On July 28 – 29, 2015, CTTI’s Data Monitoring Committee Project hosted an expert meeting. The objectives of this multi-stakeholder meeting were to:
The summary is now available online.
We are pleased to announce that CTTI’s HABP/VABP Trials Project will be presenting a poster at ICAAC/ICC 2015. In September, the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and the International Congress of Chemotherapy and Infection (ICC) will host this conference, intended for clinical microbiologists, infectious disease physicians, researchers, and pharmacists.
Session Details:
We look forward to connecting with colleagues at this event.
CTTI’s recommendations and implementation tools for advancing the use of central IRBs for multi-center clinical trials will be presented at the next webinar in the MDICx series. The featured speakers include Cynthia Hahn, Chief Operating Officer, The Feinstein Institute for Medical Research, and Soo Bang, Sr. Director, Global Alliances & Business Development, Celgene Corporation.
Webinar Details:
We look forward to this event and encourage the sharing of this invitation with colleagues involved in the clinical trial enterprise.
On August 20, CTTI will host a public webinar featuring 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 take part in this event.
The goal of MDIC’s PCBR was to establish a credible framework for defining patient preferences on the benefits and risks of new medical technologies that might be incorporated into the regulatory approval process. Board Member and Project Board Champion, Ross Jaffe will give an overview of this newly released report: “A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technologies.” The webinar will also include Kathryn O’Callaghan from FDA’s Centers for Devices and Radiological Health (CDRH), who will discuss the FDA’s new draft guidance, “Patient Preference Information- Submission, Review in PMAs, HDE Applications, and DeNovo Requests, and Inclusion in Device Labeling“, issued on May 13th.
Webinar Details:
We encourage you to forward this invitation to colleagues involved in the clinical trials enterprise.
On August, 21, 2015, the recommendations and Toolkit resulting from CTTI’s Quality by Design Project will be featured in an NIH Collaboratory Grand Rounds webinar. QbD Team Leaders Ann Meeker-O’Connell of Johnson & Johnson and Mark Behm of AstraZeneca will be presenting.
“This toolkit represents a compilation of documents, guidelines, forms, and videos that will help you put Quality by Design into operation within your organization. It’s been developed by professionals from across the entire spectrum of the clinical trials endeavor.”
– Mark Behm, AstraZeneca
Webinar Details:
We encourage you to share this invitation with colleagues involved in the clinical trials enterprise.
#InnovationThroughCollaboration
Since CTTI’s inception in 2007, we’ve published 33 peer-reviewed papers in our quest to identify and promote practices that will increase the quality and efficiency of clinical trials. Today, we’d like to highlight our top three most cited publications.*
#1) Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change
CITED 156 TIMES
Authors: Luce BR, Kramer JM, Goodman SN, Connor JT, Tunis S, Whicher D, Schwartz JS
Journal: Annals of Internal Medicine
Publication Date: August 4, 2009
This article addresses several fundamental limitations of traditional randomized clinical trials for meeting comparative effectiveness research (CER) objectives and offers 3 potentially transformational approaches to enhance their operational efficiency, analytical efficiency, and generalizability for CER.
#2) The Clinicaltrials.gov Results Database – Update and Key Issues
CITED 154 TIMES
Authors: Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC
Journal: The New England Journal of Medicine
Publication Date: March 3, 2011
This publication resulted from CTTI’s State of Clinical Trials project. The authors present an update on relevant policies, summarize the structure and contents of the results database, and show how ClinicalTrials.gov data can be used to gain insight into the state of clinical research.
#3) Characteristics of clinical trials registered in clinicaltrials.gov, 2007-2010
CITED 91 TIMES
Authors: Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A
Journal: JAMA
Publication Date: May 2, 2012
This publication resulted from CTTI’s State of Clinical Trials project. The authors examine fundamental characteristics of interventional clinical trials registered in the ClinicalTrials.gov database.
To view a complete list of CTTI’s Publications, CLICK HERE.
*Citation data source: web of science (August 3, 2015)
Advances in clinical trial design over the past decade have offered new and accelerated pathways for drug development. Despite this, the development of novel antibacterial therapies is lagging due to scientific and economic challenges. To address this critical unmet need, CTTI has hosted meetings to provide an opportunity for leading experts in clinical trial methodologies to discuss alternative approaches to design and analysis that may be useful for antibacterial drug development programs.
On November 19, 2014, CTTI, in collaboration the FDA’s Antibacterial Statistics Working Group, convened the second meeting of statistical and medical experts in the area of antibacterial drug development. The goals of this meeting were to:
We are pleased to share an Executive Summary of this meeting, in addition to the presentations and agenda. Click here to view all meeting materials.
*This meeting is part of CTTI’s Unmet Need in Antibiotic Development Project.
CTTI’s State of Clinical Trials Project set out to facilitate the analyses of data in ClinicalTrials.gov, by creating the database for Aggregate Analysis of ClincalTrials.gov (AACT), a restructured and reformatted relational database developed using publicly available and downloadable data from ClinicalTrials.gov. Since the original AACT was created in 2010, we’ve continued to regularly issue updated versions of the database.
The latest version of the AACT Database is now available on the CTTI website, along with the supporting documents. This dataset reflects data downloaded from ClinicalTrials.gov in March 2015. To assist users with interpretation of the data, high level and comprehensive data dictionaries and a points to consider document are also located on the CTTI website. Previous versions of AACT are available as well.
Since CTTI released the first AACT database five years ago, it has been utilized to answer many questions regarding the landscape of clinical trials. For a list of peer-reviewed publications that have assessed the state of trials within medical specialties, CLICK HERE.
On July 10, 2015, the NIH Collaboratory’s Grand Rounds Webinar Series featured the work of CTTI’s Central IRB Advancement Project. Co-team leader Cynthia Hahn reviewed the recently released recommendations for advancing the use of central IRBs for multicenter clinical trials.
We are now pleased to share the recording of this webinar:
This week, Clinical Trials published Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel. This publication is the result of CTTI’s Informed Consent Project and is based on the expert interviews conducted with stakeholders who have long-standing experience with the informed consent process. The goal of these interviews was to identify limitations within the current informed consent process and actionable recommendations for change. Three major themes emerged from these interviews, namely reform of the informed consent document, enhancing participant understanding of the clinical research, and modification of IRB review.
“The consensus recommendations from the interviewees provide a framework for meaningful change in the informed consent process. Although some proposed changes are feasible for rapid implementation, others such as substantive reform of the informed consent document may require change in federal regulations.”
-B. H. Lorrell, et al.
Figure 1. Enhancing research participant understanding of a clinical trial. Derived from authors’ analysis of results from 25 interview transcripts.
