipt of these data. In addition to well-designed clinical and safety databases tailored to the objectives of each particular study, strict guidance on the scope of safety events to be reported by the investigational sites will be key for comprehensive safety monitoring and analysis.
PSI works with more than 4,000 experienced IBD sites around the world and understands their needs and challenges. We created dedicated site support teams that work hand-in-hand with our CRAs to provide additional tailored expertise and assistance to each site, ensuring that the needs of individual investigators and site teams are met. This includes helping sites qualify their endoscopy equipment, optimizing enrollment strategies, and providing visual tools to help sites understand where their patient flow will come from.
Understanding the patient journey
As outlined in our white paper Putting the Focus Back on Site Relationships in Clinical Trials, defining the patient journey by evaluating study procedures from the patient’s perspective is an important first step to help minimize patient burden and impact on sites. This will be especially important for trials of combination therapies.
PSI provides site training and materials to empower sites to develop meaningful and valuable relationships with patients, facilitating these conversations. We also have experience managing robust communication strategies, including social media, study-specific websites, and digital materials written in plain language, that may also be useful to address patient concerns around safety, long-term follow-up, and other challenges.
Conclusion
While IBD combination therapy research is still in its beginning stages, it holds significant potential to address a long-standing unmet need and overcome the current therapeutic ceiling for this disease. At PSI, we focus on pivotal Phase 2 and 3 GI studies, specializing in IBD, so we can ensure sponsors of these complex studies the quickest path to enrollment with the highest quality.
With a unique approach to site support, including on- and off-site support for busy GI sites, our GI trials consistently achieve enrollment rates up to 22% higher than the industry average, and 93% of our studies meet or beat projected enrollment timelines.
To learn more about how PSI can support your upcoming study, contact us today.
Dual Approaches, Added Challenges: Complexities of Combination Therapy Trials in IBD Part 4
By Kremena Stoyanova
Senior Director, Medical Monitoring & Consulting
Overcoming Obstacles in Combination Therapy Research
This is the final part of a series on combination therapies in the treatment of inflammatory bowel disease (IBD). You can read the previous entries in the series at the links below:
In this post, we’ll discuss strategies for addressing common challenges in IBD combination therapy research.
Optimizing study design and patient enrollment criteria
Addressing the potential safety concerns outlined in Part 3 starts with strategic study design informed by the available literature, therapeutic expertise, and trial experience. Protocols will need to include a comprehensive list of entry criteria, taking into account available knowledge about the pharmacodynamic, pharmacokinetic, and safety profiles of the tested therapies, to safeguard patient safety and avoid the incidence of preventable safety events.
Strategies to minimize the risks while optimizing benefits will include different approaches to the timing of combination therapy (for example, simultaneous or sequential administration) and modification in dosing and/or treatment schedule as the trial progresses. Adaptive design trials may be especially useful for advancing combination therapy research. These trials will use clinical, endoscopic, and biomarker study data for decision-making at certain key points during the study.
Leveraging site relationships
As sites will be important partners in enrolling and retaining eligible patients for these studies, it will be critical to bring site teams into the discussion early to understand potential roadblocks. Due to the competitive landscape for IBD, sites also may need additional motivation and support to manage the complexities of combination therapy trials.
For instance, the strict monitoring of safety events occurring during the trials will involve comprehensive safety data collection and analysis, which will greatly depend on the timely and orderly production and receipt of these data. In addition to well-designed clinical and safety databases tailored to the objectives of each particular study, strict guidance on the scope of safety events to be reported by the investigational sites will be key for comprehensive safety monitoring and analysis.
PSI works with more than 4,000 experienced IBD sites around the world and understands their needs and challenges. We created dedicated site support teams that work hand-in-hand with our CRAs to provide additional tailored expertise and assistance to each site, ensuring that the needs of individual investigators and site teams are met. This includes helping sites qualify their endoscopy equipment, optimizing enrollment strategies, and providing visual tools to help sites understand where their patient flow will come from.
Understanding the patient journey
As outlined in our white paper Putting the Focus Back on Site Relationships in Clinical Trials, defining the patient journey by evaluating study procedures from the patient’s perspective is an important first step to help minimize patient burden and impact on sites. This will be especially important for trials of combination therapies.
PSI provides site training and materials to empower sites to develop meaningful and valuable relationships with patients, facilitating these conversations. We also have experience managing robust communication strategies, including social media, study-specific websites, and digital materials written in plain language, that may also be useful to address patient concerns around safety, long-term follow-up, and other challenges.
Conclusion
While IBD combination therapy research is still in its beginning stages, it holds significant potential to address a long-standing unmet need and overcome the current therapeutic ceiling for this disease. At PSI, we focus on pivotal Phase 2 and 3 GI studies, specializing in IBD, so we can ensure sponsors of these complex studies the quickest path to enrollment with the highest quality.
With a unique approach to site support, including on- and off-site support for busy GI sites, our GI trials consistently achieve enrollment rates up to 22% higher than the industry average, and 93% of our studies meet or beat projected enrollment timelines.
To learn more about how PSI can support your upcoming study, contact us today.
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