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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.
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“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.
New CTTI Publication Promotes Quality by Design Principles to Enhance Clinical Evidence
The growing cost and complexity of clinical trials is threatening the ability to generate new evidence to improve healthcare. CTTI’s latest publication, Enhancing Clinical Evidence by Proactively Building Quality Into Clinical Trials, from the Quality by Design (QbD) Project summarizes recommendations and tools for streamlining clinical. The QbD framework aims to promote critical thinking about trial design and oversight to reduce errors that matter while eliminating non-essential activities. By applying these principles, efforts can be focused on activities that are necessary for the reliability of trial findings and the protection of study participants.
The official QbD recommendations were released in 2015. In the recent publication, the authors describe the process for recommendation development in which stakeholders from across the clinical trial enterprise, including patient advocates, clinical investigators, regulatory reviewers, and trial sponsors, contributed perspectives through workshops and qualitative interviews.
The article was published in the journal Clinical Trials. To read the full publication, click here.
Learn About CTTI at FDA’s Regulatory Education for Industry (REdI) Conference
At the Regulatory Education for Industry (REdI) Conference, regulatory educators from the U.S. Food and Drug Administration (FDA) provide information to small drug and device manufacturers. On May 18, 2016, Kristen Miller, PharmD of OMP/CDER, will provide an overview of CTTI. CTTI was co-founded as a public-private partnership between Duke University and the FDA and develops projects culminating in recommendations and tools for transformational changes to clinical trials.
The presentation will review why CTTI was created, its mission and vision, CTTI’s array of projects, recommendations and implementation tools available, and how implementing the proposed changes could help to improve the clinical trial enterprise. CTTI was established as a public-private partnership between Duke and FDA and now comprises over 70 member organizations representing all stakeholders from across the clinical trials enterprise.
If you are attending the conference, we invite you to attend the session:
REdI Spring 2016 Conference
Conference Location: Bloomington, Minnesota
Topic: Increasing the Quality and Efficiency of Clinical Trials: The Clinical Transformation Trials Initiative (CTTI)
Date & Time: Wednesday, May 18, 2016, from 1:00-2:00 PM
Speaker: Kristen Miller, FDA/CDER
CTTI’s New Recommendations for Data Monitoring Committees
Today, CTTI unveiled new recommendations on best practices for the use of Data Monitoring Committees (DMCs), an important approach to ensure the validity and integrity of a clinical trial when there is a need to periodically review accumulating safety and efficacy data and advise on whether to continue, modify, or terminate a trial based on the benefit-risk assessment.
CTTI recommendations are intended to enhance the functioning of a DMC, beginning with the training of members. Other issues addressed by CTTI include the role and responsibilities of the DMC, composition of members, development of a charter, and communication with the trial sponsor and others. The recommendations were presented during a session at the Society of Clinical Trials (SCT) annual meeting. Dr. David DeMets, a thought leader on DMCs, chaired a session that also included project team members Karim Calis of FDA, Raymond Bain of Merck Research Laboratories, and Annemarie Forrest of CTTI.
As noted by Dr. Calis,
“DMCs play a unique and critical role in trial oversight. The clinical trial enterprise–including investigators, sponsors, trial participants, and other stakeholders–benefits greatly from having strong, independent DMCs that have adequate resources and sufficient flexibility to carry out their important mission.”
The full recommendations are available on the CTTI website and will also be presented in a CTTI-hosted free, public webinar on June 16, 2016 from 12:00 – 1:00 PM EST (New York, GMT-04:00). See below for additional details on this upcoming webinar:
Speakers:
- Dave DeMets, PhD, Professor and Chair of the Department of Biostatistics and Medical Informatics, University of Wisconsin – Madison
- Jane Perlmutter, PhD, Patient Advocate
- Karim Calis, PharmD, MPH, FASHP, FCCP, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Meeting Link: Click here to join WebEx meeting on June 16
Meeting number: 732 840 380
Meeting password: DMCctti
Or join by phone only:
1-855-244-8681 Call-in toll-free number (US/Canada)
1-650-479-3207 Call-in toll number (US/Canada)
Access code: 732 840 380