CTTI News

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.

 

CTTI Welcomes New Members ACI Clinical and Greenleaf Health

Posted on by Lorri Bingham

CTTI would like to welcome our two newest members, ACI Clinical and Greenleaf Health.

ACI Clinical specializes in managing and facilitating Endpoint Adjudication Committees and Data Monitoring Committees to enhance trial integrity and prepare data. Jonathan Seltzer will be representing ACI Clinical on CTTI’s Steering Committee. Greenleaf Health focuses on strategic regulatory consultation within the healthcare sector and will be represented by Rachel Sherman.

At CTTI, we pursue innovation through collaboration. By engaging all stakeholders in the clinical trial enterprise as equal partners, we analyze existing research impediments and recommend consensus-driven, actionable solutions that will lead to a more sustainable and effective clinical trial system. We look forward to the perspectives that ACI Clinical and Greenleaf Health promise to bring to CTTI’s collaborative environment.

New Publication Addresses Rising Antibiotic Resistance and Clinical Trial Design

Posted on by Lorri Bingham

On June 23, 2014, an article titled Hierarchical nested trial design (HNTD) for demonstrating treatment efficacy of new antibacterial drugs in patient populations with emerging bacterial resistance was published online in Statistics in Medicine. This article describes a novel clinical trial model to determine efficacy of antibacterial drugs in trial populations with emerging antibiotic-resistant bacterial infections.

Authors Mohammad Hugue and colleagues cite the CTTI-hosted Statistical Issues Think Tank where they and other experts were able to exchange ideas that in part lead to the development of the model.

For more information on this meeting, including the list of attendees, agenda, presentations, and background summary, CLICK HERE.

Consortium Approaches at the 2014 BIO International Convention

Posted on by Lorri Bingham

This week, the 2014 BIO International Convention will be held in San Diego, California. On Thursday, June 26, CTTI’s Director of Stakeholder Engagement Bray Patrick-Lake will be speaking in a breakout session, titled A Consortium Approach to Enhancing Productivity in Clinical Trials, along with Steve Cummings of UCSF, Dalvir Gill of TransCelerate Biopharma, John Orloff of Merck Serono, and moderator Gergory Keenan of AstraZeneca and MedIummune.

This panel will explore work being done with the pharmaceutical industry to speed up and improve the end-to-end clinical trials process and emerging issues where a consortium approach can help the pharmaceutical industry be more productive. (myBio.com)

If you are planning to attend the 2014 BIO International Convention, we look forward to seeing you at this session.

Date: Thursday June 26, 2014

Time: 1:00 PM – 2:00 PM PST

Location: Room 31A

Session ID: 2436

If you are on Twitter, please feel free to connect with us on that platform, too:

@CTTI_Trials

@BrayPatrickLake

#BIO2014

CTTI’s #DIA2014 Posters Available Online

Posted on by Lorri Bingham

On June 15-19, the DIA hosted their 50th Annual Meeting (also known as #DIA2014) in San Diego, CA. Several CTTI members and staff attended the conference, and were involved with panels, workshops and poster presentations. We are now pleased to share the posters from this event on our website:

  1. A Collaboration to Facilitate the Development of Antibacterial Agents for Unmet Need: Streamlining Clinical Trial Protocols
    Abstract Summary: This collaboration includes the participation of a multi-disciplinary working group led by CTTI. Several meetings and workshops were held to gain a wider understanding of issues, several solutions using a Quality by Design approach were proposed.
    Presenter: Gary Noel, MD, Senior Director for Janssen Research and Development
  2. Good Clinical Practice (GCP) Training: Identifying Key Elements and Strategies for Increasing Training Efficiency
    Abstract Summary: CTTI convened a multidisciplinary working group involving partners from academia, industry, and government to develop recommendations for streamlining current GCP training efforts.
    Presenter: Jonathan Seltzer, MD, MA, MBA, FACC, President and CEO for Applied Clinical Intelligence, LLC

We would like to thank our colleagues in attendance at #DIA2014 who contributed to this successful conference, and we look forward to seeing you at #DIA2015.

Invent the Future with CTTI at DIA 2014 50th Annual Meeting

Posted on by Lorri Bingham

On June 15-19, the DIA is hosting their 50th Annual Meeting in San Diego, CA. The tagline for this year’s event, Celebrate the Past – Invent the Future, resonates closely with one of CTTI’s own strategic approaches: helping to shape the clinical trials enterprise of the future.

During this week of forward-thinking discussions, we look forward to connecting with many of you. Several CTTI representatives will be presenting, and CTTI will also host a pre-conference tutorial. Specifically, we look forward to sharing our work on quality by design, patient recruitment, antibacterial drug development, and good clinical practice. Below is a schedule of opportunities to hear more about these topics at the conference.

Sunday June 15, 2014

9:00 AM – 5:00 PM – Quality by Design, from Theory to Practice

  • Event Information: Pre-Conference Tutorial TUT44 (*Advanced Registration Required)
  • Presenters: Ann Meeker-O’Connell, Jean Mulinde, John Alexander
Tuesday June 17, 2014

7:15 AM – 4:00 PM – A Collaboration to Facilitate the Development of Antibacterial Agents for Unmet Need: Streamlining Clinical Trial Protocols

  • Event Information: Poster – W30 located in the Sails Pavilion
  • Presenter: Charles Knirsch

8:00 AM – 9:30 AM – Updated Strategies for Effective Recruitment of Patients in Clinical Trials

  • Event Information: Panelist Session #201 located in Room 1B
  • Presenters: Elizabeth Mahon (Chairperson); Margo Michaels, Jonca Bull (Panelists)

1:30 PM – 3:00 PM – Collaborating to Streamline Drug Development: Case Studies of What Works (and What Doesn’t)

  • Event Information: Panelist Session #259 located in Room 2
  • Presenters: Douglas Peddicord (Chairperson); Dalvir Gill, Christine Pierre, Pamela Tenaerts, Ann Meeker-O’Connell (Panelists)
Wednesday June 18, 2014

7:15 AM – 4:00 PM – Good Clinical Practice (GCP) Training: Identifying Key Elements and Strategies for Increasing Training Efficiency

  • Event Information: Poster – T03 located in the Sails Pavilion
  • Presenter: Jonathan Seltzer

If you are on Twitter, please feel free to connect with us on that platform, too:

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.