Author: Lorri Bingham

The Possibilities of Conducting Randomized Clinical Trials using Electronic Data in the Mini-Sentinel Environment

Posted on by Lorri Bingham

On May 15th Richard Platt, MD, MS, of Harvard Pilgrim Healthcare, and Patrick Archdeacon, MD, of the FDA, spoke at a CTTI-hosted webinar titled Developing Approaches to Conducting Randomized Trials in the Mini-Sentinel Environment. During this teleconference, Platt and Archdeacon summarized the collaborative work of CTTI and Mini-Sentinel investigators exploring the potential for building on the Sentinel’s health-plan-based teams and data infrastructure to facilitate multi-center clinical trials. A recently released report, Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database, fully describes the project and results. Their talk concluded with an explanation of the follow-up phases of this work, which will likely include convening working groups to further advance the concepts put forth in this report and collaborating with other partners.

We are pleased to share the recording of this webinar with the public, and we encourage interested parties to learn more about the Mini-Sentinel.

 

Participate in our Survey on Current Practices for Engagement with Patient Groups in Clinical Discovery & Research

Posted on by Lorri Bingham

The Clinical Trials Transformation Initiative (CTTI) and the DIA are co-sponsoring a survey and we’re currently seeking participants. The results of this survey will be used to develop recommendations on Best Practices for Effective Engagement with Patient Groups Around Clinical Trials for CTTI’s purposes and the DIA Patient Engagement Workshop for DIA’s purposes. We aim to gain a deeper understanding of current US practices and perceived barriers for engaging with patient groups in all aspects of clinical discovery and research, including clinical trial development and execution. Your input is critical as the study results could lead to recommendations on best practices for effective engagement with patient groups.

WHO IS BEING ASKED TO PARTICIPATE

Organizational representatives of patient groups, investigators, research sponsors and clinical research organizations.

WHAT WE ARE ASKING OF YOU

You will be asked to complete one brief, 15-20 minute electronic survey. Please note that because the survey is anonymous it is necessary that you complete it before exiting out of your web browser as no unique identifier will link you to your responses.

PLEASE CLICK ON THIS LINK TO COMPLETE THE ANONYMOUS SURVEY:

https://duke.qualtrics.com/SE/?SID=SV_3PdDeqUB4DeLYKp

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 semi-structured interviews and an expert meeting, that lead to recommendations on best practices for effective engagement with patient groups around clinical trials, to be published and used to develop toolkits for the various stakeholder groups. For more information, go to http://bit.ly/1nJ3RPj.

DIA will conduct an interactive workshop for researchers and patient groups to discuss issues identified by the study results and effective approaches for resolution. More information about this DIA activity can be found at www.diahome.org. If you are interested in learning more about participation in CTTI”s investigational activities or DIA’s workshop please email ctti.diasurvey@dm.duke.edu for further information.

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.

DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Pa., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing).

WHO TO CONTACT FOR QUESTIONS

You should direct any questions or concerns regarding your survey participation to Bray Patrick-Lake at CTTI (bray.patrick-lake@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 CTTI Patient Groups & Clinical Trials Project Team Leaders:

  • Amy Abernethy, MD, PhD; Associate Professor of Medicine; Director, Center for Learning Health Care; Duke Cancer Research Program
  • Sharon Hesterlee, PhD; Parent Project Muscular Dystrophy, Sr. Director of Research & Advocacy
  • Richard Klein, FDA, Director of the Patient Liaison Program
  • David Leventhal, Pfizer, Director, Clinical Innovation, Worldwide Research & Development
  • Jamie Roberts, MA, CCRP; NIH, Clinical Trials Specialist, NINDS
  • Wendy Selig, MS; Melanoma Research Alliance, President and CEO
  • Sophia Smith, PhD, MSW; Associate Professor, Duke School of Nursing

DIA North America:

  • Debra Michaels, Senior Manager, Strategic Content & Policy Assessment

CTTI Presents at the SCT 35th Annual Meeting

Posted on by Lorri Bingham

On May 18-21, 2014, the Society for Clinical Trials (SCT) will be hosting the SCT 35th Annual Meeting in Philadelphia, PA. This meeting is intended for a wide range of professionals representing academia, the pharmaceutical and device industries, government agencies and medical groups and centers. We are pleased to announce that CTTI will be present at this conference to share the ideas and lessons generated from several CTTI projects:

  • Team Lead for CTTI’s Central IRB Advancement Project, Cynthia L. Hahn will be presenting in Invited Session 8: Using a Centralized IRB Review Process in the Conduct of Multi-center Trials.
  • CTTI’s Director of Stakeholder Engagement, Bray Patrick-Lake will be presenting in Invited Session 14: NINDS INSPIRE Workshop: Patient Engagement & Patient-Centeredness – A Holistic Approach to Clinical Trial Design & Implementation. Key points for this session are related to CTTI’s Patient Groups & Clinical Trials Project.
  • Bray Patrick-Lake will also be part of a team leading a pre-conference workshop on May 18, 2014. This half-day workshop (Workshop P7) will take place from 1:00 PM – 5:00 PM and will cover the Best Practices and Innovations in Patient and Community Engagement in Clinical Trials. Advance registration and payment are required for pre-meeting workshops. CLICK HERE to complete the registration form for the SCT 35th Annual Meeting.

