CTTI News

CTTI Now Accepting Applications for Individual Patient/Caregiver Representatives

Posted on by Lorri Bingham

Are you a patient or caregiver who is passionate about improving the clinical trial process? Do you have an understanding of the clinical trial system and related regulations? Would you like to be involved with an organization that brings together the diverse stakeholders involved in the clinical trials enterprise to bring about positive change?

If you answered yes to these questions, you may be a candidate for the position of Patient/Caregiver Representative on the CTTI Steering Committee.

CTTI is now accepting applications, through December 10, 2014, for two individual Patient/Caregiver Representatives. Reps will each serve a three-year term, providing a patient voice in the activities and discussions of the CTTI Steering Committee and on project teams.

For more information about the application process, click here.

“Ultimately the remedy for our ailing clinical research system depends on the collective effort of all constituents involved in the clinical trials process; CTTI provides an optimal venue for this collaboration.”
-Pamela Tenaerts, Executive Director, Clinical Trials Transformation Initiative

CTTI Among the Spotlighted Consortia Focused on Drug Development Challenges

Posted on by Lorri Bingham

The latest issue of Nature Reviews Drug Discovery highlights several consortia that have resulted from the FDA’s Critical Path Initiative, launched nearly a decade ago. CTTI is among these initiatives and was featured in the article, The Clinical Trials Transformation Initiative: innovation through collaboration.

This publication explains the crisis in the clinical trials enterprise and CTTI’s unique role in developing actionable solutions. Several CTTI project are highlighted, including Quality by Design, Central IRB, and Investigational New Drug Safety Reporting. For each of these projects, the authors identify the issue at hand and go on to explain CTTI’s efforts to implement recommendations, noting both the difficulties and imperative of creating cultural and organizational change. The authors also comment on the ability of CTTI’s evidence-based work to inform policy and practices in the interest of public health.

“By creating an environment of trust, we enable the stakeholders — representing all sectors of the enterprise — to think about practical solutions to the identified problems and to develop strategies to effect change.”
– Pamela Tenaerts, Leanne Madre, Patrick Archdeacon, and Robert Califf

CTTI Speaks to Patient-Centeredness & Innovation in Clinical Trials at Upcoming Partnering for Cures Conference

Posted on by Lorri Bingham

On November 16-18, 2014, FasterCures will host their 6th Annual Partnering for Cures conference in New York City. This meeting will provide a platform to bring “together leaders from all sectors in medical research with the express purpose of making collaboration happen – collaborations that must happen if we are to speed up the time it takes to turn discoveries into treatments and cures” (partneringforcures.org). If you are attending this conference, we encourage you to engage with CTTI at one of the following events.

CTTI AT PARTNERING FOR CURES 2014:

Event Type: Breakfast Affinity Roundtable
Topic: Rethinking clinical trials
Date & Time: Monday, November 17, 2014 at 7:00 – 8:00 AM
The goal of the Breakfast Affinity Roundtables is to jumpstart networking by organizing informal gatherings of conference attendees who have similar interests. CTTI’s Director of Stakeholder Engagement, Bray Patrick-Lake will be leading the informal discussion focused on innovative approaches to clinical trials.

Event Type: Plenary Panel
Topic: Putting the patients in ‘patient-centeredness’
Date & Time: Tuesday, November 18, 2014 from 3:30 – 4:30 PM
Bray Patrick-Lake will also be speaking at the Partnering for Cures Session that focuses on concrete efforts for patients to be at the center of the medical research system.

 

To view the conference agenda, along with session descriptions, click here.

If you are on Twitter, we invite you to join the conversation:

Results of CTTI’s GCP Training Project Featured at NCATS Meeting

Posted on by Lorri Bingham

The first of two working meetings for the Enhancing Clinical Research Professionals’ Training and Qualifications project took place earlier this week in Chicago, IL. At this national conference, CTTI’s Executive Director Pamela Tenaerts presented CTTI Findings and Recommendations for GCP Training, based on our GCP Training Project.

The primary goal of this first meeting [was] to achieve consensus in identifying a standardized training platform in Good Clinical Practice (GCP) and the necessary means to disseminate it across all consortium sites. (ctsacentral.org)

The Enhancing Clinical Research Professionals’ Training and Qualifications project is supported by a National Center for Advancing Translational Sciences (NCATS) supplement award and serves the Clinical and Translational Science Award (CTSA) consortium.

Ethicist Dr. Felix Gyi Remembered for his Commitment to Human Subjects Protection

Posted on by Lorri Bingham

We are saddened by the unexpected passing of Dr. Felix A. Khin-Maung-Gyi, executive chairman and founder of Chesapeake Research Review LLC.

Dr. Gyi’s contributions to CTTI and the greater clinical trials community will not be forgotten. As an ethicist specializing in clinical research, he was both well respected and passionate about human subjects protection. In addition to establishing Chesapeake IRB, he also served as a member of CTTI’s Steering Committee and was instrumental in spearheading CTTI’s Central IRB Project as a team lead.

The CTTI staff send our condolences to Dr. Gyi’s family, friends and colleagues.

“Felix Gyi will be remembered at CTTI for his enthusiastic efforts to catalyze our first IRB Project. We will all miss his passion and contribution to the clinical trials community.”

-Pamela Tenaerts, CTTI’s Executive Director

CTTI Highlights Multi-stakeholder Perspectives in Drug Development at Upcoming Clinical Investigator Course

Posted on by Lorri Bingham

On November 4 – 6, 2014 the FDA’s Office of Medical Policy and the Duke School of Medicine will co-sponsor the Sixth Annual Clinical Investigator’s course in College Park, MD.

This extensive 3-day course focuses on nonclinical, early clinical, and phase 3 studies; issues in the design and analysis of trials; safety and ethical considerations; and FDA’s regulatory requirements related to the performance and evaluation of clinical studies. (fda.gov)

During this event, CTTI will be represented in the Session 6 Roundtable titled The Clinical Investigator’s Role in Drug Development: a multi-stakeholder perspective at 2:15 pm on Thursday, November 6. To view the agenda for the entire program, click here.

We look forward to connecting with our colleagues at this event.

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.