Recruitment Archives - Page 5 of 6

CTTI Article in Contemporary Clinical Trials Outlines Framework for Successful Trial Recruitment

Posted on February 8, 2018March 10, 2025 by Lorri Bingham

A CTTI article outlining a framework for successful clinical trial recruitment planning was recently published in Contemporary Clinical Trials.

While patient recruitment is widely recognized as a key determinant of success for clinical trials, a substantial number of trials still fail to reach their recruitment goals. To address this issue, CTTI convened a project team to examine the challenges and develop actionable, evidence-based recommendations for improving recruitment planning.

These recommendations propose an upstream approach to recruitment planning, focusing on factors that affect recruitment earlier in clinical trial development. The recommendations focus on three essential areas in particular:

Trial design and protocol development: Identifying all stakeholders, ensuring the relevance of the scientific question, limiting complexity, having realistic eligibility criteria, and optimizing data collection.
Trial feasibility and site selection: Conducting evidence-based feasibility analysis, having realistic metrics and milestones, developing an adequate budget and resources, ensuring appropriate site selection, and engaging in suitable performance monitoring.
Communication planning: Identifying where participants seek treatment, developing and testing tailored messages, developing creative material and selecting appropriate delivery channels, having a realistic budget, monitoring and evaluating process and performance, and embedding recruitment intervention studies and sharing results.

CTTI also developed resources to help facilitate adoption of the recommendations, including methods for identifying stakeholders and considerations for patient-reported outcomes. Together, the recommendations and tools are designed to guide efforts in clinical trial recruitment planning and identify areas for continual improvement.

Four Key Areas Where CTTI Has Transformed Clinical Trials

Posted on January 8, 2018March 10, 2025 by Lorri Bingham

This year, CTTI marks its 10th year of working with a variety of stakeholders to positively change clinical trials, making them more streamlined, efficient, and patient-focused. To commemorate this milestone, we will #CelebrateCTTI throughout the month of January. Join us for the celebration—visit this blog, follow us on Twitter, and register to attend our 10 Year Anniversary Symposium on Tues., Feb. 6.

Since its inception in 2007, CTTI has made transformational shifts in the design and conduct of clinical research. Let’s take a look at the evolution of clinical trials in four key areas, among many, in which CTTI has played a critical role in moving the industry toward more efficient, high-quality, and patient-centric trials:

Trial Quality

Regulators have long acknowledged a need to change how the industry approaches clinical trial quality in order to focus on reducing errors that undermine data integrity and patient safety. Drawing on the expertise of key stakeholders, CTTI issued recommendations on effective and efficient trial monitoring in 2012. The following year, FDA issued final guidance on a risk-based approach to monitoring, reflecting principles from CTTI’s work. CTTI also developed the concept of Quality by Design, taking the focus from a reactive approach using audits to a proactive approach that builds quality into clinical trials at the outset. CTTI released its Quality by Design recommendations and toolkit in 2015, and its work in this area has been cited in FDA guidance and incorporated into GCP guidelines.

Patient Engagement

CTTI has been a pioneer in patient engagement, involving patient representatives in its organizational leadership and throughout its project teams. Spurred by the FDA’s Safety and Innovation Act of 2012, CTTI initiated the Patient Groups & Clinical Trials Project to establish best practices for engaging patients in clinical research. In 2014, CTTI released landmark recommendations that are currently used by multiple stakeholders to facilitate productive relationships with patient groups around clinical trials. In 2017, CTTI and FDA announced a partnership on a new initiative, the Patient Engagement Collaborative, to improve patient engagement across the FDA.

Central IRB

Although U.S. regulators are enthusiastic about the use of a central IRB to promote more efficient multi-site clinical trials, enterprise-wide implementation has lagged. CTTI initiated the Central IRB Project in 2010, creating recommendations and resources to help organizations identify and address barriers to the adoption of a central IRB. The NIH issued a draft policy in 2014 referencing CTTI’s recommendations and a final policy in 2016 requiring all NIH-funded multi-site clinical trials to use a central IRB effective in 2018.

