Author: Lorri Bingham

Participate in CTTI’s Survey on Data Monitoring Committees

Posted on by Lorri Bingham

We are inviting participants to a survey from the Clinical Trials Transformation Initiative (CTTI) to gather information about the current use and conduct of Data Monitoring Committees (DMCs). We aim to gain a deeper understanding of the purpose and rationale for using DMCs, goals and responsibilities of DMCs and current conduct and communications between stakeholders using this survey and future focus groups. Your input is critical as the survey results will be considered in developing recommendations on best practices for DMC use and conduct.

WHO IS BEING ASKED TO PARTICIPATE
Current and former DMC members; and representatives of research sponsors (government, industry and academic), clinical and academic research organizations (CROs/AROs) and statistical analysis centers who directly interact with DMCs. We encourage you to forward this email to qualified colleagues.

WHAT WE ARE ASKING OF YOU
You will be asked to complete one brief, electronic survey that should take less than 15 minutes to complete. The survey is anonymous; no unique identifier will link you to your responses. In this format, please note that it is therefore necessary that you finish the survey completely before exiting out of your web browser, as the survey will not save partial responses.

PLEASE CLICK ON THIS LINK TO COMPLETE THE ANONYMOUS SURVEY.

YOUR ANSWERS WILL BE TREATED CONFIDENTIALLY
We will not be able to link your personal information such as email address and name with your answers. Your answers will be combined with those from others, and we will report answers only in aggregate.

HOW YOUR INPUT WILL BE USED
The study results will be used by CTTI to develop additional investigational activities, such as focus groups and an expert meeting. Evidence gathered from these activities will support recommendations on best practices for DMC use and conduct, to be published and used to develop toolkits for the various stakeholder groups. For more information, go to https://ctti-clinicaltrials.org/our-work/ethics-and-human-research-protection/data-monitoring-committees/.

WHO WE ARE
CTTI is a public-private partnership, established by the US Food and Drug Administration (FDA) and Duke University, whose membership includes representatives from academic institutions, clinical research organizations, institutional review boards, patient groups, pharmaceutical, biological and device companies, professional societies, US government and other stakeholders within the clinical trials enterprise. CTTI conducts projects in support of its mission to identify and promote practices that will increase the quality and efficiency of clinical trials.

WHO TO CONTACT FOR QUESTIONS
You should direct any questions or concerns regarding your survey participation to CTTI (ctti-dmcproject@duke.edu). For questions or concerns about your rights as a research subject, you can also contact the Duke Institutional Review Board (IRB) at 919-668-5111.

Thank you for your consideration,

The Clinical Trials Transformation Initiative Data Monitoring Committee Project Team Leaders:

Patrick Archdeacon
U.S. Food and Drug Administration, Center for Drug Evaluation and Research

Raymond Bain
Merck Research Laboratories

Karim Calis
U.S. Food and Drug Administration, Center for Drug Evaluation and Research

David DeMets
University of Wisconsin-Madison

Jane Perlmutter
Patient Representative

Connect with CTTI on LinkedIn

Posted on by Lorri Bingham

CTTI is committed to improving the quality and efficiency of clinical trials. In the pursuit of effectively communicating this critical work, our social media presence has now expanded to LinkedIn. We encourage you to follow our Company Page to stay abreast of CTTI’s news and connect with your colleagues.

TO FOLLOW CTTI’S LINKEDIN COMPANY PAGE

This simple connection allows CTTI updates to come directly to you in your LinkedIn feed, enabling easier liking, commenting, and sharing of CTTI posts with your communities.

CTTI updates can also be viewed on our blog and Twitter. To view our catalog of videos, visit our Vimeo Page. We invite you to connect with us and help us in our mission.

Operationalizing QbD in Clinical Trials: Lessons from Industry

Posted on by Lorri Bingham

Quality by Design (QbD) is an approach to planning clinical trials that involves building quality into the process from the beginning. While there is growing consensus around the idea that QbD can improve the quality and efficiency of trial design, you may be wondering how these principles translate into practice.

