A data-driven approach to support your needs throughout the clinical trial lifecycle and beyond
Finding comprehensive, high-quality Real World Data (RWD) to support your drug development activities can be challenging.
Without this vital data, you run the risk of failed recruitment goals, potential changes in efficacy, safety and adverse events in a broadened population, regulatory body implications, delayed approval, and costly phase IV studies.
What if you could leverage robust, insightful and actionable RWD, including medical claims, electronic health record (EHR) data, patient demographics and social determinants of health, to improve and enhance sales targeting, feasibility, site selection, diversification strategies and more?
This would allow you to make more educated and tactical decisions across the drug development life cycle, ensuring greater success for your business goals.
Citeline's RWD Solutions are here to support you! Read on to learn more.
As clinical trial complexity and competition for patients continues to increase, the need to leverage comprehensive, global RWD grows more imperative.
RWD can be utilized in a number of applications to inform, support and enhance various drug development activities. Let's explore some key use cases below.
Diversity & Inclusion
Diversity & Inclusion remains a key focus and priority for the industry as pharmaceutical companies and CROs work to ensure underserved populations are well-represented in clinical trials. Identifying specific patient cohorts by age race and gender, and understanding their distribution at the investigator and site level is critical to ensuring the successful recruitment of relevant patients in your studies. The demographic data available within RWD Solutions allows you to understand diversity by:
- Patient to identify and engage specific patient populations meeting the trial’s inclusion/exclusion criteria and diversification goals, increasing recruitment success
- Provider to diversify the racial composition of your investigators and reach potential patients that may otherwise be excluded from trials
- Site to prioritize site selection by uncovering diversity opportunities institution by institution
Further to this, you can enrich your diversification activities by using social determinants of health, which allow you to better understand unforeseen risks that may impact the successful recruitment of underserved populations. By knowing these risks in advance, you can proactively establish support services and programs to circumvent roadblocks and successfully enroll and retain targeted patients in specific communities or cohorts.
Click on the image below to review an example of how RWD Solutions supported a large pharmaceutical company that was looking to further diversify its NASH trial.
Study Feasibility & Site Selection
RWD enables you to take a patient-centric approach to feasibility and site selection, increasing the likelihood of successful recruitment for your trial. With RWD Solutions, you can:
- Analyze the disease landscape to understand accessible patient cohorts meeting the inclusion/exclusion criteria of the trial protocol
- Identify and prioritize high volume sites with clinically and demographically relevant patients
Click on the following image to learn how RWD Solutions supported a large pharmaceutical company with reprioritizing its site list based on patient volume.
With about 80% of clinical trials experiencing delays due to recruitment challenges, you may find yourself in a position prompting you to re-evaluate your clinical trial sites. The medical claims data within RWD Solutions allows you to:
- Analyze existing sites to identify high volume opportunities for reprioritization
- Identify novel sites you haven't previously engaged with to unmask additional pools of relevant, untapped patients
These site-level assessments can shed new light on which sites are best positioned to recruit patients into the study and can help to refocus efforts on those sites with the greatest likelihood of enrolling patients.
RWD applicability extends far beyond clinical trial activities and can support a wide array of commercial activities, including:
- The analysis of referral patterns to uncover health system affiliated HCPs
- The identification and validation of commercial targets
- The use of predictive analytics to analyze the opportunity now and in the future
It is imperative that sales and marketing reach not just any customer, but penetrate to key decision makers that will enable a deeper and more significant market impact. Leverage RWD Solutions to ensure your commercial efforts align with the right targets.
Synthetic Control Arms
In some disease models, Standards of Care (SOC) used within the control arm of clinical trials can become outdated and don’t always represent how patients are currently being treated. As a result, the control arm becomes less of a relevant or valid comparator for patients receiving the target therapy.
Instead, leverage a synthetic control arm powered by RWD, which monitors the data-verse of patient care for a specific disease and its treatment protocol, ensuring the most relevant data and outcomes are being measured against the treatment arm of your clinical trial.
Additionally, use of a synthetic control arm can reduce or eliminate the need for patient recruitment into a traditional control arm and allows you to use your time and resources more efficiently.
If you are interested in learning more about these use cases, or if you have a need for RWD to support another use case, please complete the form at the end of this eBook and our team of experts will be in touch to discuss further.