Informed Consent

CTTI Presents at Society for Clinical Trials Annual Meeting

Posted on by Lorri Bingham

There will be several opportunities to learn how CTTI recommendations can improve quality and efficiency of your clinical trials at the Society for Clinical Trials (SCT) 37th Annual Meeting, taking place May 15-18, 2016. Presentations will include the release of recommendations from the Data Monitoring Committees Project, as well as tips for collaborating with patient groups when designing clinical trials. CTTI will also have two posters for viewing: one on improving the informed consent process and one on how CTTI is improving the quality and efficiency of clinical trials.

If you are attending the conference, we invite you to stop by and learn more:

SCT 37th Annual Meeting

Presentation: Recommendations from the Clinical Trials Transformation Initiative Data Monitoring Committee Project
Date & Time: Monday, May 16, 2016, from 10:45 AM-12:15 PM EST
Speakers: Dave DeMets, Karim Calis, Ray Bain, Annemarie Forrest

Click here to learn more about the DMCs project.

 

Poster: CTTI’s Recommendations for Improving Informed Consent
Date & Time: Monday & Tuesday, May 16 – 17, 2016
Speaker: Annemarie Forrest

Click here to view recommendations and tools from the Informed Consent Project.

 

Poster: The Clinical Trials Transformation Initiative: Improving the Quality and Efficiency of Clinical Trials
Date & Time: Monday & Tuesday, May 16 – 17, 2016
Speakers: Pamela Tenaerts, Martin Landray, Christine Pierre, Ted Lystig, Annemarie Forrest

 

Presentation: Collaborating with Patient Advocacy Groups at the Design Stage of Your Clinical Trial: Why It Is So Important
Date & Time: Tuesday, May 17, 2016
Speaker: Bray Patrick-Lake

Click here to view recommendations and tools from the Patient Groups in Clinical Trials Project.

 

 

CTTI Presents Innovations in Informed Consent at the AAHRPP Conference

Posted on by Lorri Bingham

In November 2015, CTTI released official recommendations for a new model of informed consent that places the focus back where it should be: the participant. This innovative approach to informed consent emphasizes the process, which should be an interactive, ongoing conversation between the participant and the research investigator or staff. Several tools are included within the recommendations, which were developed to assist researchers (at the site and sponsor) in implementing this strategy.

Today, two colleagues involved in CTTI’s Informed Consent Project, Michele Kennett and Ross McKinney, will present these recommendations at the 2016 Annual AAHRPP Conference. If you are attending this event, we invite you to attend this session and learn more about the project:

2016 Annual AAHRPP Conference
Conference Location: Longbeach, CA
Presentation Topic: Innovations in Informed Consent: the CTTI Project
Presentation Date & Time: Wednesday, April 20, 2016, from 10:30 AM – 11:45 AM
Speakers:

  • Ross McKinney, MD, MBA, Professor of Pediatrics, Duke University
  • Michele Kennett, JD, MSN, LLM, Director, Human Research Protections, University of Missouri

 

Don’t Miss CTTI Presentation at ACRP 2016

Posted on by Lorri Bingham

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.

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

Posted on 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.

CTTI’s Recommendations on Informed Consent to be Featured in Upcoming NIH Collaboratory Grand Rounds

Posted on by Lorri Bingham

NEW recommendations on Informed Consent

On Friday, January 8, Jennifer Lentz of Eli Lilly and patient advocate Jane Perlmutter will present CTTI’s actionable, evidence-based recommendations on informed consent at the NIH Collaboratory Grand Rounds webinar.

The proposed new model for the informed consent process places the focus back where it should be: the participant. Furthermore, the consent process should be an interactive, ongoing conversation between the participant and the research investigator or staff. We encourage anyone interested in improving clinical trial quality and efficiency to attend.

Webinar Topic: The Clinical Trials Transformation Initiative’s Informed Consent Project: Recommendations and Resources

Speakers:

  • Jennifer Lentz, Global Informed Consent Process Owner, Global Clinical Operations, Eli Lilly and Company
  • Jane Perlmutter, PhD, Patient Advocate

Date & Time: Friday, January 8, 2016 from 1:00 – 2:00 p.m. EST

Meeting Info: CLICK HERE to view webinar login details

Recording Now Available: Webinar Unveiling of CTTI’s Informed Consent Project Recommendations

Posted on by Lorri Bingham

On November 19, 2015, CTTI hosted a webinar to present a new model of the informed consent process that places the focus back where it should be: the participant. This webinar was the official unveiling of CTTI’s recommendations resulting from the Informed Consent Project. We are pleased to now share the recording of this webinar:

We encourage you to share this recording with your colleagues in the clinical trials enterprise.

