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CTTI Paper Highlights Clinical Criteria that Can Help Identify Patients at High Risk of HABP/VABP

Posted on December 3, 2020March 5, 2025 by Hannah Faulkner

Although treatment of possible nosocomial pneumonia is common with patients in the intensive care unit (ICU) receiving respiratory support, more than half of those treated do not fit the standard clinical definitions of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). A new CTTI paper available online in CHEST® Journal, accompanied by an insightful editorial, “Heeding the Prophetic Call,” outlines how the use of simple clinical criteria may help to identify high-risk patients earlier and aid future research to improve prevention and treatment.

The paper highlights the Prospective Identification of Pneumonia in Hospitalized Patients in the ICU (PROPHETIC) study, a large, contemporary, prospective cohort clinical trial designed by CTTI that made several key observations.

“HABP/VABP is associated with high mortality and morbidity and may be caused by multidrug-resistant pathogens,” said John Farley, director of the Office of Infectious Diseases at the FDA. “Conducting clinical trials in HABP/VABP is challenging, and data to understand the patient population is critical to improve trial feasibility.”

The study sought to define the incidence of HABP/VABP in an ICU population and identify characteristics associated with the development of HABP/VABP to inform the design and conduct of future clinical trials.

The study determined that 32 percent of 4,613 prospectively identified high-risk patients received antibiotics for possible HABP/VABP. It was also determined that only 12 percent of the aforementioned high-risk patients fit the FDA Guidance standard clinical definition of HABP/VABP.

“These findings indicate that the burden of HABP and VABP is significant and there is also some concern about antibiotic overprescription in this high-risk population,” said Vance Fowler, professor of medicine at Duke University. “Receiving antibiotics is itself a risk factor for developing pneumonia, carries risks of adverse events, and may preclude eligibility for HABP/VABP clinical trial enrollment.”

Additionally, the manuscript highlights the common characteristics and treatment exposures researchers identified that were associated with increased odds of developing HABP/VABP in high-risk patients.

“Application of the study results to prospectively identify patients at highest risk for HABP/VABP may help to facilitate the conduct of innovative and efficient clinical trials,” said Pamela Tenaerts, executive director of CTTI. “This will help to promote development of optimal preventive, diagnostic, and treatment strategies to improve management of this disease.”

Learn more about CTTI’s work on HABP/VABP Studies.

Antibacterial Drug Development HABP/VABP Studies

Date Initiated/Completed: 10/04/2024

Topics Included: Ensuring Quality, Recruitment, Regulatory Submissions + Approvals

Program: Antibacterial Drug Development

SHARE TO:

Clinical trials of new antibacterial drugs for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) are critically needed but challenging to conduct.

Building on our streamlining HABP/VABP trials work, CTTI conducted a prospective, multi-center, observational study of the risk factors for HABP/VABP, with over 6,700 adult patients enrolled at 28 U.S. sites and seven European sites, and 800 pediatric patients enrolled at nine U.S. children’s hospitals.

The study, an analysis of cost drivers and formative research on an early consent approach, are informing resources to help you develop and streamline HABP/VABP clinical trial planning.  For example, patients at high risk for developing pneumonia could be approached and consented early, potentially before pneumonia symptoms develop so that fewer patients are excluded because they have already received 24 hours of effective antibacterial therapy.

Key Takeaways

What is the issue?

One of the challenges in planning the HABP/VABP pilot study is determining which patients to approach for early enrollment. A group of patients at risk for pneumonia is required, but selecting criteria based on existing literature will involve a tradeoff between sensitivity and specificity. Approaching only the highest risk patients (e.g., those on a ventilator for a pre-specified length of time) would likely yield a relatively high percentage of patients who go on to develop pneumonia. The drawbacks of this approach include 1) not including a mix of VABP and non-VABP HABP; 2) exclusion of a large group of other patients who go on to develop pneumonia in the hospital in absence of the highest risk factors; and 3) increased likelihood of exclusion due to current use of antibiotics. Using a more inclusive approach, such as enrolling patients with a history of aspiration or with chronic lung disease, would increase the total number of patients who ultimately develop pneumonia, but would decrease the proportion of enrolled patients that develop pneumonia. If the proportion of patients developing pneumonia is too low, it is possible that the time, effort, and money required to conduct a study using an early enrollment strategy would not result in a meaningful increase in the number of patients enrolled who ultimately meet study criteria for antibacterial therapy for HABP/VABP.

