Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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Exciting change abounds in today's clinical trial ecosystem, and that's putting it mildly. The ongoing transformation we witness almost daily includes rapid technological advancements; increasing demand for innovative patient-centric solutions; new and complex regulatory requirements; and the need for innovative operating models that better answer the seismic shifts brought on by COVID-19.
The implications?
Every facet of a clinical trial must be prudently and frequently reassessed in order to ensure meaningful innovation and optimal success in this remarkably dynamic clinical trial landscape. And the most critical aspect of all—not surprisingly—is patient recruitment and retention, a perennial challenge that has become even more vexing in the aftermath of a sweeping global pandemic.
So…what is the best solution for optimizing patient recruitment and retention in this new era of clinical trials?
The answer is fairly simple: employing an insight-driven design and delivery strategy that provides patients and caregivers a more positive research experience.
The first step in more effectively attracting potential patients to participate and stay in clinical trials is to enhance our understanding of who they are as individuals, particularly what drives their decision-making as it pertains to engaging in research. This requires robust and granular analytics, utilizing similar insight-gathering methodologies and practices seen in consumer marketing.
Simply put, we need to know our patients and caregivers better—much better. And we need have genuine empathy in terms of the burden that our trials potentially pose on their lifestyles. Having empathy for patients is not only the right thing to do—it has become a pivotal driver in ensuring success in the design and delivery of today’s clinical trials.
An evidence-based, patient-first approach to design and delivery results in a more positive patient research experience that enhances recruitment and retention. It also helps ensure a more flexible, patient-centric clinical trial. To that end, having richer analytics in place during the design phase empowers patients, caregivers, and researchers alike. Patients—at last—are given a voice in protocol design. At the same time, these deeper insights around trial burden provide sponsors a unique opportunity to improve their design by identifying specific ways of reducing patient burden—well before a trials begins.
Patient burden is one of the most pivotal factors in determining whether a patient participates and remains in a clinical trial throughout the research journey.
At IQVIA, we work with clients to perform a Data Informed Protocol Assessment, or DIPA, on their draft protocols, to provide evidence-based insights and highlight areas for optimization that might impact their trial’s execution. Assessment of patient burden is part of a full DIPA, where we apply data to understand how potential participants may perceive what will be expected of them in the trial. The DIPA includes a range of robust analytics that assess, highlight, and quantify specific areas of burden within a protocol design.
One example of a DIPA patient burden analytic uses real-world data to understand how potential patients may view the trial procedures based on their current experiences and usual care for their disease, and how that compares to the trial requirements. From claims data or medical records data, the assessment shows the percentage of patients that will be familiar with the procedure as well as how frequently they generally experience it. While clinical trials may need to perform some of these procedures more frequently than in real world care, the tool quantifies and highlights in a graphical, meaningful way just how much more burden the trial is requiring on these patients.
By providing these insights, the DIPA empowers sponsors to make evidence-based decisions about how and where to adjust their trial protocols to reduce patient burden and create a more positive research experience.
The DIPA also provides industry benchmarks powered by an extensive database that enables sponsors to compare the burden score of their draft protocol with other relevant trial designs. This has proven to be extremely helpful in ensuring sponsors make judicious, insight-driven enhancements to reduce patient burden in their trials.
DIPA in action: optimizing a Phase 2 study through targeted reduction of burden
A recent case study involved a Phase 2 migraine study that demonstrates how the DIPA was successfully leveraged by a sponsor to reduce patient burden and optimize recruitment and retention.
The DIPA identified 3 key aspects of this Phase 2 trial design that posed a significantly higher level of burden for participants:
Empowered by these insights, the sponsor was able to reduce or eliminate these areas of burden while still maintaining scientifical rigor.
The nuanced insights provided by the DIPA provide a wonderful opportunity to design and deliver clinical trials that maximize the inclusion of different races and ethnicities. But like anything else, success requires maximum focus. As powerful as they are, having these insights is just the beginning. Knowing exactly where—and how—to harness these insights in a clinical trial is as critical as the analytics themselves.
That’s why we at IQVIA focus on applying actionable insights towards 5 critical components within the trial journey that have historically been shown to represent barriers to inclusion. The guidelines listed below serve as a blueprint to break down these specific barriers:
The clinical trial ecosystem has never been more dynamic and exciting, bringing new opportunities and challenges to sponsors, patients, and caregivers alike. But amidst the increasing complexity and change to come in the years ahead, one thing is certain:
The more we listen to patients, the better the design, data, and delivery of our clinical trials.
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Katie Shaw Senior Director Patient Recruitment Strategy at IQVIA |
Denise Messer Director Design Analytics with the IQVIA Applied Data Science Center at IQVIA |
Shana Hull Director Patient Recruitment Strategy at IQVIA |
Sharon Hughes Senior Therapeutic Strategy Director Infectious Disease and Vaccines at IQVIA |
To hear the entire webinar on demand, click here to learn more about Insight-Driven Trial Strategies That Take Patient Centricity to New Heights.
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