Author: Lorri Bingham

CTTI Welcomes New Members Alexion & PhRMA

Posted on by Lorri Bingham

CTTI would like to welcome our newest members, Alexion Pharmaceuticals, Inc. and Pharmaceutical Research and Manufacturers of America (PhRMA).

Alexion Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and delivering therapies for patients with rare diseases. Alexion’s Vice President of Research and Development Quality, Coleen Glessner, will represent this organization on CTTI’s Steering Committee.

PhRMA is a non-profit membership association that represents the country’s leading pharmaceutical research and biotechnology companies. PhRMA’s Senior Director of Science and Regulatory Advocacy, Jocelyn Ulrich, will represent this organization on CTTI’s Steering Committee.

We are pleased to have these two new voices involved with CTTI’s work. CTTI actively engages all stakeholders equally to collaboratively improve the quality and efficiency of the clinical trials enterprise. For more information about the diverse representation of CTTI’s membership, click here.

Focus on the Process: CTTI Recommendations for Improved Informed Consent

Posted on by Lorri Bingham

NEW recommendations on Informed Consent

CTTI recommends a new model for the informed consent process that places the focus back where it should be: on the participant. The consent process should be an interactive, ongoing conversation between the participant and the research investigator or staff. “Patients who really understand what they are agreeing to when they sign an informed consent document are much more likely to adhere to trial requirements and be retained for the entire timeframe of the trial,” notes patient advocate, Jane Perlmutter. “Thus, not only is excellent consenting better for patients, it will also lead to more efficient and less costly trials.”

At a CTTI-hosted webinar on November 19, 2015, sponsors will hear suggestions and learn about tools to help them restructure the informed consent process and document to be more participant-friendly while retaining key information. The webinar will also explore the benefits of e-consent and how appropriate and thorough research staff training can improve the overall process for everyone involved.

The need for this new direction is recognized. “The Association of Clinical Research Professionals (ACRP) supports the recommendations put forth by our partners in the Clinical Trials Transformation Initiative,” says Jim Kremidas, ACRP Executive Director. “We are confident these recommendations will result in a more efficient and higher quality informed consent process conducted by clinical research professionals. A clear understanding of the risks and expectations clinical trial participants face will enhance their experience and drive better quality research.”

You’re Invited! CTTI Recommendations for an Improved Informed Consent Process to be Unveiled in November 19 Webinar

Posted on by Lorri Bingham

Join CTTI on November 19, 2015, as they host a webinar to present a new model of the informed consent process that places the focus back where it should be: the participant. This webinar will be the official unveiling of CTTI’s recommendations resulting from the Informed Consent Project and it is open to the public. We encourage you to share this invitation with your colleagues in the clinical trials enterprise.

Webinar Title: Public Unveiling of CTTI’s Informed Consent Project Recommendations

Date & Time: Thursday, November 19, 2015 from 12:00 – 1:00 p.m. EST

Speakers:

  • Jennifer Lentz, Global Informed Consent Process Owner, US CMS Coordinator, Global Clinical Operations, Eli Lilly and Company
  • Michele Kennett, Assistant Vice Chancellor for Research, Director of Human Research Protections, Director of MU Institutional Review Board, University of Missouri

Webinar Login:

  • CLICK HERE to enter meeting.
  • Meeting Number: 732 884 847
  • 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)

Latest CTTI Publication Documents Variation in Practices & Perceptions around Patient Engagement for Different

Posted on by Lorri Bingham

On October 14, 2015, PLoS ONE published Patient Engagement Practices in Clinical Research among Patient Groups, Industry, and Academia in the United States: A Survey. Written by members of CTTI’s Patient Groups & Clinical Trials Project, the objective of this publication was, “to gain a better understanding of attitudes and practices for engaging patient groups so that actionable recommendations may be developed.” After analyzing data from 179 survey respondents, significant differences were detected between “stakeholder groups in perceptions of the value of patient group engagement with academia and industry around clinical trials- finding that may represent a significant barrier to engagement that was not identified by the individual stakeholder groups independently.”

In addition to this publication, this CTTI project also developed Official Recommendations on Effective Engagement with Patient Groups around Clinical Trials.

We are pleased to share these free resources, and encourage you to share them with friends and colleagues active in the clinical trials enterprise.

If you are active on Twitter, you can participate in this ongoing conversation with #PGCT.

WEBINAR NOW AVAILABLE: CTTI Recommendations for Effective Engagement with Patient Groups Around Clinical Trials

Posted on by Lorri Bingham

Last week, team members from CTTI’s Patient Groups & Clinical Trials Project presented the official recommendations on effective engagement with patient groups around clinical trials in a public webinar. Released on October 7, 2015, these recommendations identify evidence-based best practices for engaging with patient groups, as well as provide case examples and tools.

We are pleased to share the recording of this webinar:

PRESENTERS:

  • Sharon Hesterlee (Myotonic Dystrophy Foundation)
  • Patricia Cornet (Bristol-Myers Squibb)
  • Scott Weir (KUMC)

CLICK HERE to view the slides from this presentation.

If you are active on Twitter, you can participate in this ongoing conversation with #PGCT.

CLICK HERE to view recordings of other CTTI webinars.

CTTI Webinar Now Online: Integrating Patient Preferences into the Regulatory Review of Medical Devices

Posted on by Lorri Bingham

On August 20, 2015, CTTI hosted a 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 share the recording of this event:

PRESENTERS:

  • Ross Jaffe, Managing Director, Versant Ventures; Director, National Venture Capital Association; Board Champion, MDIC
  • Kathryn O’Callaghan, Associate Center Director for Science & Strategic Partnerships, FDA CDRH

CLICK HERE to view recordings of other CTTI webinars.

