CTTI Takes on Site Investigator Turnover in New Recommendations
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CTTI Update: Advancing the Use of Mobile Health Technology to Transform Clinical Trials
Mobile technology has the potential to revolutionize clinical trials, but putting mobile clinical trials (MCTs) into action requires consideration of issues such as data integrity, legal and regulatory barriers, scientific and technological challenges, and perspectives of potential trial participants, investigators, and site staff. For the past two years, CTTI’s MCT Program has systematically explored barriers to MCTs, gathered evidence, and convened multiple stakeholders to tackle these issues.
By developing best practices on how to effectively integrate mobile technologies into clinical trials for regulatory submissions, CTTI intends to promote quality, efficient, and more cost-effective research. Recent developments include the following:
- CTTI’s Recommendations for Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials were released in June and are prominently featured in a recent mHealth Action Plan from the Duke-Margolis Center for Health Policy.
- CTTI’s recommendations are accompanied by several practical tools and case examples that describe the process of novel endpoint development for MCTs.
- A survey of potential research participants, as well as in-depth interviews with site investigators on issues related to MCTs, are underway. Analysis of these results will begin this fall and will inform recommendations to overcome barriers to the use of mobile technology in clinical trials as perceived by key stakeholders.
- CTTI presented “Turning Opportunity Into Reality: Real Data and Practical Guidance for Incorporating Mobile Technology in Clinical Trials” at the DPharm Disruptive Innovations Conference in September 2017. The presentation included—as it relates to mobile technology—the patient perspective, tips for dealing with large volumes of data, and engaging with the FDA during trial design, execution, and monitoring.
- Two expert meetings were held in 2017, one on legal and regulatory issues and one on scientific and technological challenges affecting MCTs. Official CTTI recommendations and resources on these topics will be issued in early 2018
CTTI Shares Challenges and Solutions to Enrolling Participants in Pediatric Trials at AAP 2017
At the upcoming American Academy of Pediatrics National Conference, CTTI will offer insights into some of the biggest challenges currently affecting pediatric clinical trial enrollment and conduct. Through a podium presentation and poster sessions, CTTI will share survey-based findings that shed new light on obstacles affecting pediatric trials and discuss possible solutions that can help streamline these studies and reduce burdens on patients, families, and providers.
Although clinical trials are essential for ensuring access to safe and effective therapies for children, many studies struggle to enroll pediatric participants and families and providers often lack information to help them make the best possible treatment choices. This problem is especially acute for children and infants at risk of harm from bacterial infections, many of which are increasingly resistant to antibiotic treatment. For this reason, maintaining a strong pipeline of safe and effective therapies is an urgent priority.
CTTI’s Peds Trials project, part of the larger Antibacterial Drug Development Program, is actively addressing these gaps and has created evidence-based recommendations designed to improve and streamline pediatric trial development and conduct. We hope you will join us in Chicago this Sept. 16-19 as we share new insights into challenges affecting pediatric trial enrollment, including reasons that parents refuse trials and provider perceptions of obstacles.
Poster & Podium Presentation: Obstacles to Pediatric Clinical Trial Enrollment: Why Parents Refuse; Findings from the Clinical Trials Transformation Initiative
Date & Time: Monday, Sept. 18, 12:35 p.m.–12:50 p.m. (oral presentation)
Monday, Sept. 18, 1:00 p.m.–5:00 p.m. (poster session)
Presenter: P. Brian Smith (Duke University)
Poster: Barriers to Pediatric Clinical Trial Enrollment: Findings and Recommendations from the Clinical Trials Transformation Initiative
Date & Time: Monday, Sept. 18, 1:00 p.m.–5:00 p.m. (poster session)
Presenter: P. Brian Smith (Duke University)
CTTI Advances Mobile Clinical Trials at DPharm 2017
Mobile technology has been used in a variety of ways, but it has yet to be widely incorporated into clinical trials—despite its great potential to increase trial quality and efficiency. As part of its Mobile Clinical Trials (MCT) Program, CTTI has implemented four projects to identify and address the challenges related to planning for and conducting clinical trials that use mobile technology. This week, CTTI will present strategies and insights from the program at DPharm 2017 Conference, held in Boston on September 6-8.
At the 2-day conference themed “Disruptive Innovations US,” CTTI will bring together key industry leaders who are collaborating on recommendations for the use of mobile technologies in regulated clinical trials after the point of informed consent. This will include—as it relates to mobile technology—the patient perspective, tips for dealing with large volumes of data, and engaging with the FDA during trial design, execution, and monitoring.
Presentation: Turning Opportunity Into Reality: Real Data and Practical Guidance for Incorporating Mobile Technology in Clinical Trials
Date & Time: Friday, Sept. 8, 2:30–3:10 p.m.
