Recruitment Archives - Page 4 of 6

Informed Consent

Topics Included: Recruitment, Safety

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The informed consent process can often be burdensome and lacks giving prospective trial participants the information they need to aid in their decision to participate.

Use CTTI’s recommendations and resources – an informed consent discussion tool and tiered informed consent document – to optimize your informed consent process and provide participants with clear, accurate information about trial specifics, risks, and benefits.

What is the issue?

In accordance with medical ethics regarding research on human subjects and federal regulatory requirements, it is necessary to obtain informed consent (IC) from prospective clinical trial participants. Required elements of IC in health research governed by U.S. Federal Regulations, including FDA regulations and the Common Rule, are clearly described, yet the current IC process is often not meeting the needs of research participants. Informed consent documents (ICDs) are lengthy and may be difficult for patients to comprehend. Institutionally-required legal language is often inserted into ICDs, creating confusion about whether the ICD’s purpose is to clearly inform the patient or to serve institutional needs. Various groups have taken measures to address these concerns, but deficiencies with the process still exist. Issues surrounding re-consent of research participants, as well as when consent is required in a learning system of health care, are related issues but are outside the scope of this project.

What CTTI project has been initiated to address the issue?

What are the objectives of CTTI's work on informed consent?

Identify previous and current efforts to improve ICDs and the IC process, including alternatives to the traditional paper ICD
Describe barriers and propose potential remedies to concisely communicating the required elements of IC
Propose a more effective process, including IC documentation, for ensuring research participants’ understanding of critical IC elements, taking into account variability among research settings and participants

What is the anticipated impact of CTTI's work on informed consent?

Completion of the CTTI Informed Consent project will lead to a higher quality IC process. Application of the corresponding recommendations may lead to the following improvements:

The IC process may be more interactive, customized, and transparent to meet the needs of individual study participants.
Trial staff can benefit from better training tailored to their needs and learning styles, and patients can benefit from more emotionally responsive trial staff.
The ICD can be restructured to increase readability, enhance trial participant understanding of the study, and provide additional information that is easily accessible.
Electronic consent systems may be considered to facilitate use of the improved ICD and consent participants.

How was evidence gathered to support our findings?

What were the findings from this project?

Evidence from the literature review suggests that IRB-, sponsor-, and site-related operational barriers exist, along with an inadequate understanding of what patients want from the IC process. No single proven tool for measuring the quality of IC or effectiveness of consent interventions was cited in the literature. Limited, available evidence suggests that the current consent process has direct consequences on the ability to conduct clinical trials. The analysis of the literature review was published in May 2016. The published results from the expert interviews supported these literature review findings and expanded on identified barriers.

All interviewees agreed that IC is essential to the protection of research participants; however, most acknowledged that the IC process in the United States has evolved into a rigid and cumbersome process that requires immediate attention and reform. Interviewees expressed consensus on three major themes: a new approach to the ICD, enhancing participant understanding of the clinical research, and modification of IRB review.

Some barriers that result in lengthy, variable, and overly complicated ICDs include the following:

IRB-related:

Lack of accepted readability standards
Local IRB review of ICDs in multisite trials
Varying interpretations of regulations
Inadequate training in plain language practices for IRB staff

Sponsor-related:

Challenging legal language added to ICDs to reduce liability

Staff-related barriers to a successful IC process tend to more commonly result in participant dissatisfaction due to unmet emotional needs or lack of relevant trial information. These barriers include:

Disconnection between expectations and reality of IC discussions
Staff de-emphasizes importance of the information to the participant
Pressure to meet enrollment targets shifts focus away from participants and leads to rushed interactions

To address these barriers, experts explored new approaches to the IC process that focused on enhancing trial participant understanding. The most frequent recommendation for a single actionable change was to reform the ICD required for federally regulated research by making it simpler, shorter, and more understandable. Following this, interviewees proposed multiple strategies to create a more interactive and ongoing IC process to enhance research participant understanding. Some strategies include improving staff training on the conduct of an IC discussion, allowing adequate time and selecting the appropriate setting for the discussion, and providing an opportunity for prospective research participants to speak with other participants as a resource for information. Evaluating participants’ understanding was another topic that experts discussed during the interview. Several interviewees proposed that research participants’ comprehension about the clinical investigation be evaluated. A third consensus issue from the interviews was the need for modification of practices in IRB review of clinical research. Aligned with recommendations from the CTTI Single IRB projects, the most substantive expert recommendation was implementation of a single IRB of record for multisite clinical trials.

