Recently Released: Expert Meeting Summary on IND Safety

On July 21 – 22, 2015, CTTI’s IND Safety Advancement Project hosted an expert meeting. The objectives of this multi-stakeholder meeting were to:

  • Present findings and conclusions from the project evidence gathering activities
  • Discuss opportunities for improving the efficiency and value of the expedited IND safety reporting process
  • Understand opportunities for educating stakeholders on expedited IND safety reporting best practices

The summary is now available online.

Latest Edition of Clinical Trials Tackles Ethical and Regulatory Issues

special issue on ethical and regulatory issues in pragmatic clinical trials has been published in the journal Clinical Trials. The effort was sponsored by the NIH Collaboratory, with additional support from the Patient-Centered Outcomes Research Institute (PCORI). As NIH Collaboratory pragmatic clinical trials were implemented, it became clear that ethical and regulatory complexities were some of the biggest challenges in conducting pragmatic clinical research. The NIH Collaboratory engaged groups of stakeholders, including researchers, patient advocates, bioethicists, and regulatory experts, to address a set of 11 ethical and regulatory issues. Each article in the special issue describes a particular ethical or regulatory challenge faced by pragmatic clinical trials and offers recommendations for how to protect the rights and welfare of research participants while enabling large-scale research that delivers critically needed evidence to healthcare decision-makers. The topics include alteration of informed consent, privacy, gatekeepers, vulnerable populations, and defining minimal risk research. An introduction was written by Robert M. Califf, MD, and Jeremy Sugarman, MD, MPH, who also served as editors of the issue.

New Publication: CTTI Presents Stakeholder Survey Results on Barriers and Solutions to Clinical Trial Recruitment

This week, Applied Clinical Trials published Barriers to Clinical Trial Recruitment and Possible Solutions: A Stakeholder Survey. This publication is the result of the CTTI Recruitment Project Team’s efforts to gain a deeper understanding of stakeholders’ perceived barriers to recruitment across the clinical research enterprise. Several stakeholder groups, including clinical trial sponsors (industry, federal, and academic), research sites (investigators, coordinators, and executive-level staff), and patient advocacy organizations, were polled to gather information on approaches that will improve patient recruitment and enable trials to meet recruitment goals. The significant barrier most often cited by respondents was that of finding or identifying patients who meet eligibility criteria. A solution to this barrier that was proposed by a respondent was to broaden the eligibility requirements to enroll individuals more representative of the actual population. To improve recruitment efforts, respondents felt that medical record and hospital-based registry or database review were effective and often successfully employed. Additionally, building relationships and establishing referral programs with trusted clinicians were considered crucial to enhance recruitment. Overall, the majority of respondents had a positive outlook on the potential to increase recruitment rates over the next decade.

 

“The positive outlook on increasing clinical trial recruitment over the next 5 to 10 years among respondents is encouraging of the potential for progress to be made. It is apparent that a comprehensive recruitment strategy, rather than a single tool or solution, will be required to address the range of significant recruitment barriers identified.” – E. Mahon, et al.

 

To read the publication, click here.

Recently Released: Expert Meeting Summary on DMC’s

On July 28 – 29, 2015, CTTI’s Data Monitoring Committee Project hosted an expert meeting. The objectives of this multi-stakeholder meeting were to:

  • Present findings and conclusions from the project survey and focus groups
  • Share and solicit feedback on proposed Data Monitoring Committees (DMCs) recommendations

The summary is now available online.

CTTI Presents on Cost Drivers of HABP/VABP Phase Three Clinical Trials at ICAAC/ICC 2015

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:

  • Title: Cost Drivers of Hospital Acquired Bacterial Pneumonia and Ventilator Associated Bacterial Pneumonia (HABP/VABP) Phase Three Clinical Trials
  • Date: September 18, 2015
  • Time: 12:00 – 2:00 PM
  • Presenter: Stella Stergiopoulos

We look forward to connecting with colleagues at this event.

CTTI’s Recommendations & Implementation Tools for Advancing the Use of Central IRBs to be Featured in Upcoming MDICx Webinar

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:

  • Date: Wednesday, August 12th
  • Time: 12:00 p.m. – 1:00 p.m. ET
  • REGISTER HERE

We look forward to this event and encourage the sharing of this invitation with colleagues involved in the clinical trial enterprise.

CTTI Webinar Invitation: MDIC’s Patient Centered Benefit-Risk Framework

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:

  • Title: Integrating Patient Preferences into the Regulatory Review of Medical Devices
  • Date/Time: August 20, 12:00-1:00 p.m. EST
  • WebEx LinkClick here (Meeting Number: 738 915 200 and Meeting Password: ctti)

We encourage you to forward this invitation to colleagues involved in the clinical trials enterprise.

CTTI’s QbD Recommendations & Toolkit to be Featured in Upcoming NIH Collaboratory Grand Rounds

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

Don’t Miss CTTI’s 3 Most Cited Publications

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)

Executive Summary Available for CTTI’s Statistical Issues in Antibiotic Development Think Tank II

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:

  • Provide an update on the current status of statistical methodologies for the design and analysis of antibacterial drugs
  • Discuss ongoing challenges in the development and adoption of innovative methods
  • Generate strategies to propel antibacterial drug development forward

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.