CTTI News

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.

CTTI Tackles 3 Issues in Clinical Trials with New Projects

Posted on by Lorri Bingham

At CTTI, we are continuously looking for practices that will increase the quality and efficiency of clinical trials. In 2014, three new topics have been added to our portfolio:

  1. Conducting Trials Using Data Registries: Demographic, disease, and outcome data collected in clinical observational registries often overlap with data gathered for clinical trials. Integrating clinical trials within observational data registries may offer opportunities to avoid duplicative data collection and increase efficiency while decreasing clinical trial costs. Objectives for this project include identifying upfront costs and operational adjustments required to utilize a data registry for a clinical trial, as well as recommending best practices for conducting randomized registry trials.
  2. Data Monitoring Committees (DMCs): As the use of DMCs has increased and evolved over the past 40 years, critical issues have emerged. A few of these issues include differences in DMC roles and responsibilities, which contributes to confusion and unclear expectations, as well as a lack of a clear plan for preparing the next generation of DMC members. Objectives for this project include understanding the current landscape of DMC use and conduct, clarifying the purpose of and rationale for using a DMC, and describing effective communication practices between independent DMCs and other trial stakeholders.
  3. Investigator Turnover: While an enormous amount of time and resources are spent initiating new investigators into the clinical trial process, there continues to be a high turnover rate for investigators. As many as 40% of investigators annually choose not to participate in another FDA-regulated trial. This high rate of attrition impacts site and overall trial performance. Objectives for this project include obtaining a more thorough understanding of the factors that influence investigators’ decisions to leave the clinical research practice, as well as defining the impact of investigator turnover on industry and society.

 

CTTI-Hosted Webinar Spotlights the Power of Collaborative Efforts in Rare Disease Areas

Posted on by Lorri Bingham

Webinar Video

The July edition of the CTTI-Hosted Webinar Series featured Sharon Hesterlee and Holly Peay, both of Parent Project Muscular Dystrophy. Titled “Patient Advocacy/Industry Partnerships to Accelerate Therapy Development,” this webinar provided an opportunity for Hesterlee and Peay to share several examples of collaborative efforts to advance the development of therapies for patients with Duchenne Muscular Dystrophy. Their stories show how engaging patient communities with their industry counterparts can result in real progress for those afflicted with this debilitating disease.

We invite you to watch a recording of this webinar, and we encourage you to share this resource with colleagues in the clinical trials enterprise.

 

CTTI-Hosted Webinar Spotlights Harvard’s Multi-Regional Clinical Trials Center

Posted on by Lorri Bingham

The March edition of the CTTI-Hosted Webinar Series featured Rebecca Li, Executive Director of the Multi-Regional Clinical Trials (MRCT) Center. She presented an update on MRCT programmatic activities, which focus on the following areas:

  • To improve the design, conduct, and oversight of multi-regional clinical trials, especially trials sited in or involving the developing world
  • To simplify research through the use of best practices
  • To foster respect for research participants, efficacy, safety and fairness in transnational, trans-cultural human subjects research.

At CTTI, we work with other initiatives to ensure complementary towards improving the clinical trials enterprise. We are pleased to share a recording of this webinar on our website.

Updated AACT Database Now Available on the CTTI Website

Posted on by Lorri Bingham

In an effort to characterize the U.S. clinical trials enterprise, CTTI’s State of Clinical Trials Project set out to facilitate the analyses of data in ClinicalTrials.gov, a registry of human clinical research studies hosted by the U.S. National Institutes of Health (NIH) in collaboration with the FDA. The result of this project was the Aggregate Analysis of ClincalTrials.gov (AACT) Database, 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 March 2014. To assist users with interpretation of the data, a high level dictionary and a points to consider document are also located on the CTTI website. Previous versions of AACT are available as well.