Additional Resources

Current Relevant FDA and DHHS Regulations:

FDA Regulations are detailed in 21 CFR, Part 50 (Informed Consent of Human Subjects). 50 Subpart B sections on informed consent of human subjects include:

50.20 - General requirements for informed consent
50.23 - Exception from general requirements
50.24 - Exception from informed consent requirements for emergency research
50.25 - Elements of informed consent
50.27 - Documentation of informed consent

DHHS regulations are detailed in 45 CFR, Part 46 (Protection of Human Research Subjects). 46 Subpart A sections on informed consent include:

46.116 - General requirements for informed consent
46.117 - Documentation of informed consent

NIH Collaboratory:

View the NIH Collaboratory's free resources on informed consent.
View a moderated discussion on the HHS Public Meeting Related to Protection of Human Subjects and Standard of Care Research.

Project Team Members

Role	Name	Affiliation
Project Manager	Annemarie Forrest	Clinical Trials Transformation Initiative
Team Leader	Michele Kennett	University of Missouri
Team Leader	Jennifer Lentz	Eli Lilly
Team Leader	Jane Perlmutter	Individual Patient/Caregiver
Team Member	Julia Gorey	Office for Human Research Protections
Team Member	Sheila Young	GlaxoSmithKline
Team Member	Cheryl Grandinetti	Food and Drug Administration
Team Member	Annick Anderson	CISCRP
Team Member	Fred Bloom	CDC
Team Member	Steve Cummings	University of California, San Francisco
Team Member	Molly Flannery	Food and Drug Administration
Team Member	Zachary Hallinan	CISCRP
Team Member	Karim Calis	Food and Drug Administration
Team Member	Jayvant Heera	Pfizer Inc
Team Member	Kevin Hudziak	Eli Lilly
Team Member	Hallie Kassan	Feinstein Institute for Medical Research
Team Member	Beverly Lorell	King & Spaulding
Team Member	Ross McKinney	Duke University
Team Member	Marsha Melvin	Food and Drug Administration
Team Member	Stephen Mikita	Individual Patient/Caregiver
Team Member	Linda Morgan	Individual Patient/Caregiver
Team Member	Seth Schulman	Pfizer Inc
Team Member	Rose Tiernan	Food and Drug Administration
Team Member	Kaveeta Vasisht	Food and Drug Administration
Team Member	Shelia Young	GlaxoSmithKline

Organization affiliations are listed as active affiliations during the project.

*Indicates former project manager, team leader, or team member.

Resources

Safety

Informed Consent

The informed consent process can often be burdensome and lacks giving prospective trial participants the information they need to aid in their decision to participate.

Recruitment

In order to ensure your trial has adequate recruitment, you have to plan for it. It sounds simple, but a primary reason why clinical trials stop early is because of...

Site Planning | CTTI News

Webinar Now Available: CTTI’s New Recommendations for Using Real-World Data Sources to Enhance Trial Quality and Efficiency

Site Planning | Press Releases

CTTI Releases New Recommendations and Resources for Using Real-World Data to Plan Trial Eligibility Criteria and Recruit Participants

Recruitment | CTTI News

CTTI Unveils New Recommendations for Using Real-World Data Sources to Boost Trial Quality and Efficiency

Recruitment | CTTI News

CTTI to Launch New Work Highlighting the Opportunities for Using Real-World Data to Enhance Trial Quality and Efficiency

CTTI will host a public webinar on Thurs., Oct. 17, to announce new recommendations, resources, and case studies on how to use real-world data (RWD) to evaluate trial eligibility criteria and recruit...