To view recordings of other CTTI webinars, CLICK HERE.

Presenting CTTI Recommendations: Informed Consent

CTTI Project: Informed Conent

Webinar Presenters:

  • Jennifer Lentz, Global Informed Consent Process Owner, US CMS Coordinator, Global Clinical Operations, Eli Lilly and Company
  • Michele Kennett, Assistant Vice Chancellor for Research, Director of Human Research Protections, Director of MU Institutional Review Board, University of Missouri

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective:

Team members from CTTI’s Informed Consent Project unveiled the official recommendations resulting from this project. These recommendations propose a new model for the informed consent process that places the focus back where it should be: on the participant.

Focus on the Process: CTTI Recommendations for Improved Informed Consent

Posted on by Lorri Bingham

NEW recommendations on Informed Consent

CTTI recommends a new model for the informed consent process that places the focus back where it should be: on the participant. The consent process should be an interactive, ongoing conversation between the participant and the research investigator or staff. “Patients who really understand what they are agreeing to when they sign an informed consent document are much more likely to adhere to trial requirements and be retained for the entire timeframe of the trial,” notes patient advocate, Jane Perlmutter. “Thus, not only is excellent consenting better for patients, it will also lead to more efficient and less costly trials.”

At a CTTI-hosted webinar on November 19, 2015, sponsors will hear suggestions and learn about tools to help them restructure the informed consent process and document to be more participant-friendly while retaining key information. The webinar will also explore the benefits of e-consent and how appropriate and thorough research staff training can improve the overall process for everyone involved.

The need for this new direction is recognized. “The Association of Clinical Research Professionals (ACRP) supports the recommendations put forth by our partners in the Clinical Trials Transformation Initiative,” says Jim Kremidas, ACRP Executive Director. “We are confident these recommendations will result in a more efficient and higher quality informed consent process conducted by clinical research professionals. A clear understanding of the risks and expectations clinical trial participants face will enhance their experience and drive better quality research.”

You’re Invited! CTTI Recommendations for an Improved Informed Consent Process to be Unveiled in November 19 Webinar

Posted on by Lorri Bingham

 

Join CTTI on November 19, 2015, as they host a webinar to present a new model of the informed consent process that places the focus back where it should be: the participant. This webinar will be the official unveiling of CTTI’s recommendations resulting from the Informed Consent Project and it is open to the public. We encourage you to share this invitation with your colleagues in the clinical trials enterprise.

 

Webinar Title: Public Unveiling of CTTI’s Informed Consent Project Recommendations

Date & Time: Thursday, November 19, 2015 from 12:00 – 1:00 p.m. EST

Speakers:

  • Jennifer Lentz, Global Informed Consent Process Owner, US CMS Coordinator, Global Clinical Operations, Eli Lilly and Company
  • Michele Kennett, Assistant Vice Chancellor for Research, Director of Human Research Protections, Director of MU Institutional Review Board, University of Missouri

Webinar Login:

  • CLICK HERE to enter meeting.
  • Meeting Number: 732 884 847
  • 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)

NEW Publication: CTTI Convenes Expert Panel that Identifies 3 Topics Ripe for Reform

Posted on by Lorri Bingham

This week, Clinical Trials published Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel. This publication is the result of CTTI’s Informed Consent Project and is based on the expert interviews conducted with stakeholders who have long-standing experience with the informed consent process. The goal of these interviews was to identify limitations within the current informed consent process and actionable recommendations for change. Three major themes emerged from these interviews, namely reform of the informed consent document, enhancing participant understanding of the clinical research, and modification of IRB review.

“The consensus recommendations from the interviewees provide a framework for meaningful change in the informed consent process. Although some proposed changes are feasible for rapid implementation, others such as substantive reform of the informed consent document may require change in federal regulations.”
-B. H. Lorrell, et al.

Figure 1. Enhancing research participant understanding of a clinical trial. Derived from authors’ analysis of results from 25 interview transcripts.

TO READ THE PUBLICATION IN FULL, CLICK HERE.