Author: Lorri Bingham

CTTI Insights for Research Sites Featured at Upcoming SCRS Summit

Posted on by Lorri Bingham

SCRS Global Site Solutions SummitCTTI’s work will be featured in two presentations at the upcoming Society for Clinical Research Sites (SCRS) Global Site Solutions Summit on October 13-16, a conference aimed at fostering collaboration between industry and sites in clinical research.

CTTI Executive Director Pamela Tenaerts will be sharing insights on initiatives to assist sites as key stakeholders in studies and to improve overall collaboration in clinical research. Tenaerts will reinforce CTTI’s commitment to help sites be successful.

SCRS President Christine Pierre will present CTTI’s research on investigator turnover and its impact on-site resources and overall trial performance. Investigator turnover is a major inhibitor of site efficiency in trials, and Pierre will share ideas for better supporting sites in order to increase PI retention.

CTTI is proud to participate in this conference aimed at building strong partnerships between stakeholders.

 

SCRS 2016 Global Site Solutions Summit
Conference Location: Boca Raton, Florida

Presentation Topic: Investigator Turnover
Speaker: Christine Pierre
Date & Time: October 14, 2016, at 4:10 p.m. ET

Presentation Topic: Sites Matter: Industry Collaboration
Speaker: Pamela Tenaerts
Date & Time: October 14, 2016, at 5:30 p.m. ET

 

 

Unmet Need in Antibiotic Development: Expert Meeting Materials Now Available

Posted on by Lorri Bingham

On March 1, 2016, CTTI hosted a multi-stakeholder expert meeting for its Unmet Need in Antibiotic Development Project. This project is investigating perceptions of antibacterial drugs developed using accelerated pathways. Non-traditional development pathways can expedite the availability of much-needed new antibacterial therapies, but there is a tradeoff in risk and uncertainty.

At the expert meeting, results were presented from focus groups and interviews conducted to elicit opinions from patients, healthy persons, caregivers, and physicians on the use of antibacterial drugs developed using streamlined approaches. Meeting attendees, which included representatives from academia and pharmaceutical companies, patient advocates, regulators, and other stakeholders, discussed ways to improve labeling, risk communication, and public understanding in the context of streamlined antibacterial drug development approaches. This input informed interpretation of the findings and project next steps. We are now pleased to share the meeting materials, which may inform others working to address the serious public health issue of antibacterial resistance.

CLICK HERE to access the meeting summary, slides, agenda, and other materials.

This project is part of CTTI’s Antibacterial Drug Development Program.

Recording Now Available: Webinar on Improving Clinical Trial Recruitment

Posted on by Lorri Bingham

On May 19, 2016, CTTI hosted a webinar on moving recruitment planning upstream to reduce barriers to clinical trial participation. This webinar was the official unveiling of CTTI’s new recommendations and tools resulting from the Recruitment Project. We are now pleased to share the recording from this webinar, in which you can learn more about:

  • A holistic approach that integrates strategic recruitment planning throughout the entire clinical trial process, beginning with study design and development
  • Ways to identify and engage all relevant stakeholders throughout recruitment planning to prevent downstream recruitment challenges
  • Recommendations for trial feasibility, site selection, and developing strategic recruitment communication plans
  • New tools available to aid in strategic recruitment planning

The slides and responses from the webinar’s Q&A session are also available for download.

We encourage you to share these resources with your colleagues in the clinical trials enterprise.

To view recordings of other CTTI webinars, CLICK HERE.

New NIH Policy Aligns With CTTI’s Work to Increase Adoption of Central IRBs

Posted on by Lorri Bingham

The NIH has issued a final policy requiring the use of a single institutional review board (IRB) for multi-center NIH-funded clinical trials. The policy will take effect May 25, 2017.

Since 2010, CTTI has been working to address barriers to the adoption of central IRBs for multi-center clinical trials through its Central IRB and subsequent Central IRB Advancement projects. The draft NIH policy released in 2014 referenced CTTI’s recommendations, and the final policy reflects CTTI’s shared goal to increase the efficiency of clinical trials through the use of central IRBs.

With the NIH mandate now finalized, CTTI’s tools are available to help with implementation. These include the following:

  • a template IRB authorization agreement
  • an evaluation checklist with considerations for 1) assessing an institution’s readiness for central IRB adoption, 2) selecting a central IRB, and 3) deciding when a central IRB should work with a specific institution
  • a considerations document to address the often blurred distinctions between responsibilities for ethics review and other institutional obligations

According to the new policy, “while the NIH anticipates that there will be challenges associated with implementation, we expect these to be short-lived. Once the transition to the new way of operating is made, the benefits of widespread use of [single IRBs] will outweigh any costs and, ultimately, reduce burdens to the research process.”

CTTI applauds this important progress for the clinical trials enterprise.

 

Updated AACT Database Now Available & Ripe for Mining

Posted on by Lorri Bingham

The latest version of the AACT Database is now available on the CTTI website, along with the supporting documents.