Recruitment | CTTI News

Article Outlines Lessons Learned from First Large Pragmatic Trial Using Sentinel

A new article in Clinical Trials, co-authored by CTTI, outlines lessons learned from the planning phase of the implementation of a randomized controlled trial to improve treatment with oral anticoagulants in patients with Atrial...

Regulatory Submissions + Approvals | CTTI News

CTTI Article Finds that Patients and IRBs are Amenable to Early Enrollment Strategy

Recruitment | CTTI News

Experts Explore Ways to Promote Use of Real-World Evidence in Clinical Trials: Latest CTTI Expert Meeting Summary Now

Recruitment | Publications

Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative

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Stage of Trial

Recruitment

Topics Included: Ensuring Quality, Recruitment

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In order to ensure your trial has adequate recruitment, you have to plan for it. It sounds simple, but a primary reason why clinical trials stop early is because of a failure to enroll enough participants.

Meet your recruitment goals and help ensure the successful completion of your clinical trial by using CTTI’s recommendations for strategic recruitment planning. With this framework, you can explore new approaches to recruitment and learn how to help meet enrollment numbers by conducting evidence-based trial feasibility analyses and selecting the most appropriate sites.

What is the issue?

Recruitment is a critical factor that can determine the success or failure of a clinical trial, and a staggering number of clinical trials continue to fail to meet recruitment goals despite previous efforts. Sub-optimal trial recruitment directly translates into missed opportunities for patients who can benefit from clinical trials, the loss of a chance to advance the science and understanding of disease and find new therapies, as well as wasted time, funds, and other resources. Many explanations have been offered to elucidate the failure to recruit adequate numbers of patients, including poor study design, lack of patient engagement, insufficient staff time, inadequate attention to determine and identify available patients who meet eligibility criteria, and inadequate centralized site support.

While various approaches have been taken to address recruitment challenges, relatively little has been done to bring together the strategies, resource considerations, and/or stakeholder perspectives that are needed to help plan for efficient and effective recruitment. Furthermore, since recruitment activities are often iterative processes during a clinical trial, adopting a systematic framework early in study planning likely can facilitate subsequent actions. Actionable solutions are needed to inform best practices for trial recruitment processes.

What CTTI project has been initiated to address the issue?

What are the objectives of CTTI's work on recruitment?

The project aims to address the barriers to recruitment of patients in clinical trials. This project has two work streams with distinct objectives:

Understanding the barriers and solutions for identifying, engaging, and enrolling patients in trials.
Identifying methods and strategies to move recruitment planning upstream in the study development process in order to reduce the number of recruitment barriers designed into clinical trials.

What is the anticipated impact of CTTI's work on recruitment?

How was evidence gathered to support our findings?

What are the findings from this project?

Barriers identified by survey respondents included the following, in order of significance:

Issues identifying patients who meet eligibility criteria
Insufficient staff time for recruitment
Lengthy and complicated consent forms
Meeting protocol requirements other than recruitment criteria

Medical record and hospital-based registry or database review were methods that survey respondents felt were most effective and most often successfully employed to improve recruitment; however, no single tool or method alone is sufficient to address the range of significant barriers identified.

Potential solutions proposed by the respondents to address recruitment barriers included increasing education, leveraging technology, obtaining patient/community input, improving planning and budgeting efforts, and streamlining aspects of the study. The most frequent recommendation for identifying eligible patients was to engage in effective study planning, including appropriate site selection.

Following the literature review and survey, recommendations were developed that detail strategic approaches to enhance recruitment across all stages of clinical trial planning. The recommendations contain the following broad suggestions for improvement:

