Formats

CTTI Discusses Opportunities & Challenges of Innovation in Clinical Trials in Recorded Podcast

Posted on by Lorri Bingham

On March 31, 2015, CTTI’s Executive Director Pamela Tenaerts and Director of Stakeholder Engagement Bray Patrick-Lake joined other thought leaders to discuss the lengthy process of developing a new medicine and explore new ideas that could drastically change the way clinical trials are conducted. This conversation took place on “Business Reinvention with Nancy Lin,” a broadcast on the VoiceAmerica Business Channel.

A RECORDING OF THIS ONE-HOUR PODCAST IS NOW AVAILABLE ONLINE.

Topics examined include:

Does innovation have to be unaffordable? There is probably nothing that affects more Americans than the increasing healthcare cost in this country. While there were more new drugs approved in 2014 by the FDA than the previous 18 years, many of the new drugs’ prices were staggering. As the baby boomers age, the need for medical breakthroughs to fight disease as well as cost control intensifies. How can we continue to innovate without bankrupting our healthcare system?
–Business Reinvention with Nancy Lin

CTTI Participates in PDUFA V Clinical Outcome Assessments Public Workshop

Posted on by Lorri Bingham

Today, CTTI’s Director of Stakeholder Engagement Bray Patrick-Lake joins colleagues at the FDA Clinical Outcome Assessments Public Workshop to discuss accomplishments, challenges, and ongoing efforts in the use of clinical outcome assessments (COAs). Additionally, they group will plan for the future of COA development and utilization in drug development programs, including how to incorporate the patient voice in drug development using well-defined and reliable patient-centered outcome measures. To view the meeting materials, including agenda and background documents, click here.

For a complete list of CTTI’s upcoming events, click here.

CTTI Director Involved in Early Stages of Precision Medicine, Participant Engagement Promises to be Central

Posted on by Lorri Bingham

When President Obama launched Precision Medicine on January 30, 2015, a great deal of excitement burgeoned around the potential to revolutionize our approach to disease prevention and treatment. Two months later, the foundation for the initiative is being laid and CTTI is proud to be involved in the heart of the action.

Yesterday, the NIH announced the creation of a team of experts to host public meetings and seek public input into the design of the initiative. This working group will help chart the course for the President’s Precision Medicine research network. We are thrilled that CTTI’s Director of Stakeholder Engagement Bray Patrick-Lake will serve as co-chair on this newly formed team, alongside Richard Lifton of Yale University School of Medicine and Kathy Hudson of the NIH.

One of the initial goals of the research network is to build a group of at least 1 million research participants who “will volunteer to share their biological, environmental, lifestyle and behavioral information and tissue samples with qualified researchers in a way that protects participant privacy” (NIH). While NIH Director Francis Collins realizes that this is an “audacious endeavor,” many are realizing the need to improve the clinical trials system so that the enterprise is ready and able to keep up with the demands of President Obama’s new program.

CTTI’s work to improve the quality and efficiency of clinical trials is critical to ensure that the promises of Precision Medicine are realized, and participant engagement will be key. Bray Patrick-Lake, who is a patient advocate herself working intensely on patient and stakeholder engagement at CTTI and Duke said, “Unleashing the power of participant engagement in design and operations of the Precision Medicine research activities and novel clinical trial design will allow us to realize the full potential of mobile technology and genomic science. Working in partnership across all sectors of research will finally allow us to make the quantum leap in treatment and prevention that patients have been waiting for.”

Updated AACT Database Now Available on the CTTI Website, New Features Included

Posted on by Lorri Bingham

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 September 2014. 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.

We are pleased to announce that new features to assist usability accompany the most recent AACT Database. Please see the Points to Consider Document for more details. These features include:

  • An additional “readme” document is included in the pipe-delimited text files zip file for users who plan to work with the data extracts in the R statistical computing environment.
  • A target duration (e.g. 180 Days) variable is now included for records where the STUDY_TYPE=”Observational [Patient Registry]”.
  • New “Delayed Results” data elements are included in the pipe-delimited text files and SAS CPORT transport files. This includes a list of studies, provided by the National Library of Medicine, that had submitted a certification or extension request to the 12-month results reporting requirement before September 27, 2014, and the date of the first certification or extension request. For further details, refer to the “readme” documents within the zip files.

Since CTTI released the first AACT database, 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.