Now Available: Poster on Cost Drivers of HABP/VABP Phase 3 Clinical Trials

Posted on by Lorri Bingham

On October 9, 2015, results from CTTI’s Streamlining HABP/VABP Trials Project were presented in the poster session, Cost Drivers of Hospital Acquired Bacterial Pneumonia and Ventilator Associated Bacterial Pneumonia (HABP/VABP) Phase Three Clinical Trials, at ID Week 2015 in San Diego, CA. This poster explores the drivers of HABP/VABP direct and indirect clinical trial costs and identifies opportunities to lower these costs.

We are pleased to share this poster on our website.

You’re Invited! Upcoming Webinar Presents CTTI Recommendations: Effective Engagement with Patient Groups Around

Posted on by Lorri Bingham

Patient Groups

On Thursday, October 15, 2015, team members from CTTI’s Patient Groups & Clinical Trials project will present the official recommendations on effective engagement with patient groups around clinical trials. Released on October 7, these recommendations identify evidence-based best practices for engaging with patient groups, as well as provide case examples and tools. This webinar is open to the public, and we encourage you to share this invitation with colleagues involved in the clinical trials enterprise.

Webinar Title: Presenting CTTI Recommendations: Effective Engagement with Patient Groups Around Clinical Trials

Date: Thursday, October 15, 2015 Time: 12:00 – 1:00 pm EST

Presenters:

  • Sharon Hesterlee (Myotonic Dystrophy Foundation)
  • Patricia Cornet (Bristol-Myers Squibb)
  • Scott Weir (KUMC)

Link: CLICK HERE to access the webinar during the scheduled time
Meeting number: 733 697 012
Meeting password: cttiPGCT

Or join by phone only:
1-855-244-8681 Call-in toll-free number (US/Canada)
1-650-479-3207 Call-in toll number (US/Canada)
Access code: 733 697 012

To join the conversation on Twitter, follow the #PGCT hashtag and @CTTI_Trials.

Finally! Evidence-based Recommendations & Tools to Maximize Effective Engagement Between Patient Groups & Sponsors

Posted on by Lorri Bingham

While key stakeholders have declared a commitment to create a more effective model for engagement between research sponsors, investigators and patient groups, thus leading to more efficient, quality-driven clinical trials, no evidence-based guidelines for best practices have existed until now. How and when should patient groups be engaged in the research and development continuum? How do patient groups and sponsors of research best assess each other’s interests, expertise and assets to increase the chances of successful clinical trials and therapy development?

In January 2014, CTTI initiated the Patient Groups & Clinical Trials (PGCT) Project to find evidence-driven, actionable solutions to these questions. Today, we are pleased to release the culmination of these efforts at the BIO Patient and Health Advocacy Summit session titled, Best Practices for Industry and Patient Organization Collaboration in Clinical Trials. (CLICK HERE to view the slides presented at this session.) CTTI’s PGCT official recommendations identify best practices for engaging with patient groups, as well as provide case examples and tools.

CLICK HERE to download a copy of the PGCT recommendations.

To join the conversation on Twitter, follow the #PGCT hashtag and @CTTI_Trials.

New Publication: CTTI Presents a Systematic Review of Respiratory Tract Infection Trials Available on ClinicalTrials.gov

Posted on by Lorri Bingham

Annals of the American Thoracic Society published Respiratory Tract Infection Clinical Trials, 2007-2012: A Systematic Review of ClinicalTrials.gov on September 11, 2015. CTTI, in collaboration with the FDA, analyzed data from respiratory tract infection (RTI) trials registered between 2007 and 2012 on ClinicalTrials.gov to identify gaps in antibacterial research and inform possible interventions to the public health crisis of increasing antimicrobial resistance. Of the 69,779 trials registered between 2007 and 2012, 1,377 (2%) of these were RTI trials, which were found to be more likely than other infectious-disease or non-infectious-disease trials to be funded by industry. However, stratification of RTI trials by registration year revealed that industry funding is decreasing from approximately 65% of RTIs in 2007-2008 to 46% in 2011-2012. RTI trials more frequently evaluated vaccines compared to infectious-disease trials overall. Lower respiratory tract infection (LRTI) trials were mainly focused on bacterial pathogens (78.5%) and the majority of LRTI trials registered between 2007 and 2012 were treatment-focused; however, a multivariable logistic regression analysis indicated that a treatment-focused RTI trial was associated with decreased odds of publication. Despite the increasing emergence of multidrug-resistant microbes, currently FDA-approved antimicrobials were more commonly tested in RTI trials, and the number of trials investigating novel antimicrobial agents was low. Throughout the study period, the number of LRTI trials overall and prevention-oriented LTRI trials did not increase. This was partly attributed to a decrease in industry sponsorship and funding. These findings should prompt an examination of resource allocation in infectious-diseases trials and LRTI trials in particular.

“Our study is the first to characterize the spectrum of RTI trials. This is a critically important topic, as LRTIs are the most common cause of communicable-disease-related deaths worldwide and in the United States (28% and 45%, respectively) but comprise only 3% of infectious-disease trials.”
– Ruopp, et al.

Figure 2

Analyzed from data on ClinicalTrials.gov, Figure 2 displays the declining financial support from industry for RTI trials.

 

To read the publication, click here.