Moderator: Komathi Stem (monARC Biotech)
Panelists: Ray Dorsey (University of Rochester), Cindy Geoghegan (Patient and Partners), and Gary Grabow (Genentech)
Also, at DPharm’s pre-conference program, “Mobile in Clinical Trials,” CTTI will share recommendations that clarify the pathway for developing novel endpoints from data generated using mobile technology in clinical trials.
Presentation: CTTI Findings Are in From Their Mobile Clinical Trials Program: Recommendations on Novel Endpoints
Date & Time: Wednesday, Sept. 6, 9:20–9:40 a.m.
Presenter: Jennifer Goldsack (CTTI)
In addition to Novel Endpoints, CTTI is also working on recommendations to address challenges and opportunities related to Mobile Devices, Legal and Regulatory, and Stakeholder Perceptions, as part of the MCT Program.
Improved Pregnancy Testing Planning for Safer, More Efficient Clinical Trials: Webinar Recording Now Available
Pregnancy testing is necessary in clinical trials if there is a possibility of pregnancy in the study population and embryo/fetal exposure to the study treatment poses a known or unknown risk. However, there is little formal guidance on how pregnancy testing should be conducted to prevent unintended exposure, nor how risks should be clearly communicated to women.
CTTI’s new recommendations help research sponsors, investigators, and institutional review boards develop and review pregnancy testing plans, in an effort to conduct safer, more efficient clinical trials. CTTI also created the Pregnancy Testing Outcomes Predictor for Clinical Trials, a web application that provides a quantitative method for assessing estimated likely outcomes of different pregnancy testing plans.
A webinar recording is now available detailing the new recommendations and web application, including case examples of their use.
View the webinar recording to learn:
- Steps involved in proactive planning for pregnancy testing before the start of a clinical trial
- A new web application to help assess the balance of benefits and burdens of specific pregnancy testing plans
- Ways study coordinators can improve communication so that women receive clear, comprehensive information before joining a clinical trial
- How these new recommendations promote the safe inclusion of women in clinical trials
Visit this page for presenter information and to download a copy of the slides.
Addressing Challenges of Using Mobile Devices in Clinical Trials
Mobile devices hold great potential to transform clinical trials by their ability to capture objective, real-world health data directly from study participants. While this technology shows promise to improve the quality and efficiency of medical product development, questions remain on how to successfully integrate mobile devices for data capture into clinical trials.
On June 16, 2017, CTTI convened a multi-stakeholder expert meeting to further refine solutions to the scientific and technological challenges preventing widespread adoption of mobile devices in clinical trials. A meeting summary is now available, including the following:
- The recommended best practices for studies using mobile devices for data capture do not differ significantly from many of the best practices that we already apply to clinical trials.
- Studies using mobile devices for data capture should not be held to higher standards than traditional trials.
- Efforts to leverage mobile devices for data capture should strive to engage patients in study design and endpoint selection.
The MCT Mobile Technologies Project focuses on using mobile devices in FDA-regulated clinical trials after initial participant consent—in other words, the use of devices for data capture rather than for recruitment, retention, or as the study intervention. The project team will use findings from the expert meeting to develop recommendations and tools that guide the adoption of mobile devices for data capture in clinical trials.
Coming soon: How improved pregnancy testing planning can lead to safer, more efficient clinical trials
CTTI shares new pregnancy testing plan recommendations and an online tool in an upcoming free public webinar
Pregnancy testing is necessary in clinical trials if there is a possibility of pregnancy in the study population and embryo/fetal exposure to the study treatment poses a known or unknown risk. In an upcoming webinar, CTTI will unveil new recommendations and an online tool to help research sponsors, investigators, and institutional review boards develop and review pregnancy testing plans, to conduct safer, more efficient clinical trials.
Attend this webinar to learn:
- Steps involved in proactive planning for pregnancy testing before the start of a clinical trial
- A new online application to help assess the balance of benefits and burdens of specific pregnancy testing plans
- Ways study coordinators can improve communication so women receive clear, comprehensive information before joining a clinical trial
- How these new recommendations promote the safe inclusion of women in clinical trials
Webinar: CTTI Presents Recommendations for Clinical Trial Pregnancy Testing Plans
Date & Time: Thursday, August 24, 2017 12:00–1:00 p.m. ET (GMT-04:00)
Presenters:
- Claire Jurkowski, MD, former medical director, Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb (Retired)
- Jessica Morse, MD, MPH, assistant professor, University of North Carolina School of Medicine
- Evan Myers, MD, MPH, professor, Duke University Medical Center