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 Tackles 3 Issues in Clinical Trials with New Projects

At CTTI, we are continuously looking for practices that will increase the quality and efficiency of clinical trials. In 2014, three new topics have been added to our portfolio:

  1. Conducting Trials Using Data Registries: Demographic, disease, and outcome data collected in clinical observational registries often overlap with data gathered for clinical trials. Integrating clinical trials within observational data registries may offer opportunities to avoid duplicative data collection and increase efficiency while decreasing clinical trial costs. Objectives for this project include identifying upfront costs and operational adjustments required to utilize a data registry for a clinical trial, as well as recommending best practices for conducting randomized registry trials.
  2. Data Monitoring Committees (DMCs): As the use of DMCs has increased and evolved over the past 40 years, critical issues have emerged. A few of these issues include differences in DMC roles and responsibilities, which contributes to confusion and unclear expectations, as well as a lack of a clear plan for preparing the next generation of DMC members. Objectives for this project include understanding the current landscape of DMC use and conduct, clarifying the purpose of and rationale for using a DMC, and describing effective communication practices between independent DMCs and other trial stakeholders.
  3. Investigator Turnover: While an enormous amount of time and resources are spent initiating new investigators into the clinical trial process, there continues to be a high turnover rate for investigators. As many as 40% of investigators annually choose not to participate in another FDA-regulated trial. This high rate of attrition impacts site and overall trial performance. Objectives for this project include obtaining a more thorough understanding of the factors that influence investigators’ decisions to leave the clinical research practice, as well as defining the impact of investigator turnover on industry and society.

 

The Possibilities of Conducting Randomized Clinical Trials using Electronic Data in the Mini-Sentinel Environment

On May 15th Richard Platt, MD, MS, of Harvard Pilgrim Healthcare, and Patrick Archdeacon, MD, of the FDA, spoke at a CTTI-hosted webinar titled Developing Approaches to Conducting Randomized Trials in the Mini-Sentinel Environment. During this teleconference, Platt and Archdeacon summarized the collaborative work of CTTI and Mini-Sentinel investigators exploring the potential for building on the Sentinel’s health-plan-based teams and data infrastructure to facilitate multi-center clinical trials. A recently released report, Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database, fully describes the project and results. Their talk concluded with an explanation of the follow-up phases of this work, which will likely include convening working groups to further advance the concepts put forth in this report and collaborating with other partners.

We are pleased to share the recording of this webinar with the public, and we encourage interested parties to learn more about the Mini-Sentinel.

 

Improving Human Health through Large Simple Trials

“Randomized clinical trials remain the most reliable means of identifying the drugs, devices, and treatment strategies that will improve human health.”
– 
Zubin J. Eapen, MD, MHS, Michael S. Lauer, MD, and Robert J. Temple, MD

On May 13-14, 2013, CTTI hosted an expert meeting on the need to streamline the conduct of large simple trials (LSTs) in the U.S. This meeting convened a broad array of engaged stakeholders including regulators, government sponsors of clinical research, members of academia and industry, patient advocates, clinical investigators, and other interested parties. The primary objective of this meeting included discussing the following:

  • Findings from a survey of practices
  • Strategies that companies are using to implement LSTs
  • The challenges to LSTs

The summary of this expert meeting is now available on the CTTI website.

Additionally, the key takeaways from this expert meeting were captured in a recent JAMA Viewpoint publication, The Imperative of Overcoming Barriers to the Conduct of Large, Simple Trials. Co-authored by three of CTTI’s LST Project Team Members (Zubin J. Eapen, MD, MHS, Michael S. Lauer, MD, and Robert J. Temple, MD), this perspective piece highlights how the U.S. healthcare system stands to benefit from larger, simpler, less expensive randomized trials. This article also touches on the possibility of leveraging existing data collection platforms to enhance patient enrollment in LSTs, as well as the ability of funding opportunities to encourage streamlined trial design.

The authors concluded, “With the current opportunities to streamline trials and leverage existing clinical data, conducting large, simple trials is more possible than ever and presents a path forward for advancing human health.”

For more information about CTTI’s LST Project, CLICK HERE.