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CTTI Work is Referenced in the FDA’s New Draft Guidance on Safety Assessment for IND Safety Reporting

Posted on by Lorri Bingham

The FDA issued a draft guidance in December 2015 on Safety Assessment for IND Safety Reporting. This guidance was developed as a follow-on to the 2010 guidance for Safety Reporting Requirements for INDs and BA/BE Studies and provides recommendations to help sponsors meet their obligations under 21 CFR 312.32. The FDA provides recommendations on the composition and role of a safety assessment committee, aggregate analyses for comparison of adverse event rates across treatment groups, planned unblinding of safety data, reporting thresholds for IND safety reporting, and development of a safety surveillance plan.

Page 4 of the guidance references CTTI work conducted by the IND Safety Project Team. (Recommendations developed during this project are available here.) The FDA addressed an observation that emerged during the IND Safety Project’s analysis of the evidence from surveys and multi-stakeholder expert meetings: sponsors have concerns about protecting trial integrity when reviewing serious adverse data from ongoing trials. To maintain trial integrity while assessing safety signals, the FDA recommends that sponsors use a safety assessment committee and develop a safety surveillance plan.

Comments on this draft guidance will be accepted until February 16, 2016.

CTTI continues to work in this area: the IND Safety Advancement Project is a follow-on to the IND Safety Project. This follow-on project seeks to promote full implementation of the FDA’s final rule by addressing particular challenges in oncology trials and generalizing solutions to other therapeutic areas.

CTTI Welcomes Newest Member Crohn’s & Colitis Foundation of America

Posted on by Lorri Bingham

CTTI would like to welcome our newest member, the Crohn’s & Colitis Foundation of America (CCFA).

CCFA is an organization focused on research, advocacy, and patient support for those suffering from Crohn’s disease and ulcerative colitis. CCFA’s Senior Director of Patient Services, James Testaverde, will represent this organization on CTTI’s Steering Committee.

We are pleased to have this new voice involved with CTTI’s work. CTTI actively engages all stakeholders equally to collaboratively improve the quality and efficiency of the clinical trials enterprise. For more information about the diverse representation of CTTI’s membership, click here.

Updated AACT Database Now Available on the CTTI Website

Posted on by Lorri Bingham

CTTI’s State of Clinical Trials Project set out to facilitate the analyses of data in ClinicalTrials.gov, by creating the database for Aggregate Analysis of ClincalTrials.gov (AACT), a restructured and reformatted relational database developed using publicly available and downloadable data from ClinicalTrials.gov. Since the original AACT was created in 2010, we’ve continued to regularly issue updated versions of the database.

The latest version of the AACT Database is now available on the CTTI website, along with the supporting documents. This dataset reflects data downloaded from ClinicalTrials.gov in September 2015. To assist users with the interpretation of the data, a comprehensive data dictionary and points to consider document are also available on the CTTI website. Previous versions of AACT are posted as well.

Since CTTI released the first AACT database five years ago, it has been utilized to answer many questions regarding the landscape of clinical trials.

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

Happy Holidays

Posted on by Lorri Bingham

Happy Holidays

In the past year, CTTI has made great strides in identifying and promoting practices to improve the quality and efficiency of clinical trials. As a result, 6 sets of recommendations were released in 2015 on the following topics:

  1. Increase understanding of research participants
  2. Involve patient groups as equal partners in clinical trials
  3. Create better protocols
  4. Facilitate the use of a single IRB of record
  5. Reduce inefficiencies of investigator training
  6. Develop a better safety reporting system

This could not have been done without the enthusiasm, support and engagement of CTTI members and others pursuing transformation in the clinical trials enterprise. We would like to express our gratitude for the effort that went into these recommendations and invite you to share these gifts with your colleagues. Together, we can achieve innovation through collaboration.

CTTI Provides Necessary Tools to Implement FDA Vision of Patient Engagement

Posted on by Lorri Bingham

As documented in a recent JAMA viewpoint article, the US FDA is making moves to integrate patient perspectives throughout the continuum of medical product development. While the FDA and other key stakeholders have declared a commitment to create a more effective model for engagement between research sponsors, investigators, and patient groups, no evidence-based guidelines for best practices have existed, until now.

On October 7, CTTI released recommendations that identify evidence-based best practices for engaging with patient groups, as well as provide case examples and tools. These recommendations are the result of CTTI’s Patient Groups & Clinical Trials Project.

How and when should patient groups be engaged in the research and development continuum? How do patient groups and sponsors of research best assess each other’s interests, expertise and assets to increase the chances of successful clinical trials and therapy development? We are proud to offer actionable solutions to these questions around patient engagement and encourage you to share them with colleagues involved in the clinical trials enterprise.

“The FDA is committed to integrating patient perspectives into its regulatory evaluations and decision making and also encourages medical product innovators and clinical researchers to collect information on patient perspectives to inform development programs.” (Source: JAMA)

CTTI’s Recommendations on Patient Engagement to be Featured in Friday’s NIH Collaboratory Grand Rounds

Posted on by Lorri Bingham

New Recs on Patient Engagement

On Friday, December 11, members from the Patient Groups & Clinical Trials Project will present CTTI’s actionable, evidence-based recommendations on effective engagement with patient groups at the NIH Collaboratory Grand Rounds webinar. We encourage anyone interested in promoting the patient voice in clinical research to attend.

Webinar Topic: CTTI’s Recommendations on Best Practices for Effective Engagement with Patient Groups Around Clinical Trials

Speakers:

  • Wendy Selig, Founder and CEO, WSCollaborative
  • Scott Weir, PharmD, PhD, Director, University of Kansas Medical Center

Date: Friday, December 11, 2015, 1:00-2:00 p.m. ET

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.

CTTI Welcomes New Members Alexion & PhRMA

Posted on by Lorri Bingham

CTTI would like to welcome our newest members, Alexion Pharmaceuticals, Inc. and Pharmaceutical Research and Manufacturers of America (PhRMA).

Alexion Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and delivering therapies for patients with rare diseases. Alexion’s Vice President of Research and Development Quality, Coleen Glessner, will represent this organization on CTTI’s Steering Committee.

PhRMA is a non-profit membership association that represents the country’s leading pharmaceutical research and biotechnology companies. PhRMA’s Senior Director of Science and Regulatory Advocacy, Jocelyn Ulrich, will represent this organization on CTTI’s Steering Committee.

We are pleased to have these two new voices involved with CTTI’s work. CTTI actively engages all stakeholders equally to collaboratively improve the quality and efficiency of the clinical trials enterprise. For more information about the diverse representation of CTTI’s membership, click here.