Quality
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
Improve Clinical Trial Recruitment: Join Us for a Webinar Unveiling CTTI’s New Recommendations & Tools
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 – 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 Presents on QbD at Data Quality & Technology In Clinical Trials Conference
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
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.
Don’t Miss CTTI Presentation at ACRP 2016
In the next week, the Association of Clinical Research Professionals (ACRP) will celebrate their 40th anniversary at the ACRP 2016 Meeting in Atlanta, GA. If you’re attending this conference, don’t miss the opportunity to learn about CTTI projects, directly from those working on them:
Topic: Improving Trial Recruitment and Informed Consent: Actionable Recommendations from CTTI
Date & Time: Monday, April 18, 2016, at 9:30 – 10:00 AM EST
Speakers:
- Zachary Hallinan, Director, Patient Communication and Engagement Programs, CISCRP
- Kelly McKee, Advisor, Clinical Innovation, Eli Lilly
- Gerrit Hamre, Clinical Project Manager, CTTI
To view the complete program for this conference, click here.
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.
FDA Calls For More Patient Population Diversity in Clinical Trials; CTTI is Ready to Help
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.
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.