We look forward to connecting with the presenters and attendees of the SCT 35th Annual Meeting. Together, we can facilitate change in the clinical trials enterprise.

INNOVATION THROUGH COLLABORATION

If you are attending this conference and active on Twitter, here’s what you need to know:

New Publication Points to Need for Aggregate Safety Data Reports in IND Research

Posted on by Lorri Bingham

This week, the journal Therapeutic Innovation & Regulatory Science published a peer-reviewed article, titled Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND, assessing the range of industry practices for safety monitoring and expedited reporting to U.S.-based investigators of IND research in late 2009.

In a small sample of survey respondents, most of whom represented relatively large pharmaceutical and biological companies, the authors found that these organizations maintain “robust structures, procedures, and staffing to manage large volumes of safety data and to meet specific requirements of expedited reporting to multiple regional and local regulatory authorities. However, their focus at the time of the survey was clearly on notification and assessment of individual case reports of SAEs. In contrast, respondents reported less emphasis on, and greater variation in, aggregate analysis, interpretation, and reporting of safety data. This pattern is consistent across multiple areas of safety data management, including procedures, clinical monitoring, use of external resources, and safety reporting.”

The authors concluded:

“These data suggest that investigators would likely benefit if industry sponsors decreased reporting of individual cases that are not readily interpretable and instead reported meaningful safety information from aggregate analyses.”

This publication resulted from CTTI’s SAE Reporting Project. For more information about this project, CLICK HERE.

Improving Human Health through Large Simple Trials

Posted on by Lorri Bingham

“Randomized clinical trials remain the most reliable means of identifying the drugs, devices, and treatment strategies that will improve human health.”
– Zubin J. Eapen, MD, MHS, Michael S. Lauer, MD, and Robert J. Temple, MD

On May 13-14, 2013, CTTI hosted an expert meeting on the need to streamline the conduct of large simple trials (LSTs) in the U.S. This meeting convened a broad array of engaged stakeholders including regulators, government sponsors of clinical research, members of academia and industry, patient advocates, clinical investigators, and other interested parties. The primary objective of this meeting included discussing the following:

  • Findings from a survey of practices
  • Strategies that companies are using to implement LSTs
  • The challenges to LSTs

The summary of this expert meeting is now available on the CTTI website.

Additionally, the key takeaways from this expert meeting were captured in a recent JAMA Viewpoint publication, The Imperative of Overcoming Barriers to the Conduct of Large, Simple Trials. Co-authored by three of CTTI’s LST Project Team Members (Zubin J. Eapen, MD, MHS, Michael S. Lauer, MD, and Robert J. Temple, MD), this perspective piece highlights how the U.S. healthcare system stands to benefit from larger, simpler, less expensive randomized trials. This article also touches on the possibility of leveraging existing data collection platforms to enhance patient enrollment in LSTs, as well as the ability of funding opportunities to encourage streamlined trial design.

The authors concluded, “With the current opportunities to streamline trials and leverage existing clinical data, conducting large, simple trials is more possible than ever and presents a path forward for advancing human health.”

For more information about CTTI’s LST Project, CLICK HERE.

Rethinking Clinical Research: Central IRB Advancement Webinar

Posted on by Lorri Bingham

On Friday April 25, 2014, the NIH Collaboratory’s free webinar series known as the Grand Rounds: Rethinking Clinical Research will host the web conference titled CTTI Advancing the Use of Central IRBs Project: Academic Institution and Government Sponsor Perspectives. The focus of this webinar will be the adoption of a single IRB of record for multi-center clinical trials, as encouraged in CTTI recommendations. Two speakers, both of whom serve as team leads for CTTI’s Central IRB Advancement Project, will be featured:

  • Cynthia Hahn, VP, Clinical Research and Regulatory Affairs, North Shore-LIJ Health System
  • Petra Kaufmann, M.D., M.Sc., Director, Office of Clinical Research, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

We invite you to attend this presentation, and encourage you to share this opportunity with your colleagues.

Time: 1:00-2:00 p.m. ET

Webinar Login:

  1. Log in to the URL first: https://dukemed.webex.com/dukemed/j.php?MTID=m30760324061a749812cd1c966d1bfde0
  2. Click “Audio Conference”
  3. Choose “I will call in” and select the Toll Free number.
  4. Dial in using the information from the dialog box that appears. Be certain to use the Access Code AND the Attendee ID.

