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Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials

CTTI Project: Developing Novel Endpoints

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Webinar Presenters:

Presenters:

  • Martin Landray, PhD, FRCP, University of Oxford
  • Marc Walton, Johnson and Johnson

Panelists:

  • Leonard Sacks, FDA
  • Lauren Bataille, The Michael J Fox Foundation
  • Wendy Snyder, Amgen
  • Rob Wilson, ActiGraph

Webinar Objective:

New CTTI Recommendations and Tools Equip Stakeholders to Integrate Mobile Technology into Clinical Trials

Mobile technologies hold enormous promise for clinical research, but uncertainty about how to use the data captured by these devices has slowed progress. In this webinar, CTTI unveils recommendations and tools that aim to change this by providing a pathway for using information gathered from mobile technologies to accelerate the development and evaluation of urgently needed therapies.

Medical Device Innovation Consortium’s (MDIC) Patient Centered Benefit-Risk (PCBR) Framework

CTTI Project: Patient Group Engagement

Webinar Presenters:

  • Ross Jaffe, Managing Director, Versant Ventures; Director, National Venture Capital Association; Board Champion, MDIC
  • Kathryn O'Callaghan, Associate Center Director for Science & Strategic Partnerships, FDA CDRH

*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

This webinar features the Medical Device Innovation Consortium (MDIC) and their recently released Patient Centered Benefit-Risk Assessment (PCBR). CTTI’s Director of Stakeholder Engagement, Bray Patrick-Lake, participated in the development of the PCBR framework and we are pleased to share the recording of this event.

How Improved Pregnancy Testing Planning Can Lead to Safer, More Efficient Clinical Trials

CTTI Project: Pregnancy Testing

Webinar Presenters:

  • Claire Jurkowski, MD, former medical director, Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb (Retired)
  • Jessica Morse, MD, MPH, assistant professor, University of North Carolina School of Medicine
  • Evan Myers, MD, MPH, professor, Duke University Medical Center

Webinar Objective:

Pregnancy testing is necessary in clinical trials if there is a possibility of pregnancy in the study population and embryo/fetal exposure to the study treatment poses a known or unknown risk.  In this webinar, CTTI unveils new recommendations and an online tool to help research sponsors, investigators, and institutional review boards develop and review pregnancy testing plans, to conduct safer, more efficient clinical trials.

Webinar Agenda:

The webinar will include:

  • Steps involved in proactive planning for pregnancy testing before the start of a clinical trial
  • A new online application to help assess the balance of benefits and burdens of specific pregnancy testing plans
  • Ways study coordinators can improve communication so women receive clear, comprehensive information before joining a clinical trial
  • How these new recommendations promote the safe inclusion of women in clinical trials

CTTI Presents Recommendations for Strengthening the Investigator Site Community

CTTI Project: Investigator Community

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Webinar Presenters:

Presenters:

  • Christine Pierre (Society for Clinical Research Sites)
  • Matthew Roe (Duke Clinical Research Institute)
Panel members sharing their perspectives on these recommendations include:
  • David Ciavarella (C.R. Bard)
  • Robin Douglas (QuintilesIMS)
  • Terri Hinkley (Academy of Medical-Surgical Nurses)
  • Kaitlin Malone (Amgen)

Webinar Objective:

Attendees will learn how:
  • Workload, reporting burdens, time allocation challenges, and financial issues contribute to high rates of investigator turnover;
  • Investigators and study staff can benefit from improvements to research infrastructure and training and educational opportunities;
  • All stakeholders can contribute to optimizing trial conduct and to developing more efficient and transparent approaches to budgeting and contracting; and
  • Investigators can connect with opportunities to remain engaged in clinical research.

*CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. If you use any of the slides from this presentation, please let us know, credit CTTI, and make it clear that you are not presenting on behalf of CTTI.

Accelerating Evidence Generation – Resources for Implementing a QbD Approach to Clinical Trials

CTTI Project: Quality by Design

 

Webinar Presenters:

  • Greg Pennock, EMD Serono
  • David Rodin, Amici Clinical Research
  • Ansalan Stewart, FDA
  • Karlin Schroeder, Parkinson’s Foundation
  • Steve Young, CluePoints

Webinar Resources:

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Resources:

 

Antibacterial Drug Development in a Time of Great Need: Global Expert Panel

CTTI Project: Streamlining HABP/VABP Trials

Webinar Presenters:

  • Edward Cox, MD, MPH, U.S. Food and Drug Administration
  • Vance G. Fowler Jr, MD, MHS, Duke University
  • Bruno François, MD, University Hospital of Limoges, France
  • Hasan S. Jafri, MD, MedImmune
  • John H. Powers III, MD, George Washington University School of Medicine
  • John H. Rex, MD, AstraZeneca Pharmaceuticals
  • Pamela Tenaerts, MD, MBA, Clinical Trials Transformation Initiative

Webinar Objective:

On August 24, 2016, CTTI hosted a webinar on innovative approaches to transforming antibacterial drug development as recently featured in a Clinical Infectious Diseases (CID) supplement. The presentation highlighted the important role public-private partnerships play in advancing the field of antibacterial drug development and included an inside look at CTTI’s two new sets of recommendations for streamlining HABP/VABP trials. Thought leaders from CTTI, FDA, industry, and academia spoke, reflecting on the significance of this new body of work.

We are now pleased to share the webinar recording, in which you can hear more about:

  • Use of an evidence-based approach to characterize the challenges of studying new antibacterial drugs
  • Actionable solutions to these challenges developed from collaborations between multiple stakeholders
  • Ongoing work to determine the promise and potential implications of an early enrollment strategy for HABP/VABP trials

A Viewpoint on the Current State of Clinical Trials on the Path to Transformation from Dr. Robert Califf

CTTI Project: State of Clinical Trials

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Webinar Presenter:

Dr. Califf, who served as an original co-chair of CTTI and was instrumental in its creation, is a prominent cardiologist and clinical researcher whose career as a physician, teacher, researcher, and regulator spans more than three decades. Dr. Califf has provided leadership for numerous high-impact clinical trials and has been at the forefront of innovation in clinical research methods.

Webinar Information:

During this webinar, Dr. Robert Califf, former Commissioner of the US Food and Drug Administration (FDA) and the Fortin Professor of Cardiology at the Duke University School of Medicine, examined the current state of the clinical trials enterprise. Specifically, he addressed recent developments that have major implications for the clinical research enterprise in the United States, including the opportunities enabled by growing access to digital sources of data, the increasing importance of patient-reported outcomes, and the power of patient engagement in reshaping approaches to clinical research. As the recent head of FDA, Dr. Califf was directly involved in cross-agency efforts to modernize the national system for conducting clinical research by articulating a large, flexible, and widely shared approach to evidence generation (known as “EvGen”) that could leverage rapidly expanding sources of digital health data to produce high-quality, actionable information for patients and healthcare providers.

A particularly important aspect of these “EvGen” efforts hinges on effectively engaging patients and their advocates as partners in research, particularly as digital technologies and patient-reported outcomes data present new potential for the rapid and seamless acquisition of health data that is truly representative of broad and diverse populations. Ultimately, it is hoped that this new national research infrastructure will enable more rapid, representative, affordable, and generalizable clinical trials that can provide the high-quality evidence to enable a true learning health system. Many of these activities draw upon insights that were developed through pioneering investigations sponsored by CTTI, whose efforts will continue to shape national approaches to the creation and implementation medical knowledge.