On October 16, CTTI hosted a webinar featuring speakers from Pfizer and Seattle Genetics 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 continue the exploration of real-world applications of QbD principles in clinical trials, two additional webinars have been scheduled. Please mark your calendars for these dates:

  • Wednesday, January 14, 2015, 11:00 a.m. – 12:00 p.m. EST
  • Wednesday, April 15, 2015, 11:00 a.m. – 12:00 p.m. EST

If you would like to be added to our QbD webinar e-mailing list, contact Kimberley Smith (kimberley.i.smith@dm.duke.edu) to receive reminders of the upcoming webinars, as well as notifications of the recordings.

CTTI Welcomes New Member Dana-Farber Cancer Institute

Posted on by Lorri Bingham

CTTI would like to welcome newest member Dana-Farber Cancer Institute. As a leading organization in cancer treatment and research, it represents one of many key stakeholders that CTTI engages to collaboratively improve the quality and efficiency of the clinical trials enterprise. Michele Russell-Einhorn, Senior Director of the Office for Human Research Studies, will represent the organization on our Steering Committee, and we look forward to her contribution.

CTTI Presents on Overcoming Barriers to Effective Patient Engagement in Clinical Trials at DIA’s Upcoming Interactive Workshop

Posted on by Lorri Bingham

Bray Patrick-Lake, CTTI Director of Stakeholder Engagement, will discuss preliminary results of a CTTI-DIA patient engagement survey at the DIA workshop Patient Engagement throughout the Full Spectrum of Drug Development: An Interactive Workshop for Life Science Companies and Patient Groups.

Ms. Patrick-Lake will share the insights provided by more than 250 patient groups, investigators, and research sponsors on current US practices and perceived barriers for engaging with patient groups in clinical discovery and research, including clinical trial development and execution. Her talk will lead off a series of participatory discussions in which workshop attendees will share their perspectives on expectations and needed outcomes for patient engagement, current aspects that are working well, and problems that must be addressed to achieve meaningful improvement of engagement practices and outcomes.

This two-day workshop will be help on October 29-30, 2014 in Washington, DC. For registration information, CLICK HERE.

AdvaMed 2014 Conference Features Solutions to the Clinical Trial Crisis in Devices

Posted on by Lorri Bingham

Tomorrow morning, CTTI’s Executive Director Pamela Tenaerts will moderate a panel at the AdvaMed 2014 MedTech Conference in Chicago, IL. The panel, titled Solving the Clinical Trial Crisis in Devices, will focus on efforts to overcome increasing costs and inefficiencies in current clinical trial approaches for medical devices. Additionally, participants will learn how these efforts can improve the design and conduct of clinical trials within their own organizations.

The panelists for this session include:

  • Chip Hance, CEO, Creganna-Tactx Medical
  • William Maisel, M.D., MPH, Deputy Director for Science, FDA/CDRH
  • Roxana Mehran, M.D., FACC, Professor of Medicine (Cardiology), Health Evidence and Policy, Director of Interventional Cardiovascular Research and Clinical Trials, The Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, NY

Panel Time: 9:15 – 10:30 a.m.

Panel Location: W180

We look forward to engaging with our colleagues during this panel. If you are on Twitter, you can also connect with CTTI during #AdvaMed2014 via @CTTI_Trials.

ClinicalTrials.gov Registry Enables Review of Peripheral Vascular Disease Clinical Trials Portfolio

Posted on by Lorri Bingham

Peripheral Vascular Disease (PVD) poses a growing public health concern, particularly for the aging American population. While a high prevalence of vascular disease exists, and therapeutic advances have been made in this area, a systematic overview of the clinical trials portfolio for PVD has not been done, until recently.

A new Circulation publication, titled Clinical Trials in Peripheral Vascular Disease: Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database, utilized the CTTI-created AACT Database, a searchable relational database of content from ClinicalTrials.gov. The AACT Database allowed researchers to analyze interventional trials registered in ClinicalTrials.gov from October 2007 through September 2010 (n=40,970).

The author’s conclude,

PVD studies represent a small group of trials registered in ClinicalTrials.gov, despite the high prevalence of vascular disease in the general population. This low number, compounded by the decreasing number of PVD trials in the United States, is concerning and may limit the ability to inform current clinical practice of patients with PVD.*

To view the article online, CLICK HERE.