Real-World Evidence

Since its inception, CTTI has recognized that “real-world evidence” from electronic health records, mobile devices, and other sources can provide unique insights into important clinical questions and could improve the efficiency of clinical trials. The FDA Amendments Act of 2007, which mandated FDA to develop a system to link safety data from multiple sources, paved the way for the use of connected datasets in clinical trials. After partnering with the FDA and Harvard Pilgrim Health Care Institute to assess the feasibility of using the Sentinel database for clinical research, CTTI supported the first trial using Sentinel. CTTI also launched a program in 2016 to support the use of mobile technology in clinical trials, issued recommendations in 2017 on how to use registries as reusable platforms for trials, and announced a Real-World Evidence Project in 2017.

CTTI Launches New Project to Accelerate Use of Real-World Data in Clinical Trials

Posted on November 15, 2017March 10, 2025 by Lorri Bingham

New approaches to clinical research that harness diverse sources of “real-world data” (RWD) could accelerate the pace of clinical trials, reduce costs, and provide new insights into patient experiences. Keeping at the forefront of this movement, CTTI today announced a new Real-World Evidence Project that is designed to foster greater awareness of these data sources and explore effective ways to leverage them for clinical trials.

Unlike conventional clinical trial data gathered using specialized, costly, and complex systems, RWD is captured from existing sources such as electronic health records (EHRs), billing and insurance claims databases, disease registries, patient generated data, and even mobile devices. When combined and analyzed, these data can yield “real-world evidence” (RWE) that may provide a more accurate and complete picture of patient outcomes and experiences.

However, despite this potential, there have been relatively few attempts to incorporate RWE into trials intended to support regulatory decision making for new medical products and labeling indications—in part because stakeholders have not yet agreed on valid and effective approaches.

CTTI’s RWE work is helping to meet these challenges by:

Describing how these sources of data can be leveraged to plan and conduct trials;
Identifying and addressing barriers to such use
Identifying when RWD/RWE usage may be impractical or unwise; and
Developing practical approaches to embedding RWE in clinical research.

Ultimately, broad adoption of RWE for regulatory trials may benefit patients and other stakeholders by efficiently creating high-quality, reliable evidence about the safety and effectiveness of medical products.

Recording Now Available: Webinar on Improving Clinical Trial Recruitment

Posted on September 7, 2016March 10, 2025 by Lorri Bingham

On May 19, 2016, CTTI hosted a webinar on moving recruitment planning upstream to reduce barriers to clinical trial participation. This webinar was the official unveiling of CTTI’s new recommendations and tools resulting from the Recruitment Project. We are now pleased to share the recording from this webinar, in which you can learn more about:

A holistic approach that integrates strategic recruitment planning throughout the entire clinical trial process, beginning with study design and development
Ways to identify and engage all relevant stakeholders throughout recruitment planning to prevent downstream recruitment challenges
Recommendations for trial feasibility, site selection, and developing strategic recruitment communication plans
New tools available to aid in strategic recruitment planning

The slides and responses from the webinar’s Q&A session are also available for download.

We encourage you to share these resources with your colleagues in the clinical trials enterprise.

To view recordings of other CTTI webinars, CLICK HERE.

Earlier Strategic Planning Key to Clinical Trial Recruitment, According to New CTTI Recommendations

Posted on May 19, 2016March 10, 2025 by Lorri Bingham

CTTI has released new recommendations and tools for enhancing the efficiency of clinical trial recruitment. Patient recruitment is a leading challenge in the efficient completion of clinical trials, which can result in wasted resources and delays in bringing new therapies to market. The foundational principle for this new approach is that recruitment planning should be started earlier in the clinical trial development process and continue throughout the implementation.

DOWNLOAD THE RECOMMENDATIONS

“The Recruitment Project recommendations are the result of an in-depth study evaluating why too often clinical trial recruitment efforts fail,” said Jonca Bull, MD, the FDA’s Assistant Commissioner for Minority Health. Bull served as a team lead for the Recruitment Project. “These recommendations have the potential to catalyze greater efficiencies in diverse patient recruitment–women, minorities, and older adults–by focusing on the earliest stages in protocol development.”

The recommendations and tools were developed with input from a diverse team of stakeholders, including clinical researchers, patient advocates, and representatives from academia, industry, and the FDA. “What we found was that, to truly make a difference, we need a comprehensive solution that covers all areas of clinical research, from making sure the study is asking the right questions–questions that matter to patients and providers–to shaping study design and feasibility, to budget and implementation,” said Kelly McKee, a project team member from Eli Lilly and Company. Among the released tools, a new framework outlines considerations for strategic recruitment planning throughout all stages of a clinical trial.

