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CTTI Launches New Project to Improve Process for Qualifying Investigators to Conduct Clinical Trials

Posted on by Lorri Bingham

Ineffective or redundant training for investigators wastes time, resources, and does not prepare investigators for the quality conduct of clinical trials. Rather than accepting GCP training as the default solution for qualifying investigators to conduct clinical trials, CTTI is collecting evidence to determine effective and efficient approaches.

While good clinical practice (GCP) training has become the standard for qualifying investigators to conduct clinical trials, little evidence has been collected to determine whether this training is providing the necessary knowledge and skills. CTTI’s new Investigator Qualification Project will evaluate current approaches to investigator qualification, including GCP training, and issue recommendations on effective and efficient methods for investigators to become qualifiehttps://ctti-clinicaltrials.org/projects/investigator-qualification-gcp-trainingd to conduct clinical trials. Investigators, research sponsors, and trial participants are all expected to benefit from an improved investigator qualification process.

CTTI previously released recommendations to address the issue of staff being required to take GCP training before each clinical trial, often multiple times each year. The Investigator Qualification Project is an extension of this work and will focus on the quality of training. CTTI will gather evidence to identify gaps and redundancies in current training, as well as suggest other ways of ensuring that investigators are qualified for the quality conduct of clinical trials.

New CTTI Recommendations Provide Path for More Efficient Clinical Trials Using Clinical Registries

Posted on by Lorri Bingham

Registry Trials

CTTI’s newly released recommendations have the potential to streamline clinical trials by using registry information. Registries are data collection tools typically used to better understand long-term trends in a specific population, such as patients with a particular disease or patients exposed to a certain treatment.

“High-quality registries are an increasingly important source of evidence for regulatory decisions and surveillance, conveying important information, for example, regarding real-world medical product use and outcomes throughout the total product lifecycle,” said John Laschinger, MD, of the U.S. Food and Drug Administration, who helped lead the CTTI work. “Use of high-quality registries as a vehicle for efficient conduct of randomized clinical trials is a proven concept that can be considered for future pre-market trials,” he added.

If registries are designed appropriately, the “real-world” data within them should often be able to meet the expectations of regulatory agencies, and support decisions about medical products. In this regard, CTTI addresses how to assess data quality, ensure patient protections, and link with other data sources. The recommendations apply to both existing and new registries. Following these best practices can assist in evaluating suitability of registry data for regulatory purposes.

“Conducting randomized clinical trials within registries can increase efficiencies in data collection and decrease site workload, potentially leading to significant cost savings,” said Sunil Rao, MD, principal investigator of the successful randomized registry-based clinical trial, SAFE-PCI for Women.

While the scope of this project was limited to registries, many of the principles and tools in these recommendations have the potential to be applied to using health care systems or other existing data sources, such as those available within claims databases, to facilitate more efficient clinical trials.

More information about these recommendations on conducting clinical trials using registries is available both on the Registry Trials Project page and in a webinar recording.

 

*To view the press release of this announcement, click here.

CTTI Publishes Recommendations to Enhance Data Monitoring Committees

Posted on by Lorri Bingham

Improve trial oversight by applying best practices for DMC setup and operation

CTTI has published recommendations to enhance the functioning of data monitoring committees (DMCs) for clinical trials. Sponsors, DMC members, and all those involved in clinical trial design and conduct can apply CTTI’s recommendations to improve DMC operation and the quality of trial oversight, which ultimately benefits patients.

The monitoring of accumulating data in a clinical trial helps to ensure participant safety, as well as the validity and integrity of the trial. For an increasing number of trials, this is accomplished through an independent DMC that can advise on whether to continue, modify, or terminate a trial based on a benefit-risk assessment. Though DMCs play an important role in the oversight of clinical trials, there is considerable variability in how they are composed and operate.

CTTI’s recommendations, which appear in the journal Clinical Trials, address the following areas:

  • Clarifying the role of DMCs
  • Best practices for DMC conduct
  • Effective communication practices
  • Strategies for preparing the next generation of DMC members

The recommendations were developed through a consensus of experts from multiple stakeholder groups after collecting and analyzing data on DMC practices.

Learn more about CTTI’s Data Monitoring Committees Project.

CTTI Points to Stakeholder Engagement, Data-Driven Insights as Keys to Transforming Clinical Trials

Posted on by Lorri Bingham

An editorial appearing in the May 12th edition of Media Planet, a supplement of USA Today, describes the unique methods that CTTI pioneered, and continues to rely on, to transform clinical research.

In Improving Clinical Trials Through Thoughtful Collaboration, Annemarie Forrest, CTTI’s Associate Director of Projects, makes the case that all voices must be included in the conversation if we are going to transform the U.S. clinical trials system. Key to CTTI’s ongoing efforts is the combination of data-driven approaches with the active engagement of all stakeholders, including healthcare providers, regulators, academia, industry, and patients and their families. By fostering dialogue and learning among people who represent a diverse array of backgrounds, knowledge, and experience, CTTI works to enable novel insights about how to accelerate the development of new therapies for the patients and families who need them most.

The tools and recommendations that grow out of CTTI programs and initiatives offer workable, evidence-based solutions. From companies adopting CTTI recommendations to improve the design and conduct of clinical trials to major patient advocacy groups using our tools to streamline trials through their interactions with trial sponsors, CTTI is helping to lead the way toward a better, more efficient clinical trials enterprise.

Find out more about CTTI’s projects and programs here.

