CTTI News Archives - Page 30 of 42

Improve Clinical Trial Recruitment: Join Us for a Webinar Unveiling CTTI’s New Recommendations & Tools

Posted on May 4, 2016July 9, 2021 by Lorri Bingham

Patient recruitment is a leading challenge in the efficient completion of clinical trials, with as many as 40% of clinical trials failing to meet recruitment goals. Too often, recruitment planning is an afterthought in clinical trial development, leading to increased costs and delays in bringing new therapies to market.

After reviewing evidence on obstacles and approaches to clinical trial recruitment, CTTI’s multi-stakeholder Recruitment Project team has developed new recommendations and tools to improve recruitment across the clinical trial enterprise.

Please join CTTI for an informational webinar on May 19, 2016, from 12:00 – 1:00 p.m. EST (GMT-04:00), to review these recommendations and tools developed to help clinical trialists meet their patient recruitment goals. In this session, patient recruitment managers, program and portfolio directors, clinical trial sponsors and designers, and clinical investigators 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 webinar is open to the public, and we encourage you to share this invitation with your colleagues in the clinical trials enterprise.

Webinar Title: CTTI Presents Recommendations for Recruitment: Moving Recruitment Planning Upstream to Reduce Barriers

Date & Time: Thursday, May 19, 2016, from from 12:00 – 1:00 p.m. EST (GMT-04:00)

Speakers:

Jonca Bull, MD, Director, Office of Minority Health, US Food and Drug Administration
Elizabeth Mahon, JD, Associate Director Global Clinical Operations â€“ US, Janssen R&D

Webinar Login: CLICK HERE to enter meeting.

*After you connect to the website, please follow step-by-step instructions for connecting to the audio.

If you prefer to connect to audio only, you can join by phone at:
1-855-244-8681 Call-in toll-free number (US/Canada)
1-650-479-3207 Call-in toll number (US/Canada)

CTTI Reveals Findings from Pediatric Antibiotic Trials Project at PAS 2016

Posted on April 27, 2016March 10, 2025 by Lorri Bingham

Conducting antibacterial trials in pediatric populations has unique challenges, which have contributed to the overall complexity of antibacterial drug development. CTTI’s Pediatric Antibiotic Trials Project aims to identify barriers related to scientific and operational issues in the design and conduct of clinical trials of antibacterial drugs for children, as well as develop recommendations to address these challenges.

After conducting surveys with investigators of pediatric antibiotic clinical trials and community providers, conducting qualitative interviews with parents and industry representatives, and reviewing information in the ClinicalTrials.gov database, we now have a body of evidence to inform this discussion. Findings indicate a multiplicity of real and perceived modifiable barriers to participating in or conducting pediatric antibacterial clinical trials, the need for deeper engagement with parents, and the necessity of effective recommendations to improve the design and conduct of these trials. These findings will be presented at the Pediatric Academic Societies (PAS) 2016 Meeting in Baltimore, MD on April 30 – May 3, 2016.

Poster Topic: Pediatric Trials in Antibacterial Drug Development: Findings from the Clinical Trials Transformation Project
Location: Exhibit Hall F
Date & Time: Saturday, April 30, 2016, from 1:30 – 2:45 PM EST
Speaker: Brian Smith, Duke University School of Medicine

CTTI Presents on QbD at Data Quality & Technology In Clinical Trials Conference

Posted on April 18, 2016March 10, 2025 by Lorri Bingham

On Tuesday, April 19, 2016, team leaders from CTTI’s Quality by Design (QbD) project, Ann Meeker-O’Connell and Mark Behm, will present at eyeforpharma’s Data Quality & Technology In Clinical Trials Conference.

This presentation, Examine the value proposition’s implication on trial design, will feature CTTI’s official Quality by Design Recommendations. These recommendations explore specific ways that quality can be built into the scientific and operational design and conduct of clinical trials.

We look forward to connecting with colleagues in the clinical trials enterprise at this event.

NIH and FDA Release Clinical Trial Protocol Template

Posted on April 15, 2016August 12, 2021 by Lorri Bingham

On March 17, 2016 the National Institutes of Health (NIH) together with the Food and Drug Administration (FDA) released for public comment a draft clinical trial protocol template for phase 2 and 3 Investigational New Drug application (IND) / Investigational Device Exemption (IDE) studies. Comments are being accepted until April 17, 2016. The goal of this effort is to allow investigators to more easily prepare protocols that are consistently organized with all the necessary information for review. The agencies welcome and encourage feedback from those involved in the clinical trial enterprise, including investigators, sponsors, members of institutional review boards, and other stakeholders, to help create a robust template for use with future protocols.