 

*Source: Sumeet Subherwal, Manesh R. Patel, Karen Chiswell, Beth A. Tidemann-Miller, W. Schuyler Jones, Michael S. Conte, Christopher J. White, Deepak L. Bhatt, John R. Laird, William R. Hiatt, Asba Tasneem, and Robert M. Califf, “Clinical Trials in Peripheral Vascular Disease: Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database,” Circulation, (Sept 19 2014).

CTTI-Hosted Webinar Provides Real-World Examples of Quality by Design (QbD) in Clinical Trials

Posted on by Lorri Bingham

The Clinical Trials Transformation Initiative (CTTI) invites you to participate in a webinar hosted by the Quality by Design (QbD) Project team. QbD emphasizes building quality into a process from the beginning. Applied to clinical development, this approach prospectively examines the objectives of a trial and defines factors (key data and trial processes such as randomization) critical to meeting these objectives. This webinar is the first in a CTTI-hosted series designed to provide real-world examples of applying QbD to clinical trials.

Topic: Translating Quality by Design Principles into Practice

Date: Thursday, October 16, 2014

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

Agenda:

  • CTTI Quality by Design Project Overview – Ann Meeker-O’Connell, Senior Director, Clinical Quality Strategy Team Lead, Janssen
  • Pfizer Experience – Coleen Glessner, Vice President, Clinical Trial Process and Quality, Pfizer
  • Seattle Genetics Experience – Marta Fields, Senior Director, Compliance and Quality Systems, Seattle Genetics
  • Q & A

This webinar is open to the public.

We encourage you to forward this invitation to others who may be interested in learning more about QbD implementation.

 

To join the webinar on October 16, go to:

https://dukemed.webex.com/dukemed/j.php?MTID=m27634ad504de56e6e23456b195047753

Meeting Number: 731 417 196

Meeting Password: ctti

For those wishing to access the audio conference only, please dial 1-855-244-8681(access code: 731 417 196).

The playback of UCF (Universal Communications Format) rich media files requires appropriate players. To view this type of rich media files in the meeting, please check whether you have the players installed on your computer by going to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

Mark your calendars. The QbD Webinar Series will continue on the following dates:

  • Wednesday, January 14, 2015, 11:00 a.m. – 12:00 p.m. EST (New York, GMT-05:00)
  • Wednesday, April 15, 2015, 11:00 a.m. – 12:00 p.m. EST (New York, GMT-05:00)

CTTI Welcomes New Member Medtronic

Posted on by Lorri Bingham

CTTI would like to welcome newest member Medtronic. As a leading organization in medical technology, they represent one of many key stakeholders that CTTI engages to collaboratively improve the quality and efficiency of the clinical trials enterprise. Distinguished Statistician Theodore Lystig, PhD will represent Medtronic on CTTI’s Steering Committee.

For more information about CTTI’s organizational structure, including the Steering Committee, CLICK HERE.

CTTI’s Announces New IND Safety Advancement Project

Posted on by Lorri Bingham

CTTI’s Executive Committee recently approved the IND Safety Advancement Project. This project is a follow-up to CTTI’s IND Safety Project, which issued recommendations in late 2013. These recommendations are intended to improve clinical trials by helping sponsors to ensure recognition of important safety issues for study drugs and biologics as early as possible during development.

Both of these projects were initiated in response to the FDA’s final rule published on September 29, 2010. This rule established new reporting requirements for serious and unexpected adverse reactions occurring in clinical trials conducted under an investigational new drug application (IND) (CFR 21.312). Although this rule, which was intended to improve the overall quality of safety, was published nearly four years ago, anecdotal reports indicate that implementation problems remain, particularly in oncology clinical trials.

While the original IND Safety Project sought to better understand current practices among sponsors for assessing and communicating the safety of an IND, the advancement project focuses on clarifying motivations and challenges to full implementation of the IND safety reporting rule. The anticipated impact of this new project is an increase in compliance with respect to assessment, communication, review, and management of serious adverse events and serious unexpected safety adverse reports.

Please visit the CTTI website for regular project updates.