CTTI Leads Workshop and Shares Findings at International Meeting on Clinical Trials

Posted on by Lorri Bingham

LOOK FOR US AT SCT ICTMC 2017 IN LIVERPOOL FOR STRATEGIES TO IMPROVE THE QUALITY AND EFFICIENCY OF CLINICAL TRIALS

You’re headed to Liverpool, take this printable one page schedule of CTTI’s presentations at the meeting. See you there!

CTTI will present its recommendations and latest findings in five sessions at the International Clinical Trials Methodology Conference (ICTMC) and Society for Clinical Trials (SCT) Annual Meeting, May 7-10, 2017. We will lead a hands-on workshop on best practices for Data Monitoring Committees, and share our evidence and strategies on embedding randomized clinical trials within registries, developing novel endpoints generated by mobile technology, and more.

Session Title: Formative Research Findings on the Design of an Early Enrollment Clinical Trial on Hospital Acquired Bacterial Pneumonia (HABP) and Ventilator Associated Bacterial Pneumonia (VABP) (Parallel Session 1.5 – Qualitative Research)
Date & Time: Monday May 8 from 1:30–2:30 p.m.
Speaker: Amy Corneli, Duke University
Related CTTI Project: HABP/VABP Studies

Post/our-work/novel-clinical-trial-designs/antibiotic-drug-development/abdd-habp-vabp-studies/er Abstract: Embedding Randomized Clinical Trials within Registries: How Feasible? (Poster Board #152)
Date & Time: Monday, May 8 from 3:40–4:25 p.m.
Speaker: Ted Lystig, Medtronic
Related CTTI Project: Registry Trials

Poster Abstract: Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials: A Clinical Trials Transformation Initiative (CTTI) Project (Poster Board #153)
Date & Time: Monday, May 8 from 3:40–4:25 p.m.
Speaker: Martin Landray, University of Oxford
Related CTTI Project: MCT Novel Endpoints

Workshop Title: Data Monitoring Committees: Multi-stakeholder Recommendations and Hands-on Experience from CTTI and the MRCT Center (Workshop 3)
Date & Time: Tuesday, May 9 from 8:30–10:00 a.m.
Speaker: Annemarie Forrest, CTTI
Related CTTI Project: DMCs

Panel: Clinical / Outcomes Registry-Based Randomised Controlled Trials – The Future for Clinical Trials? (Invited Session 3.5)
Date & Time: Tuesday, May 9 from 8:30–10:00 a.m.
Speaker: Ted Lystig, Medtronic
Related CTTI Project: Registry Trials

Update on CTTI’s Mobile Devices Project: Webinar Recording Now Available

Posted on by Lorri Bingham

CTTI Team Leaders Provide Update on Project Exploring how Mobile Technology Can Be Effectively Leveraged to Improve Clinical Trials

Mobile technologies, including both medical sensors and consumer products, offer exciting new possibilities for clinical research but present substantial challenges as well. Find out how CTTI’s Mobile Devices team is exploring how these technologies can be used to improve patient engagement, remote monitoring, and the collection of new kinds of high-quality, objective data capable of supporting rigorous analysis and regulatory submission.

In a webinar now available as a recording on the CTTI website, project team leaders Cheryl Grandinetti (FDA), Chris Miller (AstraZeneca), and Barry Peterson (Philips) provide an update on CTTI’s Mobile Devices Project, which focuses on scientific and technological challenges affecting the selection and use of mobile technologies in clinical research. The presenters share preliminary evidence gathered from research sponsors and clinical investigators experienced in using mobile devices in clinical trials. Issues addressed in the webinar include:

  • Challenges affecting data management, validation, analysis, and security in mobile technologies;
  • Scientific and technical considerations in mobile device selection; and
  • Approaches to managing and reporting safety signals and adverse events.

After additional evidence and insights from this project are gathered, the team will release recommendations designed to help overcome challenges that are currently hindering the wider use of mobile technologies in clinical trials.

The Mobile Devices Project is one of four distinct efforts taking place through CTTI’s larger Mobile Clinical Trials Program. The MCT Program is developing evidence-based recommendations to guide the widespread adoption and application of mobile technologies in clinical trials. The three other projects within the program are focused on:

  1. Legal and regulatory issues
  2. Development and use of novel endpoints for use with mobile technologies
  3. Stakeholder perceptions regarding the use of such technologies

CLICK HERE to view recordings of other CTTI-hosted webinars.

CTTI Welcomes Six New Members

Posted on by Lorri Bingham

CTTI is pleased to welcome its newest members. CTTI actively engages all stakeholders equally to collaboratively improve the quality and efficiency of the clinical trials enterprise. These organizations bring diverse viewpoints to help CTTI develop solutions with real-world impact.

  • Alpha-1 Foundation: nonprofit promoting research for Alpha-1 Antitrypsin Deficiency
  • Amici Clinical Research: clinical research center in New Jersey associated with a family practice treating 15,000 active patients.
  • Boehringer Ingelheim: global, research-driven pharmaceutical company.
  • Cystic Fibrosis Foundation: nonprofit and world leader in the search for a cure for cystic fibrosis.
  • inVentiv Health: global provider of healthcare & pharma consulting to biopharmaceutical clients.
  • Novartis: global healthcare company that provides solutions to address the evolving needs of patients worldwide.

CTTI now has more than 80 member organizations and several individual patient/caregiver representatives. Learn more about our diverse membership.