Considerations for participant recruitment must begin earlier, if not at the initial outset of trial planning, and take into account the following:
- Scientific relevance
- Eligibility
- Procedural burden
- Design complexity and data collection
An in-depth, evidence-based study level feasibility assessment should be conducted at the time of study question design and protocol development to ensure the target study population exists and can be accessed. The three keys to successful recruitment, with regard to sites, include the following:
- Thoughtful selection of sites
- Setting clear expectations with ongoing performance monitoring
- Mechanisms to provide appropriate feedback
Recruitment can be improved with effective communication to the target stakeholders and decision-makers, including patients, caregivers, investigative site personnel, and healthcare professionals. Four key elements drive a person’s decision to participate in a trial:
- Practical Factors (study burden, risk, etc.)
- Emotional Factors (fear, altruism, trust, personal rewards including access to treatment otherwise unavailable, satisfaction with current therapy, etc.)
- Environmental Factors (family and friend opinions, primary care MD, etc.)
- Logistical and Financial Factors (insurance coverage, out-of-pocket expenses, accessibility to the site, visit schedule and convenience, etc.)

Project Team Members

Role	Name	Affiliation
Project Manager	Annemarie Forrest	Clinical Trials Transformation Initiative
Team Leader	Jonca Bull	Food and Drug Administration
Team Leader	Pat Furlong	Parent Project Muscular Dystrophy
Team Leader	Elizabeth Mahon	Johnson and Johnson Pharmaceutical Research and Development
Team Member	Kathryn Capanna	Food and Drug Administration
Team Member	Elisa Cascade	Quintiles
Team Member	David Ciavarella	CR Bard, Inc.
Team Member	Beth Harper	Consultant
Team Member	Grant Huang	United States Department of Veterans Affairs
Team Member	Adwoa Hughes-Morley	University of Manchester
Team Member	Leslie Kelley	Duke University
Team Member	Barbara LeStage	Individual Patient/Caregiver
Team Member	Holly Massett	National Institutes of Health
Team Member	Kelly McKee	Eli Lilly
Team Member	Margo Michaels	Education Network to Advance Cancer Clinical Trials
Team Member	Ashish Oza	St. Jude Medical
Team Member	Anuja Rastogi	Food and Drug Administration

Organization affiliations are listed as active affiliations during the project.

*Indicates former project manager, team leader, or team member.

Resources

Safety

Informed Consent

The informed consent process can often be burdensome and lacks giving prospective trial participants the information they need to aid in their decision to participate.

Recruitment

In order to ensure your trial has adequate recruitment, you have to plan for it. It sounds simple, but a primary reason why clinical trials stop early is because of...

Site Planning | CTTI News

Webinar Now Available: CTTI’s New Recommendations for Using Real-World Data Sources to Enhance Trial Quality and Efficiency

Site Planning | Press Releases

CTTI Releases New Recommendations and Resources for Using Real-World Data to Plan Trial Eligibility Criteria and Recruit Participants

Recruitment | CTTI News

CTTI Unveils New Recommendations for Using Real-World Data Sources to Boost Trial Quality and Efficiency

Recruitment | CTTI News

CTTI to Launch New Work Highlighting the Opportunities for Using Real-World Data to Enhance Trial Quality and Efficiency

Recruitment | CTTI News

Article Outlines Lessons Learned from First Large Pragmatic Trial Using Sentinel

Regulatory Submissions + Approvals | CTTI News

CTTI Article Finds that Patients and IRBs are Amenable to Early Enrollment Strategy

Recruitment | CTTI News

Experts Explore Ways to Promote Use of Real-World Evidence in Clinical Trials: Latest CTTI Expert Meeting Summary Now

Recruitment | Publications

Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative

Refine Your Selection

Formats

Stage of Trial

Webinar Now Available: CTTI’s New Recommendations for Using Real-World Data Sources to Enhance Trial Quality and Efficiency

Posted on October 28, 2019March 6, 2025 by Lorri Bingham

A recording is now available of the public webinar held on Thurs., Oct. 17, to launch CTTI’s new recommendations for using real-world data (RWD) to plan trial eligibility criteria and recruit participants. The webinar was led by Sudha Raman of Duke University, and Jack Sheehan of Janssen Scientific Affairs.

CTTI conducted research and collaborated with stakeholders across the clinical trials ecosystem to develop these recommendations and resources, including three in-depth case studies that elucidate the process of integrating RWD into trial design. The case studies offer a look into the specific challenges faced by each sponsor, how they used RWD to address those challenges, and what they learned along the way.

