Interacting with Regulators

CTTI Shares New Insights on Early Enrollment, Barriers to Remote Clinical Trials, and Improving Investigator Trainings at PRIM&R Advancing Ethical Research Conference

Posted on by Lorri Bingham

CTTI will present findings during three sessions at the upcoming PRIM&R Advancing Ethical Research (AER) Conference.

On Mon., Nov. 6, CTTI will share data on stakeholder perceptions of early informed consent and enrollment in clinical trials. While early enrollment could improve the ability to conduct trials that evaluate the efficacy and safety of treatments for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), questions remain about implementing it ethically and effectively. CTTI will share findings from its HABP/VABP Studies Project on the acceptability of an early informed consent approach for high-risk patients and essential information that should be shared with key stakeholders.

On Wed., Nov. 8, CTTI will discuss findings from its MCT Legal & Regulatory Project on actual and perceived barriers that may be preventing the widespread use of mobile technology in clinical trials. Presenters will explore potential challenges and opportunities of conducting clinical research remotely, and solicit input from clinical enterprise stakeholders on potential ethics implications. The project is part of CTTI’s Mobile Clinical Trials (MCT) Program.

In a separate session, CTTI will also present findings to date for its Investigator Qualification project and Investigator Community recommendations. The presenter will examine whether current GCP training methods actually provide the knowledge and skills necessary to conduct quality clinical trials. Further, he will detail recently released recommendations that aim to strengthen the clinical trials investigator and study team community through better training and other approaches.

We hope you will join us in San Antonio, Texas, Nov. 5-8 as we share new insights into these noteworthy clinical trials topics.

Presentation: Stakeholder Perceptions on Early Informed Consent for Clinical Trials
Date & Time: Mon., Nov. 6, 3:30 – 4:45 p.m.
Presenters: Amy Corneli (CTTI) and Thomas Holland (Duke University)

Presentation: Clinical Trials Transformation Initiative (CTTI) Mobile Clinical Trials, Legal, and Regulatory Project
Date & Time: Wed., Nov. 8, 11:15 a.m. – 12:30 p.m.
Presenters: David Babaian (Kinetiq), Linda Coleman (Yale University), and Jan Hewett (FDA

Presentation: Beyond Good Clinical Practice (GCP) Training: Expanding the Tool Set for Preparing Investigators
Date & Time: Wed., Nov. 8, 11:15 a.m. – 12:30 p.m.
Presenters: Gerrit Hamre (CTTI)

Finding Solutions to Legal and Regulatory Challenges of Conducting Mobile Clinical Trials

Posted on by Lorri Bingham

Mobile clinical trials (MCTs) offer several potential advantages, such as greater patient convenience, efficiencies in data collection, potential for novel endpoints, and enhanced participant retention.

However, despite the successful conduct of several MCTs for regulatory submission, the MCT model has yet to be widely adopted. This is due in part to presumed legal and regulatory issues in the U.S., such as the complexity of navigating different state medical licensing laws, patient and investigator oversight, and issues with the drug supply chain of custody.

In July 2017, CTTI convened a multi-stakeholder expert meeting to explore the legal and regulatory challenges inhibiting more widespread practice of MCTs, and to identify potential solutions. A meeting summary is now available highlighting main points from the discussion, including the following:

  • Highly varied state laws and regulations need to be thoroughly understood and recorded in an accessible location, e.g., a public database.
  • Guidance from regulatory bodies is needed to define principal investigators’ responsibilities regarding patient care oversight and potential delegation of activities,
  • Trials with a mobile clinical component should not be held to higher standards than traditional trials.
  • Patients and regulatory agencies should be engaged in trial design early in the development phase.

CTTI’s MCT Legal and Regulatory Project team will leverage themes and specific solutions from the multi-stakeholder discussions to develop recommendations and tools that will help address legal and regulatory challenges currently associated with MCTs.

 

This work is part of CTTI’s MCT Program, which is also exploring other topics and barriers related to planning for and conducting MCTs.

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.