Efforts such as this template help to ensure consistency while streamlining protocol development and meeting regulatory requirements. CTTI is a proponent of an efficient, quality-driven, streamlined approach to the design, development, and conduct of clinical trials. Providing materials and resources to facilitate trial design and development is aligned with the CTTI Quality by Design (QbD) approach, and such tools can be easily integrated into clinical trial development plans. CTTI supports and applauds the NIH and FDA for their initiative and encourages similar work.

The draft template released by the NIH and FDA is available here. CTTI recommendations on how QbD principles can be applied to improve the quality and efficiency of clinical trials can be found here.

CTTI Executive Director to Speak at Harvard Webcast, The Forum

Posted on April 14, 2016July 9, 2021 by Lorri Bingham

Tomorrow, CTTI’s Executive Director Pamela Tenaerts will be speaking on an expert panel for The Forum at Harvard T.H. Chan School of Public Health, a live webcasting series that aims to provide decision-makers with a global platform to discuss policy choices and scientific controversies.

This Forum will explore the challenges and complexities of drug trials, and how they impact disease treatment and prevention – particularly for conditions that currently have little or no therapeutic options. As a case study, the panel will discuss Alzheimer’s and several drugs in development for that disease, but also address broader concerns related to the pharmaceutical testing pipeline for unmet medical needs as a whole.

Webinar: DRUG TRIALS: Challenges for Alzheimer’s and Other Urgent Needs
Date: Friday, April 15, 2016
Time: Noon-1 PM ET

Below, you can find information about joining the conversation in real time:

Live tweet with @ForumHSPH #drugtrials
Questions for panelists can be sent to theforum@hsph.harvard.edu

If you are unable to attend the webcast tomorrow, a recording of this event will be available next week and we will provide updates on the CTTI blog.

CTTI Acknowledged for Contributing to FDA Sentinel Program in Applied Clinical Trials News Article

Posted on April 13, 2016July 9, 2021 by Lorri Bingham

The Food and Drug Administration’s (FDA) Sentinel program was launched in 2008 and has been a considerable investment for the FDA, as indicated by Janet Woodcock in a recent Applied Clinical Trials news article. The Sentinel system is an important part of routine safety surveillance for pharmaceuticals and other medical products. The FDA plans to expand use of the Sentinel system to public health and quality improvement activities as well as effectiveness research in its “Guardian” system.

CTTI supported FDA efforts to explore the potential for using the Sentinel database beyond safety surveillance previously; CTTI and FDA’s Mini-Sentinel jointly published a report describing the capability and willingness of Mini-Sentinel’s Data Partners to collaborate in a variety of types of randomized trials, using the Mini-Sentinel (now Sentinel) Distributed Dataset. CTTI and Sentinel are now collaborating to design and implement a trial based on findings in the report. As mentioned in the recent Applied Clinical Trials news article, CTTI will facilitate the development and execution of a protocol for a randomized trial (IMPACT-AF) to study an educational intervention to improve the appropriate use of anti-coagulation for atrial fibrillation. This trial is a proof of concept study intended to determine whether it is possible to conduct a trial within the “Guardian” system. CTTI is proud to support the FDA’s efforts to expand their safety monitoring system to become a national resource with broader applications, specifically in more real-world clinical studies.

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.

FDA Calls For More Patient Population Diversity in Clinical Trials; CTTI is Ready to Help

Posted on April 6, 2016August 12, 2021 by Lorri Bingham

Historically, many clinical trial populations have lacked diversity and comprised predominantly white men. Because it is important that trial populations are representative of the actual patients to be treated with the investigational product, the U.S. Food and Drug Administration (FDA) has made a call for increased diversity in clinical trial participants. An article authored by FDA Commissioner Robert Califf in FDA Voice summarizes the current issues with trial recruitment and how the lack of participant diversity affects the evaluation of investigational drugs. Data gathered by the FDA show that “some groups, especially ethnic and racial groups, aren’t always represented in clinical trials” and that “these data are critical because certain groups of patients may respond differently to therapies.” His point is well supported by examples of underrepresentation of certain demographics in cardiovascular and schizophrenia trials and the resulting consequences.

In response to the need for greater trial population diversity, the FDA has planned or initiated several activities to encourage greater inclusion: the Diverse Women in Clinical Trials initiative, collaboration with the National Library of Medicine, and engagement with patient advocacy groups. Many of these activities are aligned with the goals of CTTI projects. For example, the CTTI Recruitment Project is developing communication planning approaches to engage all eligible participants and providers, including minorities and underrepresented populations. Furthermore, based on the results of the Informed Consent Project, CTTI recommends that the informed consent process be customized to meet the needs of each individual, and that those obtaining consent are trained to be responsive to potential research participants unique needs and concerns; these measures may help less health-literate participants feel comfortable participating in clinical trials. Finally, CTTI’s Patient Groups and Clinical Trials Project has provided recommendations on best practices for effective engagement with patient groups, which can facilitate involvement of patients from all walks of life.

CTTI is in agreement with the FDA’s call to action and is well positioned to provide support.