A risk factor study was conducted to better define the population at highest risk for developing HABP/VABP. These results, in combination with CTTI’s Recommendations for Streamlining HABP/VABP Clinical Trials, which include a proposal for early consent to increase enrollment, have informed the development of an early enrollment strategy. Resources for those planning to implement an early enrollment strategy are being developed.

Role	Name	Affiliation
Principal Investigator	Vance Fowler	Duke University
Project Manager	Sara Calvert	Clinical Trials Transformation Initiative
Social Science Lead	Amy Corneli	Clinical Trials Transformation Initiative
Team Member	Elizabeth Alexander	The Medicines Company
Team Member	Stephen Bergin	Duke University
Team Member	Karen Chiswell*	Clinical Trials Transformation Initiative
Team Member	Deborah Collyar	Individual Patient/Caregiver
Team Member	Heather Cross	Duke University
Team Member	Carisa DeAnda	Merck & Co, Inc.
Team Member	Helen Donnelly	Northwestern University
Team Member	Beth Evans	Duke University
Team Member	John Farley	Food and Drug Administration
Team Member	Karen Fusaro	Melinta Therapeutics
Team Member	Peidi Gu	Duke University
Team Member	Thomas Holland	Duke University
Team Member	Sebastiaan Hullegie	University Medical Center Utrecht
Team Member	Kristen Miller	Food and Drug Administration
Team Member	John Powers	National Institutes of Health
Team Member	Daniel Rubin	Food and Drug Administration
Team Member	Jonas Santiago	Food and Drug Administration
Team Member	David Sigel	National Institutes of Health
Team Member	Simone Shurland	Food and Drug Administration
Team Member	Jie-Lena Sun	Duke University
Team Member	Pamela Tenaerts	Clinical Trials Transformation Initiative
Team Member	Joshua Thaden	Duke University
Team Member	Rose Tiernan	Food and Drug Administration
Team Member	Joseph Toerner	Food and Drug Administration
Team Member	Henri van Werkhoven	University Medical Center Utrecht

Resources

Regulatory Submissions + Approvals | CTTI News

CTTI Paper Highlights Clinical Criteria that Can Help Identify Patients at High Risk of HABP/VABP

Although treatment of possible nosocomial pneumonia is common with patients in the intensive care unit (ICU) receiving respiratory support, more than half of those treated do not fit the standard...

Regulatory Submissions + Approvals

Antibacterial Drug Development HABP/VABP Studies

Clinical trials of new antibacterial drugs for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) are critically needed but challenging to conduct.

Site Planning

Real-World Data

Real-world data (RWD) and real-world evidence (RWE), collected through the routine delivery of health care, are potentially powerful tools for enhancing the quality and efficiency of clinical trials.

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...

Refine Your Selection

Formats

Stage of Trial

Real-World Data

Topics Included: Recruitment, Site Planning

SHARE TO:

Real-world data (RWD) and real-world evidence (RWE), collected through the routine delivery of health care, are potentially powerful tools for enhancing the quality and efficiency of clinical trials.

Leverage CTTI’s recommendations, resources, and case studies  to use RWD to evaluate trial eligibility criteria and recruit potential research participants. This approach, for many, can be a low-risk, high-reward way to bring increased efficiency, shorter timelines, and better patient access to research efforts.

What is the issue?

What CTTI project has been initiated to address the issue?

What are the objectives of CTTI's work on real-world data?

Describe how data from electronic health records (EHRs) and payment claims can be utilized to facilitate the planning and execution of clinical trials
Describe practical models and operational guidance for the use of RWD to evaluate potential sets of trial eligibility criteria and to recruit potential trial participants directly or via appropriate site selection, as well as provide practical considerations and example language for informed consent documents in trials using RWD or generating RWE

What is the anticipated impact of CTTI's work on real-world data?

How was evidence gathered to support our findings?