*Note: If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 739 773 050
Meeting Password: 1234

For additional webinar details, please visit the NIH Collaboratory’s Grand Rounds Calendar.

We would like to thank Cynthia Hahn, Petra Kaufmann, and the rest of the Central IRB Advancement Team for their dedicated efforts to encourage implementation of CTTI’s recommendations. It is through these dissemination activities that methods to increase the quality and efficiency of the clinical trials enterprise are shared, and changes in practice are effected.

 

CTTI Tackles Practical Applications of Quality by Design at the DIA’s 50th Annual Meeting

Posted on by Lorri Bingham

DIA Meeting

This summer, the DIA will host their 50th Annual Meeting in San Diego, CA, bringing together “a global network of life sciences professionals to foster innovation that will lead to the development of safe and effective medical products and therapies to patients.” We are proud to announce that CTTI will be hosting a one-day, pre-conference tutorial, titled Quality by Design: From Theory to Practice, in conjunction with this event. This Quality by Design (QbD) tutorial is intended to give representatives from a broad cross-section of the clinical trials enterprise practical insights into applying QbD principles into their work. Emphasis will be placed on:

  • Developing an understanding of risk-based QbD for clinical trials, from general principles, real-world examples, and hypothetical case studies;
  • Gaining confidence in the application of building quality into the clinical trials process;
  • And identifying perceived barriers to the adoption of Quality by Design principles.

The QbD tutorial will be held on Sunday June 15, 2014, from 9 am – 5 pm, and will be co-instructed by Ann Meeker-O’Connell (Janssen), John Alexander (Duke), and Jean Mulinde (FDA/CDER). This pre-conference tutorial is open to any individual registered for the DIA conference. (To register for the DIA conference, CLICK HERE.)

*Note: There is limited availability for the pre-conference tutorial. To assure your seat, please sign up as soon as possible.

To view more information on CTTI’s ongoing QbD project, CLICK HERE.

CTTI’s Founding Executive Director Retires

Posted on by Lorri Bingham

In February of 2014, CTTI’s founding Executive Director Judy Kramer retired and today we’d like to pay tribute to her legacy. She most recently served as CTTI’s Senior Scientific Advisor and as Professor Emerita of Medicine at Duke. In addition to establishing this CTTI, Judy provided scientific guidance on individual CTTI projects and she played a significant role in communicating the results of these projects through publications and presentations at national and international meetings. She also advanced our mission by participating in the efforts of other non-profit organizations with similar goals.

Judy is known for her genuine passion and unfaltering conviction to improve and transform clinical trials, as well as her ongoing commitment to patient-centeredness and clinical trial safety issues. These attributes permeated through all of our interactions with her and aside from her valuable professional contributions to CTTI and Duke, Judy had a lasting positive personal influence on her colleagues.

Luckily for the clinical trial enterprise, Judy will continue to stay involved with FDA advisory committees. She will also likely have additional interactions with CTTI through her Professor Emerita role at Duke. Please join me in wishing Judy all the best in this next phase of her life, which will include a larger proportion of time devoted to travel, taking beautiful pictures, and her family. She and her husband, Lloyd, are looking forward to spending more time with their four granddaughters.

– Pamela Tenaerts, MD, MBA
Executive Director, CTTI

As a tribute to Judy’s years of service, we’d like to share a recent video featuring our retired founding Executive Director’s explanation of the importance of randomization in clinical trials:

Materials Available for Device-Focused Workshop in QbD Project

Posted on by Lorri Bingham

On January 29-30, 2014, CTTI’s QbD Project held a workshop focused on clinical trials that evaluate medical devices (diagnostic and therapeutic). The objectives for this workshop were similar to previous QbD Workshops:

  • To develop understanding of risk-based Quality by Design (QbD) for clinical trials, from general principles, real-world examples, and hypothetical case studies;
  • Gain confidence in the application of such concepts to clinical trials;
  • Identify obstacles to the adoption of this approach;
  • And identify opportunities for dissemination of these principles and practices to a broad array of stakeholders.

 

Executive Summary of the CTTI-Hosted Expert Meeting on Good Clinical Practices Now Available Online

Posted on by Lorri Bingham

GCP Training Expert Panel

On January 31, 2014, CTTI convened a diverse array of thought leaders from the clinical trials enterprise to discuss good clinical practice (GCP) training. The goal of this meeting was to seek consensus on the key elements of GCP training, as well as the frequency, format, and competency of training required to conduct clinical studies in the United States. We are now pleased to share the executive summary from this meeting online. For more information on this expert meeting, including the participant list and presentations, CLICK HERE.

This meeting is a part of CTTI’s ongoing GCP Training Project. For more information on this project, CLICK HERE.