Recruitment
CTTI Releases 2017 Annual Report: One Decade of Impact. One Vision Ahead.
CTTI’s 2017 Annual Report, released today, celebrates a decade of CTTI impact and highlights our activities and accomplishments over the past year. The report includes reflections from past and present CTTI leaders, case studies on the use of CTTI recommendations and resources, and a glimpse into what lies ahead for CTTI and the clinical trials enterprise.
Since its founding in 2007, CTTI has completed more than 25 projects with the aim of increasing the quality and efficiency of clinical trials. The resulting recommendations were downloaded more than 26,000 times over the past year.
CTTI issued five new sets of recommendations in 2017, many of which draw on recent advances in technology and data sciences to bring about improvements for clinical trials. Read the report to learn more about our latest recommendations and resources, which offer:
- Practical guidance for using mobile technology to develop viable novel endpoints for clinical trials.
- Best practices for assessing and designing registries for use in clinical trials so that the data can meet expectations for FDA review of new products.
- Actions that can be taken to strengthen the investigator site community and create an environment that sustains long-term investigator engagement.
- Guidance on planning for and making decisions about pregnancy testing in potential trial participants.
- Suggested ways to address the unique challenges of conducting pediatric antibacterial trials.
As described in the report, these recommendations and resources are being implemented by organizations across the clinical trial spectrum, including IQVIA, monARC Bionetworks, and the Pulmonary Fibrosis Foundation.
As we reflect on the past year—and the past decade—we are grateful for the engagement and commitment of our members, who ensure that we continue to address the latest trends, top barriers, and leading opportunities in clinical research.
CTTI Article in Contemporary Clinical Trials Outlines Framework for Successful Trial Recruitment
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.
Recording Now Available: Webinar on Improving Clinical Trial Recruitment
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
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
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
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
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.