New Publication: CTTI Presents Stakeholder Survey Results on Barriers and Solutions to Clinical Trial Recruitment

This week, Applied Clinical Trials published Barriers to Clinical Trial Recruitment and Possible Solutions: A Stakeholder Survey. This publication is the result of the CTTI Recruitment Project Team’s efforts to gain a deeper understanding of stakeholders’ perceived barriers to recruitment across the clinical research enterprise. Several stakeholder groups, including clinical trial sponsors (industry, federal, and academic), research sites (investigators, coordinators, and executive-level staff), and patient advocacy organizations, were polled to gather information on approaches that will improve patient recruitment and enable trials to meet recruitment goals. The significant barrier most often cited by respondents was that of finding or identifying patients who meet eligibility criteria. A solution to this barrier that was proposed by a respondent was to broaden the eligibility requirements to enroll individuals more representative of the actual population. To improve recruitment efforts, respondents felt that medical record and hospital-based registry or database review were effective and often successfully employed. Additionally, building relationships and establishing referral programs with trusted clinicians were considered crucial to enhance recruitment. Overall, the majority of respondents had a positive outlook on the potential to increase recruitment rates over the next decade.

 

“The positive outlook on increasing clinical trial recruitment over the next 5 to 10 years among respondents is encouraging of the potential for progress to be made. It is apparent that a comprehensive recruitment strategy, rather than a single tool or solution, will be required to address the range of significant recruitment barriers identified.” – E. Mahon, et al.

 

To read the publication, click here.

Recently Released: Expert Meeting Summary on DMC’s

On July 28 – 29, 2015, CTTI’s Data Monitoring Committee Project hosted an expert meeting. The objectives of this multi-stakeholder meeting were to:

  • Present findings and conclusions from the project survey and focus groups
  • Share and solicit feedback on proposed Data Monitoring Committees (DMCs) recommendations

The summary is now available online.

CTTI Presents on Cost Drivers of HABP/VABP Phase Three Clinical Trials at ICAAC/ICC 2015

We are pleased to announce that CTTI’s HABP/VABP Trials Project will be presenting a poster at ICAAC/ICC 2015. In September, the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and the International Congress of Chemotherapy and Infection (ICC) will host this conference, intended for clinical microbiologists, infectious disease physicians, researchers, and pharmacists.

Session Details:

  • Title: Cost Drivers of Hospital Acquired Bacterial Pneumonia and Ventilator Associated Bacterial Pneumonia (HABP/VABP) Phase Three Clinical Trials
  • Date: September 18, 2015
  • Time: 12:00 – 2:00 PM
  • Presenter: Stella Stergiopoulos

We look forward to connecting with colleagues at this event.

CTTI’s QbD Recommendations & Toolkit to be Featured in Upcoming NIH Collaboratory Grand Rounds

On August, 21, 2015, the recommendations and Toolkit resulting from CTTI’s Quality by Design Project will be featured in an NIH Collaboratory Grand Rounds webinar. QbD Team Leaders Ann Meeker-O’Connell of Johnson & Johnson and Mark Behm of AstraZeneca will be presenting.

“This toolkit represents a compilation of documents, guidelines, forms, and videos that will help you put Quality by Design into operation within your organization. It’s been developed by professionals from across the entire spectrum of the clinical trials endeavor.”
– Mark Behm, AstraZeneca

Webinar Details:

We encourage you to share this invitation with colleagues involved in the clinical trials enterprise.

#InnovationThroughCollaboration

New CTTI Webinar Available Online: An Introduction to QbD Recommendations & Toolkit

On July 16, 2015, the Quality by Design (QbD) project team presented the QbD recommendations and an introduction to the QbD Toolkit. Released on June 15, 2015, this web-based Toolkit provides resources for facilitating adoption and real world application of QbD concepts. Whether you are first learning about QbD, want to disseminate these concepts within your organization, or are ready to implement QbD into your clinical trial, this Toolkit has resources for you.

recording of this webinar is now available on the CTTI website.

Webinar Invitation: CTTI’s Recommendations & Toolkit for Implementing QbD in Clinical Trials

CTTI invites you to participate in a webinar hosted by the Quality by Design Project Team. During this webinar the project team will present the Quality by Design (QbD) recommendations and provide an introduction to the QbD Toolkit, released June 15, 2015. This web-based Toolkit provides resources for facilitating adoption and real world application of QbD concepts.

Topic: Quality by Design Project: Recommendations and Toolkit

Date: Thursday, July 16th, 2015

Time: 12:00 p.m. – 1:00 p.m. EST (New York, GMT-05:00)

Presenters:

  • Ann Meeker-O’Connell, Head, Risk Management and External Engagement, Johnson & Johnson BioResearch Quality & Compliance
  • Coleen Glessner, MBA, Quality Expert
  • Martin Landray, Clinical Trials Service Unit & Epidemiological Studies Unit, University of Oxford

To join:

  • Meeting Link: Click here
  • Meeting Number: 735 985 012
  • Meeting Password: ctti
  • 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)

 

To view recordings of past CTTI QbD webinars, click here.

This webinar is open to the public. We encourage you to forward this invitation to others who may be interested in learning more about the QbD project’s recommendations and Toolkit.

What is Quality by Design?
Quality by Design (QbD) is an approach that focuses effort on those “errors that matter” for the success of the clinical trial. By prospectively examining the objectives of a trial and defining factors critical to meeting these objectives, action can be taken to prevent important risks to these critical factors from negatively impacting outcomes. Understanding what data and processes underpin a successful trial is essential to subsequently identifying and managing important and likely risks to improve quality and outcomes for clinical trials. For more information about QbD, click here.