Project Team Members

Role	Name	Affiliation
EC Champion (emeritus)	Rich Platt	Harvard University
EC Champion	Joe Selby	Patient-Centered Outcomes Research Institute
Project Manager	Zachary Hallinan	Clinical Trials Transformation Initiative
Project Manager	Lindsay Kehoe	Clinical Trials Transformation Initiative
Project Manager	Gerrit Hamre*	Clinical Trials Transformation Initiative
Recommendations Advisory Committee	Maria Ali	The George Institute for Global Health
Recommendations Advisory Committee	Lauren Ariniello	Scripps Translational Science Institute
Recommendations Advisory Committee	Sarah Beeby	Clinithink
Recommendations Advisory Committee	Andrew Bier	Genentech - a member of the Roche Group
Recommendations Advisory Committee	Robert DiCicco	IBM Watson Health
Recommendations Advisory Committee	Angela Dobes	Crohn's & Colitis Foundation
Recommendations Advisory Committee	Steven Draikiwicz	Sanofi-Aventis
Recommendations Advisory Committee	Jan Horsky	Northwell Health
Recommendations Advisory Committee	Marcia Jones	Eli Lilly and Company
Recommendations Advisory Committee	Kristin VanGoor	Biogen
Recommendations Advisory Committee	Ying Wan	Becton, Dickinson and Company
Social Scientist	Brian Perry	Clinical Trials Transformation Initiative
Team Leader	Scott Evans	Society for Clinical Trials
Team Leader	Dianne Paraoan	Food and Drug Administration
Team Leader	Jane Perlmutter	Individual Patient/Caregiver
Team Leader	Sudha Raman	Duke University
Team Leader	Jack Sheehan	Janssen
Team Member	Naomi Aronson	Blue Cross Blue Shield
Team Member	Barbara Bierer	Harvard University
Team Member	Ken Carson	Flatiron
Team Member	Laura Chu	Genentech-a member of the Roche Group
Team Member	Cathy Critchlow	Amgen
Team Member	Lesley Curtis	Duke University
Team Member	Ruthie Davi	Medidata
Team Member	Kristin Dolinski	PhRMA
Team Member	M. Khair ElZarrad	FDA/CDER
Team Member	Ryan Ferguson	Department of Veterans Affairs
Team Member	Farhan (CJ) Hameed	Pfizer Inc.
Team Member	Jerry Heatley	Abbott
Team Member	Jessie Juusola	Evidation Health
Team Member	David Kronfeld	Medidata
Team Member	John Laschinger*	Food and Drug Administration
Team Member	Sarah Leatherman	Department of Veterans Affairs
Team Member	Claire Meunier	Evidation
Team Member	Eric Peterson	Duke University
Team Member	Estevan Santana	PhRMA
Team Member	David Thompson	Syneos Health
Team Member	Guneet Walia	Genentech - a member of the Roche Group

Organization affiliations are listed as active affiliations during the project.

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

Resources

Regulatory Submissions + Approvals | CTTI News

CTTI Paper Highlights Clinical Criteria that Can Help Identify Patients at High Risk of HABP/VABP

Although treatment of possible nosocomial pneumonia is common with patients in the intensive care unit (ICU) receiving respiratory support, more than half of those treated do not fit the standard...

Regulatory Submissions + Approvals

Antibacterial Drug Development HABP/VABP Studies

Clinical trials of new antibacterial drugs for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) are critically needed but challenging to conduct.

Site Planning

Real-World Data

Real-world data (RWD) and real-world evidence (RWE), collected through the routine delivery of health care, are potentially powerful tools for enhancing the quality and efficiency of clinical trials.

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...

Refine Your Selection

Formats

Stage of Trial

Informed Consent

Topics Included: Recruitment, Safety

SHARE TO:

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

Regulatory Submissions + Approvals | CTTI News

CTTI Paper Highlights Clinical Criteria that Can Help Identify Patients at High Risk of HABP/VABP

Although treatment of possible nosocomial pneumonia is common with patients in the intensive care unit (ICU) receiving respiratory support, more than half of those treated do not fit the standard...

Regulatory Submissions + Approvals

Antibacterial Drug Development HABP/VABP Studies

Clinical trials of new antibacterial drugs for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) are critically needed but challenging to conduct.

Site Planning

Real-World Data

Real-world data (RWD) and real-world evidence (RWE), collected through the routine delivery of health care, are potentially powerful tools for enhancing the quality and efficiency of clinical trials.

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...

Refine Your Selection

Formats

Stage of Trial

Recruitment

Topics Included: Ensuring Quality, Recruitment

SHARE TO:

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

Regulatory Submissions + Approvals | CTTI News

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...