This project is one in a growing portfolio of CTTI work focused on improving quality in trials and embracing novel trial designs. Other related CTTI efforts include:

Co-leading a proof-of-concept study to assess the feasibility of using the FDA Sentinel System infrastructure to conduct randomized clinical trials.
Recommendations on how to assess and design registries so that the data can meet expectations for the FDA review of new products.
Recommendations and a robust toolkit to help drive a Quality by Design (QbD) approach, which engages a broad range of stakeholders and focuses resources on the errors that matter to decision making.

Both the webinar and CTTI’s latest recommendations and resources can be found on CTTI’s website.

CTTI Releases New Recommendations and Resources for Using Real-World Data to Plan Trial Eligibility Criteria and Recruit Participants

Posted on October 17, 2019February 10, 2025 by Hannah Faulkner

CTTI Releases New Recommendations and Resources for Using Real-World Data to Plan Trial Eligibility Criteria and Recruit Participants

CTTI Unveils New Recommendations for Using Real-World Data Sources to Boost Trial Quality and Efficiency

Posted on October 17, 2019March 6, 2025 by Lorri Bingham

CTTI today released new recommendations, resources, and case studies for using electronic medical records (EHRs) and claims data to plan trial eligibility criteria and recruit participants. The work fills an important gap across the clinical trials ecosystem, where the potential benefits of real-world data (RWD) have been widely acknowledged, but few resources have emerged to lead sponsors and others through the process of formally integrating RWD into their trial designs.

“We are excited to unveil this comprehensive set of work, which enables the use of RWE to plan for appropriate eligibility criteria and optimal recruitment in clinical trials,” said CTTI Executive Director Pamela Tenaerts. “These recommendations add to CTTI’s growing portfolio of work focused on improving clinical quality and, when appropriate, embracing novel approaches for better trial design and execution.”

CTTI conducted research and collaborated with stakeholders across the clinical trials ecosystem to develop these recommendations and resources, including three case studies that elucidate the process of integrating RWD into trial design. The case studies offer a look into the specific challenges faced by each sponsor, how they used RWD to address those challenges, and what they learned along the way.

Other CTTI efforts related to the new work include:

Co-leading a proof-of-concept study to assess the feasibility of using the FDA Sentinel System infrastructure to conduct randomized clinical trials.
Recommendations on how to assess and design registries so that the data can meet expectations for the FDA review of new products.
Recommendations and a robust toolkit to help drive a Quality by Design (QbD) approach, which engages a broad range of stakeholders and focuses resources on the errors that matter to decision making.

The RWD recommendations, resources, and case studies can be found on CTTI’s website.

CTTI to Launch New Work Highlighting the Opportunities for Using Real-World Data to Enhance Trial Quality and Efficiency

Posted on September 16, 2019March 6, 2025 by Lorri Bingham

“Until now, there have been few resources available to help sponsors and others optimally integrate the use of RWD into their trial design,” said CTTI Executive Director Pamela Tenaerts. “The work we are launching today fills that gap—our new recommendations and resources provide a clear path for using EHR and claims data to help plan eligibility criteria and recruit for clinical trials in a way that enhances quality and efficiency.”

CTTI conducted research and collaborated with stakeholders across the clinical trials ecosystem to develop these recommendations and resources, including three in-depth case studies that detail the specific challenges faced by sponsors, how they used RWD to address those challenges, and what they learned along the way.

This project is one in a growing portfolio of CTTI work focused on improving quality in trials and embracing novel trial designs. Other related CTTI efforts include:

Recommendations and a robust toolkit to help drive a Quality by Design (QbD) approach, which engages a broad range of stakeholders and focuses resources on the errors that matter to decision making.
Co-leading a proof-of-concept study to assess the feasibility of using the FDA Sentinel System infrastructure to conduct randomized clinical trials.
Recommendations on how to assess and design registries so that the data can meet expectations for the FDA review of new products.

The webinar is open to the public and will begin at noon ET, featuring speakers Sudha Raman, Duke University, and Jack Sheehan, Johnson & Johnson/Janssen.

