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CTTI Unveils New Database of Feasibility Studies on Mobile Technologies in Clinical Research
Mobile technologies present exciting opportunities for researchers to monitor participants outside of the clinical setting. However, with new solutions entering the market daily, it can be challenging to decide which technology option will be most effective for a particular trial.
To help stakeholders address this issue, CTTI has established a searchable online database of pilot studies that assess the feasibility of various mobile technology solutions. The Interactive Database of Feasibility Studies for Mobile Clinical Trials, part of CTTI’s Mobile Clinical Trials Program, is the first publicly available resource that contains a catalogue of published feasibility studies related to the use of mobile technologies in clinical research.
A CTTI manuscript recently published in npj Digital Medicine, describes how this tool will enable sponsors and researchers to capitalize on information gained from 275 previous pilot studies to reduce risk and optimize the effective use of wearables and other devices in clinical trials. The database will allow users to search by therapeutic area, technology type, participant characteristics, and other variables to explore a range of issues surrounding mobile technology, such as sensor performance and algorithm development.
“We are excited about the opportunities presented by this new resource,” said CTTI Executive Director Pamela Tenaerts. “CTTI is continually striving to provide relevant recommendations surrounding the rapidly changing field of mobile technology. The database aligns nicely with CTTI’s comprehensive set of resources that will help stakeholders adopt mobile technologies to make clinical trials more effective.”
Resources from CTTI extend beyond the database—it also has created a set of recommendations and a tool that can be used to select mobile technologies for data capture in clinical trials.
CTTI plans to regularly maintain and update the database to give online users easy access to the most current knowledge on the use of mobile technologies in clinical trials. Viewers can also help grow the resource by submitting a paper to the database.
Five New Members Join CTTI Executive Committee
CTTI is pleased to announce that its Executive Committee will welcome five new distinguished thought leaders. These experts hold impressive track records in implementing change at many levels of the health care and research system, from regulatory bodies to thoe drug development pipeline.
- Steven K. Galson has spent more than 20 years in government service at regulatory agencies.
- Michael Kolodziej is an expert on payment reform, personalized medicine, and practice care delivery transformation in oncology.
- Theodore Lystig provides leadership and guidance in the use of robust statistical and research design methods.
- Rod MacKenzie focuses on global clinical development and advancement of medicines.
- Pierre Meulien works to improve and accelerate the drug development process across Europe.
“These new Executive Committee members are leaders in their fields,” said CTTI Executive Director Pamela Tenaerts. “Their guidance and passion to improve clinical trials will help ensure CTTI can achieve its goals in a rapidly evolving ecosystem.”
The five new Executive Committee members join a group of thought leaders whose knowledge and experience enables CTTI to make meaningful improvements in clinical research.
“These experts will broaden and strengthen the committee’s knowledge in a number of key areas, from clinical research design to quality assurance to drug development,” said CTTI Executive Committee Chair Mark McClellan. “We are confident that they will make a significant contribution to CTTI’s work to move the clinical trials enterprise forward.”
Steven Galson Michael Kolodziej Theodore Lystig Rod MacKenzie Pierre Meulien
CTTI Webinar Highlights the Importance & Benefits of Quality by Design
A recent CTTI webinar brought together stakeholders from across the clinical trials enterprise for an overview of Quality by Design (QbD), existing CTTI resources, and how QbD is being implemented in the real world.
QbD is defined as the absence of “errors that matter”—or, those errors that could jeopardize the ability to 1) protect patients during the trial, and 2) obtain reliable results and meaningful information from the trial. CTTI started working on QbD in 2011, with a focus on addressing ineffective clinical trial monitoring. It was determined that monitoring should be viewed as only one component of an overall quality framework. From there, CTTI went on to develop a broad set of evidence-based recommendations and resources to help drive adoption of QbD.
During the webinar, CTTI walked stakeholders through its QbD Toolkit, which is split into three sections that allow users to:
- Learn about QbD;
- Introduce QbD to their organizations via workshops and printable resources; and
- Adopt QbD within their organizations.
CTTI also reviewed other available resources, such as the QbD Principles document, a key tool for QbD implementation.
Jean Mulinde, a senior policy advisor for the FDA, then spoke about why quality is important to clinical trials.
“QbD should be implemented at the clinical trial level and may be one component of an organization’s overarching quality management system,” Mulinde said. “Implementing QbD serves to focus the protocol and all of the operational plans necessary to implement the protocol on critical processes and data from the outset of a trial.”
Representatives from both academic and private organizations also shared their successes in QbD implementation. Hamid Moradi, a faculty member and researcher at University of California-Irvine, said that his organization hosted a CTTI-led QbD workshop to increase buy-in, which received a positive response from attendees. Moradi also discussed the QbD working group established at UC Irvine.
“This team will be a resource to investigators to help them better design and conduct their trials using QbD principles,” he said.
Currently, CTTI is working on additional QbD resources to support implementation, which it aims to announce within the next year.
Now Available: Summary of the March Patient Engagement Collaborative Meeting
The FDA, in collaboration with CTTI, convened the second in-person meeting of the Patient Engagement Collaborative (PEC) in March at the FDA’s White Oak Campus in Silver Spring, Md. A summary of the meeting is now available.
The primary objective of the PEC’s most recent meeting was to discuss a “how-to guide” to help patients and patient groups navigate engaging with the FDA. Ideas for new resources included a patient ambassador training program and informational marketing campaigns to meet patients where they live and work.
The PEC, a joint initiative of the FDA and CTTI, has 16 members who were chosen from nearly 200 patients and patient advocates. The members’ discussions help to inform the FDA’s efforts to engage patients meaningfully in medical product development and other regulatory discussions.
This effort is facilitated by provisions in the 21st Century Cures Act of 2016 and the Food and Drug Administration Reauthorization Act of 2017.