CTTI’s State of Clinical Trials Project updates the Aggregate Analysis of ClincalTrials.gov (AACT) database twice annually. AACT is a restructured and reformatted relational database developed using publicly available and downloadable data from ClinicalTrials.gov. Since its initial release, the AACT database has been used to answer many questions regarding the landscape of clinical trials.

This latest dataset reflects data downloaded from ClinicalTrials.gov on March 27, 2016. To assist users with the interpretation of the data, a comprehensive data dictionary and points to consider document are also available on the CTTI website. Previous versions of AACT are posted as well.

Recording Now Available: Webinar on IND Safety Reporting

Posted on by Lorri Bingham

Are you confused about how best to comply with the FDA final rule on IND safety reporting? Would you like to hear more about how to handle common, yet challenging, safety reporting situations?

We invite you to view the recording from CTTI’s webinar, which explored challenging safety reporting scenarios using case studies. Presenters from CTTI’s IND Safety Advancement Project Team included representatives from CTTI, FDA, and industry.

To view recommendations and publications from CTTI’s IND Safety Advancement Project, CLICK HERE.

 

CTTI Program to Increase Adoption of Mobile Clinical Trials

Posted on by Lorri Bingham

MCT ProgramCTTI is excited to introduce its Mobile Clinical Trials (MCT) Program, which will identify and address challenges to the use of mobile technologies to facilitate clinical trials for regulatory submissions. These technologies have the potential to increase the quality and efficiency of clinical trials by allowing remote participation and monitoring, creating opportunities to develop novel endpoints, and streamlining data collection.

The integration of mobile technologies into clinical trials is in the early phases. Through the MCT Program, CTTI will help create a pathway to drive this promising transformation.

CTTI’s MCT Program includes four projects addressing specific challenges. Within each of these areas, CTTI’s multi-stakeholder teams have begun gathering evidence to develop tools and best practices that can be deployed throughout the clinical trials enterprise to promote widespread integration of mobile technologies.

 

Learn more about the CTTI MCT projects:

  1. Legal and Regulatory Issues
  2. Novel Endpoints
  3. Stakeholder Perceptions
  4. Use of Mobile Devices

CTTI will present on this new initiative at the Mobile in Clinical Trials Conference on Monday, September 19, 2016.

Recording Now Available: Webinar on Best Practices for DMCs From CTTI’s Latest Recommendations

Posted on by Lorri Bingham

On June 16, 2016, CTTI hosted a webinar on its new recommendations on best practices for the use of Data Monitoring Committees (DMCs). This webinar provided an opportunity to learn about ways to enhance the functioning of DMCs through member training, clear roles and responsibilities, charter development, communication practices, and more. The recommendations resulted from CTTI’s DMCs Project.

We encourage you to share this recording with your colleagues in the clinical trials enterprise.

 

Upcoming Webinar: Quality by Design for Clinical Trials

Posted on by Lorri Bingham

On August 10, CTTI will present Clinical Trial Quality by Design: Factors Critical to Quality, a joint webinar with the Medical Device Innovation Consortium (MDIC). The presentation will feature strategies for designing quality, efficient clinical trials from CTTI’s Quality by Design (QbD) Project and MDIC’s Clinical Trial Design Working Group. MDIC was able to build upon CTTI’s QbD recommendations and address special considerations for the design of medical device clinical trials. This work demonstrates a strong synergy between two multi-stakeholder public-private partnerships dedicated to improving clinical trials.

We invite you to join this free, public webinar to learn more about quality design for clinical trials, including medical device trials.

CLICK HERE to register.

Topic: Clinical Trial Quality by Design: Factors Critical to Quality

Date & Time: Wednesday, August 10, 2016 at 1 p.m. ET

Speakers:

  • Susan Alpert, MDIC Clinical Trial Design Working Group Chair
  • Ann Meeker-O’Connell, CTTI QbD Project Team

Upcoming Webinar: Global Expert Panel on Antibacterial Drug Development

Posted on by Lorri Bingham

CTTI invites you to participate in a free, public webinar to learn about collaborative and innovative approaches to address the international public health crisis of antibacterial resistance. A panel of preeminent thought leaders will present these efforts, which appear in a recently published peer-reviewed supplement in the journal Clinical Infectious Diseases (CID).

The webinar will include the presentation of two new sets of CTTI recommendations designed to advance clinical trials for an important and particularly challenging area of antibacterial drug development: hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

This work is part of CTTI’s Antibacterial Drug Development (ABDD) Program, which includes a portfolio of projects tackling specific issues intended to improve clinical trials evaluating potential new antibacterial drugs.

We encourage you to share this invitation with others who may be interested in learning more about CTTI’s ABDD Program and the HABP/VABP Recommendations.

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

Date & Time: Wednesday, August 24, 2016, from 12:00 p.m. – 1:00 p.m. EDT (New York, GMT-04:00)

Speakers:

  • 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 Login: CLICK HERE to enter the meeting.

Meeting Number: 730 531 918

Meeting Password: ctti

After you connect to the website, please follow step-by-step instructions for connecting to the audio.

 

If you prefer to connect to audio only, you can join by phone at:

1-855-244-8681 Call-in toll-free number (US/Canada)  

1-650-479-3207 Call-in toll number (US/Canada)