Clinical Trials Transformation Initiative (CTTI) released recommendations and tools related to using real-world data (RWD) to inform selecting eligibility criteria and recruitment of subjects for clinical trials. RWD are data related to patient health and health care delivery. Data are commonly collected from Electronic Heath Records (EHR) or other sources related to patient health, such as insurance claims. RWD has been available, but there has been a lack of research or consensus on how to use the information beneficially for clinical trials. These recommendations were developed through research and collaboration with stakeholders, including patients and caregivers, to provide the first steps for how sponsors may best use the RWD to plan for clinical trial eligibility requirements and recruitment.
The principles for using RWD
Using RWD to plan feasible eligibility criteria
Recommendations for using RWD to support recruitment
Recommendations for enhancing RWD capabilities for the research enterprise
The five actionable tools are:
Using RWD as a standard process in study planning and recruitment
Evaluating if RWD is suitable for planning eligibility criteria and supporting recruitment
Effective RWD supported discussions of eligibility criteria
Evaluating feasibility of RWD supported recruitment
Planning RWD supported recruitment strategies
RWD should be sought early in the product lifecycle, during the study design. This will reduce the time needed for study start up. Traditionally, eligibility criteria were based upon traditions and assumptions made from previous studies. RWD can test these assumptions and perhaps remove non-essential exclusion criteria, supporting realistic criteria. If the exclusion criteria are found to be essential, RWD can inform on the risks to recruitment so that mitigation plans can be made proactively, early in development.
Additionally, it is important to understand the needs of the patients and the sites to support recruitment. RWD can determine what level of personalized interaction may be necessary for patients to feel comfortable related to their privacy and expectations, and therefore inform more efficient and effective recruitment strategies. Although RWD may improve study design, streamline eligibility criteria, and increase recruitment, they do not provide all the data required. There will still be a manual process for recruitment, and data alone do not provide a complete picture. Involving patients and sites in study planning improves study quality.
One challenge to collecting and using RWD is data privacy. In the modern era of increasing regulations protecting data subjects such as General Data Protection Regulation (GDPR), the use of RWD may need to be re-evaluated for global use. Increased use of a patient-centric approach and RWD will continue to grow in the future, as will the eventual globalization of this type of data.
- The Clinical Pathways Team
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