According to the recommendations, recruitment planning should also be more inclusive of all relevant stakeholders. “Too often important feedback from patients, study coordinators, and health care providers is not obtained when their insights can make or break a trial and prevent avoidable amendments,” said Bray Patrick-Lake, Director of Patient Engagement for the Duke Clinical and Translational Science Award. “CTTI’s evidence-based recommendations and toolkits provide practical guidance for successful clinical trial recruitment planning that will help ensure stakeholders are appropriately engaged and the right questions are asked during study design, feasibility, and recruitment planning activities.”

A thoughtful approach to recruitment planning before study activation is expected to alleviate downstream recruitment challenges and ensure trial viability. The work builds on CTTI’s previous advancements in the areas of engaging patient groups in clinical trials and a quality by design approach to improving clinical trials.

Wall Street Journal Tips Hat to CTTI’s Recruitment Project

Posted on April 12, 2016March 10, 2025 by Lorri Bingham

Yesterday, the Wall Street Journal published an article on clinical trial recruitment, zeroing in on the critical need for improved patient recruitment rates. This article features CTTI’s Recruitment Project, which will be releasing official recommendations in a free, public webinar on May 19, 2016 from 12:00 – 1:00 PM EST. To receive details about this upcoming webinar, sign up for CTTI’s monthly e-newsletter here.

We are pleased to see the exploration of this important topic in mainstream international media and are proud to be a trusted voice in this space.

Recently Released: Expert Meeting Summary on Recruitment

Posted on January 26, 2016March 10, 2025 by Lorri Bingham

On November 9 – 10, 2015, CTTI’s Recruitment Project Team hosted a multi-stakeholder, expert meeting to address the following objectives:

Present findings from the CTTI Recruitment Project’s evidence-gathering activities
Obtain stakeholder perspectives and critical feedback on draft considerations for more effective recruitment planning
Develop consensus across multiple stakeholder perspectives on the mechanisms for moving recruitment planning upstream and achieving culture change
Identify implementation barriers to achieving change
Develop consensus across multiple stakeholder perspectives on the mechanisms for overcoming barriers to achieving change

Maximizing recruitment efforts depends on the design and feasibility of the clinical trial protocol and site selection, as well as appropriate communication planning. Attendees discussed how to improve clinical trial recruitment efforts by incorporating Quality by Design (QbD) concepts into recruitment planning strategies, identifying and engaging important stakeholders, viewing recruitment through a patient-centric lens, and crafting and positioning the right messaging to encourage the public to inquire about recruitment opportunities. Experts presented and discussed current patient and public perceptions of clinical research and how this impacts trial recruitment. To improve recruitment overall, participants acknowledged that trust and better rapport among research scientists/medical professionals and patients/the public need to be fostered. Additionally, recruitment planning cannot rely on a one-size-fits-all approach; recruitment efforts must be fit for purpose and tailored to individual trials.

New Publication: CTTI Presents Stakeholder Survey Results on Barriers and Solutions to Clinical Trial Recruitment

Posted on September 5, 2015March 10, 2025 by Lorri Bingham

This week, Applied Clinical Trials published Barriers to Clinical Trial Recruitment and Possible Solutions: A Stakeholder Survey. This publication is the result of the CTTI Recruitment Project Team’s efforts to gain a deeper understanding of stakeholders’ perceived barriers to recruitment across the clinical research enterprise. Several stakeholder groups, including clinical trial sponsors (industry, federal, and academic), research sites (investigators, coordinators, and executive-level staff), and patient advocacy organizations, were polled to gather information on approaches that will improve patient recruitment and enable trials to meet recruitment goals. The significant barrier most often cited by respondents was that of finding or identifying patients who meet eligibility criteria. A solution to this barrier that was proposed by a respondent was to broaden the eligibility requirements to enroll individuals more representative of the actual population. To improve recruitment efforts, respondents felt that medical record and hospital-based registry or database review were effective and often successfully employed. Additionally, building relationships and establishing referral programs with trusted clinicians were considered crucial to enhance recruitment. Overall, the majority of respondents had a positive outlook on the potential to increase recruitment rates over the next decade.

“The positive outlook on increasing clinical trial recruitment over the next 5 to 10 years among respondents is encouraging of the potential for progress to be made. It is apparent that a comprehensive recruitment strategy, rather than a single tool or solution, will be required to address the range of significant recruitment barriers identified.” – E. Mahon, et al.

To read the publication, click here.