CTTI Releases New Recommendations & Toolkit to Help Organizations Implement Quality by Design

The Clinical Trials Transformation Initiative (CTTI) has issued recommendations to improve the quality and efficiency of clinical trials by helping sponsors to focus on study activities that are essential to the safety of trial participants and the reliability of study results, and to reduce or eliminate those activities that are not.

Recognizing that time and resources are finite, CTTI encourages sponsors to build quality into the scientific and operational design and conduct of a clinical trial. CTTI defines “quality” in clinical trials as the absence of errors that matter to decision making–that is, errors which have a meaningful impact on the safety of trial participants or reliability of the results (and thereby the care of future patients).

“CTTI’s recommendations put the patient perspective at the center of the process by proactively identifying and managing those aspects of clinical trials most likely to negatively impact trial participants. Patient advocates readily understand the need to focus on errors that matter rather than spreading effort and attention thinly across all potential errors,” said Nancy Roach, founder and chair of the board of Fight Colorectal Cancer.

CTTI recommends sponsors create a culture that values and rewards critical thinking and open dialogue about quality, and that goes beyond sole reliance on tools and checklists; focus effort on activities that are essential to the credibility of the study outcomes; involve the broad range of stakeholders in protocol development and discussions around study quality; and prospectively identify and periodically review the critical to quality factors.

toolkit is available to help sponsors implement the recommendations. Included in the toolkit are resources that can facilitate proactive, cross-functional dialogue and decision-making about trial design and planning. For example, the Critical to Quality Factors document can help sponsors to focus on the critical to quality factors when designing clinical trial protocols. The critical to quality factors are not intended to be a simple check-list but to stimulate discussion and prioritization of the most critical determinants of a trial’s quality and formulation of an appropriate plan to define, avoid, mitigate, monitor and address important and likely risks to study quality.

“CTTI’s recommendations emphasize the importance of prospectively building quality into the scientific and operational design of clinical trials, rather than relying only on retrospective monitoring, inspection or scientific review. This systematic, proactive, and focused approach is compatible with FDA guidance on risk-based monitoring,” noted Robert Temple, M.D., Deputy Center Director for Clinical Science at the U.S. Food and Drug Administration (FDA).

The recommendations and toolkit have been formally unveiled during a presentation at the DIA annual meeting.

*For a link to a PDF of this press release, click here.

CTTI to Unveil Official Recommendations & Preliminary Project Findings at #DIA2015

CTTI will unveil official recommendations of the Quality by Design (QbD) Project at the DIA’s 51st Annual Meeting in Washington, DC. Quality by Design is an approach to clinical development that prospectively examines the objectives of a clinical trial and defines factors critical to meeting those objectives. These recommendations and an associated toolkit will assist organizations to implement QbD principles within their trials.

Additionally, at this conference, CTTI will share preliminary findings from projects on data monitoring committeesIND safety reportingrecruitment, and patient group engagement. As always, we look forward to connecting with our colleagues at this event. See below for details regarding CTTI’s presence at #DIA2015:

SessionClinical Quality by Design: From Theory to Practice
Date: June 15, 2015 from 11:00 AM – 12:30 PM
Presenters: Ann Meeker-O’Connell, Chair (Janssen), Coleen Glessner (Pfizer), Jean Mulinde (CDER/FDA), James Streeter (Oracle Health Sciences)

SessionThe Clinical Trials Transformation Initiative Data Monitoring Committee Project: Findings and Next Steps
Date: June 15, 2015 from 11:00 AM – 12:30 PM
Presenters: Susan Ellenberg, Chair (University of Pennsylvania), Ray Bain (Merck), Karim Calis (FDA), Jane Perlmutter (Patient Representative)

SessionTranslating New Knowledge from Regulatory Science into Postmarketing Safety Practice
Date: June 16, 2015 from 3:30 PM – 5:00 PM
Presenters: Gerald Dal Pan, Chair (FDA), Michael Jones (Eli Lilly), Darrell Abernethy (FDA), Peter Richard Arlett (EMA)

SessionBest Practices for Effective Engagement with Patient Groups Around Clinical Trials
Date: June 17 from 3:30 PM – 5:00 PM
Presenters: Bray Patrick-Lake, Chair (CTTI), Wendy Selig (WSCollaborative), Matthew Harker (CTTI), David Leventhal (Pfizer)

Poster: Results of An Online Survey of Stakeholders Regarding Barriers and Solutions to Clinical Trial Recruitment
Date: June 16 & 17 from 9:00 AM – 4:00 PM
Presenters: Jamie Roberts (CTTI), Elizabeth Mahon (Janssen)

For a complete list of CTTI’s upcoming events, please click here.

Recording Now Available: CTTI Webinar Provides Real-World Examples of QbD in Clinical Trials (Part 3)

Quality by Design (QbD) is an approach to planning clinical trials that involves building quality into the process from the beginning, where quality is defined as the absence of errors that matter to decision-making. While there is growing consensus around the idea that QbD can improve the quality and efficiency of trial design, questions remain about the implementation of these principles.

To address these questions, CTTI’s QbD Project has organized a three-part webinar series, which explores concrete examples of real-world application of QbD Principles. The third and final webinar in this series recently took place on April 15, 2015, featuring speakers from Johnson & Johnson and the University of Oxford who discussed how QbD has been executed within their organizations, as well as the lessons gleaned from their experiences.

We’re happy to share the recording of this webinar, and we encourage you to share it with your colleagues.

To view a recording of the first webinar in this series, click here.

To view a recording of the second webinar in this series, click here.

Mark your calendars for 12:00 PM EST on July 16, 2015! CTTI will be hosting a public QbD webinar to unveil our QbD toolkit. The QbD Toolkit will provide users with resources for:

  1. Promoting QbD concepts in their organization,
  2. Educating colleagues about QbD concepts via case studies, and
  3. Implementing QbD in real trials.