Article Outlines Lessons Learned from First Large Pragmatic Trial Using Sentinel

Posted on March 14, 2019March 7, 2025 by Lorri Bingham

A new article in Clinical Trials, co-authored by CTTI, outlines lessons learned from the planning phase of the implementation of a randomized controlled trial to improve treatment with oral anticoagulants in patients with Atrial Fibrillation (IMPACT-AFib) trial, the first large pragmatic clinical trial that used the Sentinel infrastructure. This work is part of CTTI’s larger effort to advance trials that use real-world data sources.

The FDA’s Sentinel System uses electronic health records (EHR) and insurance claims from 18 health plans and delivery systems covering about 45 million individuals enrolled in commercial health plans, in addition to 22 million Medicare recipients.

The IMPACT-AFib trial, launched in 2017 by collaborators including CTTI, identified patients with atrial fibrillation who were at high risk of stroke, and randomized them to either an early or delayed intervention. The Sentinel System helped the trial team assess the size of the potential trial population, examine baseline measurements, and determine there were significant gaps in care, which showed there was a need for the trial.

In selecting participants for the trial and conducting other planning analyses, the trial team used Sentinel’s common data model and reusable analytic programs, which accelerated the planning and budgeting for the trial while keeping member-level data safe.

The IMPACT-AFib team also considered limitations introduced by Sentinel, including the potential for misclassification due to the use of administrative claims data. Other lessons learned for developing health plan-based clinical trials include using a single IRB, involving patient representatives in protocol design, and timing the start of the trial and mailing of materials around open enrollment and other health plan initiatives.

Learn more about CTTI’s other work to increase the appropriate use of real-world data sources and real-world evidence in clinical trials for regulatory submission.

CTTI Article Finds that Patients and IRBs are Amenable to Early Enrollment Strategy

Posted on December 14, 2018March 7, 2025 by Lorri Bingham

A CTTI article recently published in JAMA Network Open shows that an early enrollment strategy for research on healthcare-associated pneumonia is acceptable to patients, investigators, and institutional review boards (IRBs). This strategy has the potential to speed enrollment in trials for critical new antibiotic therapies by allowing patients to be approached and consented to before being diagnosed with pneumonia.

Through its ABDD HABP/VABP Studies work, CTTI conducted qualitative interviews with 52 stakeholders—including patients at risk for pneumonia, caregivers, study investigators and coordinators, and IRB representatives—as part of formative research to assess the acceptability of the approach.

The study found that patients and caregivers had no concerns about patients being approached early and having their records monitored before they developed pneumonia. They believed that patients would be able to understand consent information before diagnosis, and shared their preferences for opt-out procedures.

IRB representatives were also supportive of an early enrollment strategy, and investigators and study coordinators indicated that the approach would not be burdensome.

Experts Explore Ways to Promote Use of Real-World Evidence in Clinical Trials: Latest CTTI Expert Meeting Summary Now

Posted on September 17, 2018March 7, 2025 by Lorri Bingham

The use of real-world evidence (RWE)—derived from sources such as electronic health records (EHR) and claims data—has the potential to provide a more complete picture of patient experiences, reduce costs, and offer unique insights into important scientific questions. At the same time, there are relatively few examples to inform efforts to integrate RWE into clinical trials, as well as a lack of consensus among researchers about valid approaches for leveraging these data sources.

To address this issue, CTTI convened an expert meeting in June 2018 to discuss best practices and needed resources for advancing the use of RWE in randomized clinical trials. The meeting (see one-page summary) included investigators, patients, regulators, technology experts, sponsor representatives, and other groups.

While participants agreed that the use of RWE could be a major step forward in clinical trials, they stressed the importance of recognizing and planning for its limitations, including inconsistent data reliability and quality. They also agreed that direct interaction with participants and the integration of various real-world data sources is critical for improving the depth and breadth of available data.

As the next step in its Real-World Evidence work, CTTI will develop recommendations and resources for incorporating RWE into randomized trials for regulatory submission.