CTTI introduced new recommendations, resources and case studies for using electronic medical records (EHRs) and claims data to plan trial eligibility criteria and recruit participants to trials. CTTI seeks to fill an important gap as many touts the importance of Real World Data (RWD) but few resources have emerged to lead sponsors and stakeholders in clinical trials through the process of formally integrating RWD into their trial designs.

TrialSite News breaks this news down for our rapidly growing and highly diversified audience via the question and answer format. Our focus includes real-world evidence-based studies as the development of new therapies will increasingly incorporate real-world data elements.

Who is CTTI?

CTTI stands for the Clinical Trials Transformation Initiative. A public-private partnership, co-founded by Duke and the U.S. Food and Drug Administration (FDA), it now comprises 80 member organizations—representing academia, clinical investigators, government and regulatory agencies, industry, IRBs, patient advocacy groups, and other stakeholders.

What do they do?

CTTI seeks to work with the expertise of its internal members to unite the best and brightest with diverse viewpoints to improve clinical trials. Their multi-stakeholder project teams use various research methods to gain a complete and objective understanding of a particular issue. CTTI then applies the developed evidence to develop and drive the adoption of recommendations and tools that change the way stakeholders think about, design and conduct clinical trials.

What is Real-World Data (RWD) or Real World Evidence (RWE) trials?

According to the FDA RWE in medicine means evidence obtained from RWD which are observational data obtained outside the context of randomized controlled trials (RCTs) and generated during routine medical practice. RWD is frequently used to assess patient outcomes as well as ensure that patients receive the correct treatment. RWE is generated by analyzing data that is stored in electronic health records (EHR), medical claims or billing activities databases, registries, patient-generated data, mobile devices, etc. This RWE may be derived from retrospective or prospective observational studies and observational registries. The FDA is required to expand the role of RWE by the 21st Century Cures Act

What are Initial Trends in RWD?

The growing availability of real-world data (RDW) creates opportunities not only for innovation in evidence generation but also for improving the efficiency and potential success rates or more traditional random controlled trials. CTTI notes that already to varying degrees clinical trials sponsors already use RWD to make data-driven decisions about trial feasibility, based on an assessment of planned eligibility criteria.

Increasingly, RWD is used to support targeted, timely, and personalized outreach that may improve the efficiency and effectiveness of the recruitment process.

And increasingly, RWD is being used to support targeted, timely, and personalized outreach that may improve the efficiency and effectiveness of the recruitment process.

What are the CTTI recommendations, resources and case studies useful for?

The CTTI recommendations help clinical trials sponsors, sites and stakeholders 1) determine whether RWD is a fit for purpose with respect to study planning and recruitment; 2) optimize the use of RWD for study planning and recruitment by engaging cross-functional teams and building out organizational systems and processes and 3) understand patient and site needs to develop successfully and patient-centric approaches to RWD-supported recruitment.

How did they Apply Their Process to Real World Evidence (RWE) Trials?

CTTI conducted research with its stakeholders across the clinical trials ecosystem to develop recommendations and resources—including three case studies that elucidated the process of integrating RWD into trial design.

The CTTI RWD Other efforts related to RWE trials produced a Recommendations document that includes the following:

·Co-leading a proof-of-concept study assessing the feasibility of using FDA Sentinel System infrastructure to conduct randomized clinical trials.

·Recommendations on how to assess and design registries so that data can meet expectations for the FDA review of new products

·Recommendations and robust toolkit to help drive a Quality by Design (QbD) approach, which engages a broad range of shareholders and focuses on the errors that matter to decision making.

Who Funded this Initiative?

The funding for this CTTI RWD initiative was made possible by an FDA grant (R18FD005292) and a cooperative work agreement (U19FD003800).

Where can the CTTI Recommendations, Resources, and Case Studies be Found?

On CTTI’s website

Who Can I Contact at CTTI for more Information?

The CTTI’s Executive Director is Pamela Tenants

Source: CTTI

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