CTTI Welcomes New Member Pulmonary Fibrosis Foundation

Posted on by Lorri Bingham

CTTI would like to welcome newest member Pulmonary Fibrosis Foundation. As a leading provider of education and support for the pulmonary fibrosis (PF) community, they represent one of many key stakeholders that CTTI engages to collaboratively improve the quality and efficiency of the clinical trials enterprise. Chief Executive Officer Daniel Rose, MD, will represent the Pulmonary Fibrosis Foundation on CTTI’s Steering Committee.

For more information about CTTI’s organizational structure, including the Steering Committee, CLICK HERE.

Clinical Trial Sponsors Fail to Report Results to Participants, Public

Posted on by Lorri Bingham

Despite legal and ethical mandates for disclosure, results from most clinical trials of medical products are not reported promptly on a registry specifically created to make results of human studies publicly available, according to Duke Medicine researchers.

Among all clinical trials of medical products, those funded by industry were the most likely to be publicly disclosed in a timely fashion, but even then, compliance was poor. Research funded by the National Institutes of Health and academic institutions lagged further, according to findings published by Duke Medicine researchers in the March 12, 2015, issue of The New England Journal of Medicine.

Study authors said the lack of transparency by industry, federal funders and academia has created a critical information gap about investigational drugs, devices and biologic therapies that not only hampers progress, but also violates obligations to patients.

“Patients who participate in clinical research have the expectation that the risk of participation will be offset by the creation of generalizable knowledge and the advancement of science, and that is achieved through the availability of clinical trial results,” said lead author Monique Anderson, M.D., cardiologist and researcher at the Duke Clinical Research Institute. “Sponsors who lead clinical trials have an ethical and legal obligation to publicly report their findings, whether the results are positive or negative.”

To read the press release in full, click here.

*Click here to view the the dataset used for this manuscript. (The first worksheet in this Excel file contains the description and data dictionary; the second worksheet contains the data for the 13,327 studies and all of the variables used in the analysis.)

Leadership Changes at CTTI

Posted on by Lorri Bingham

We are thrilled to announce that Mark McClellan, MD, PhD, has joined CTTI as chair of the executive committee. McClellan is a past FDA commissioner and administrator of the Centers for Medicare & Medicaid Services (CMS). He currently works at the Brookings Institution. He is familiar with CTTI’s mission and work given our respective efforts to help FDA on antibacterial drug development, approval pathways, active postmarket surveillance, and other projects. We are pleased to have someone with McClellan’s experience, leadership, and passion for improving clinical trials join our effort.

We are also delighted to share that John Alexander, MD, MHS, FACC, will join the executive committee representing Duke University. Alexander has already done great work as the Duke steering committee representative, and is excited to increase his involvement at the programmatic level. As a passionate clinical trialist who has spent time working with the PMDA and MHLW in Japan, Alexander will bring that additional international perspective as well.

Historically, as founding members of CTTI, Duke and FDA have named the co-chairs of the initiative, and those same individuals have served as co-chairs of EC. We are now separating these roles: McClellan will be the chair of the EC, and Alexander will join CDR Melissa Robb as co-chairs of the initiative. The three of them will work closely together, along with executive director Pamela Tenaerts, MD, MBA, and the executive committee, to provide strategic leadership for the organization.

Expert Meeting Summary Available: Thought Leaders Lay Foundation for Effective Engagement with Patient Groups

Posted on by Lorri Bingham

Key stakeholders in the clinical trials enterprise have declared a commitment to create a more effective model for engagement between research sponsors, investigators and patient groups, leading to better clinical trials; however, no guidelines for best practices currently exist. Actionable recommendations are needed, and CTTI is working to address this unmet need.

On January 21-22, 2015, CTTI convened a multi-stakeholder group of experts and thought leaders from across the clinical trials enterprise to address barriers to patient group engagement. Specifically, the meeting attendees set out to:

  • Define consensus principles of Patient Group engagement from the 3-way (Industry, Patient Group, and Academia) stakeholder perspectives using case studies of success and barriers
  • Share evidence and key findings from a multi-stakeholder assessment of Patient Group engagement in the Clinical Trial process
  • Gain understanding of the FDA Rules of Engagement and various Conflict of Interest (COI) issues
  • Solicit feedback on evidence to inform recommendations that can further enhance the value to industry, academia and patient groups of mutually beneficial partnerships that engage the patient groups as fully as possible in the complete spectrum of the clinical research enterprise
  • Solicit feedback on benchmarking, metrics, and value of patient engagement in clinical trials for research sponsors

In addition to providing the presentation materials from this expert meeting, we are pleased to share the summary as well. These materials describe the current landscape of patient engagement, and provide an evidence-based foundation for moving forward.

 

CLICK HERE TO VIEW THESE MEETING MATERIALS.