CTTI News

CTTI Cited during the FDA’s Patient Engagement Advisory Committee Inaugural Meeting

Posted on by Lorri Bingham

Findings and recommendations from CTTI’s Patient Groups & Clinical Trials work were presented during the inaugural meeting of the FDA’s Patient Engagement Advisory Committee (PEAC) on Oct. 11-12, 2017.

At the meeting, Bray Patrick-Lake, director of stakeholder engagement, Duke Clinical Research Institute, discussed patient engagement efforts in the clinical trial enterprise and presented work conducted by CTTI to establish best practices for effective engagement with patient groups around clinical trials, which include:

  • Engage the “patient voice” by establishing partnerships from the beginning of the research and development program to improve trial design and execution
  • Clearly define the expectations, roles, and responsibilities of all partners, including the resources being committed, data being shared, and objectives of the program
  • Manage real or perceived conflicts of interest by establishing policies that require full disclosure, transparency, and accountability

The PEAC is composed of patients and caregivers who provide perspective to the FDA on complex issues relating to medical devices, the regulation of devices, and their use by patients. This first meeting brought together patients, patient organizations, FDA, industry, and other medical and scientific experts for discussion on incorporating patient perspectives in the design, conduct, and reporting of medical device clinical trials.

Meeting materials, including slide presentations, are available on the FDA website.

Webinar Coming: Strengthening the Site Investigator Community for a More Sustainable Clinical Trials Enterprise

Posted on by Lorri Bingham

High rates of turnover among clinical site investigators and a shrinking pool of experienced researchers together threaten to harm the efficiency and quality of clinical trials. CTTI has responded to these challenges with actionable, evidence-based recommendations for strengthening and growing the site investigator community.

The recommendations—which are based on stakeholder input, survey and interview results, and an extensive analysis of data from the FDA’s publicly available Bioresearch Monitoring Information System (BMIS) database—will be discussed during a CTTI Webinar on Thurs., Oct. 19, at noon ET. Addressing multiple facets of the clinical trials process from the perspectives of investigators and support staff, trial sponsors, clinical research organizations, and health systems, the recommendations address four major themes:

  • Developing site-based research infrastructure and staff
  • Optimizing trial execution and conduct
  • Improving site budget and contract negotiations
  • Identifying additional trial opportunities for interested investigators

Please visit the webinar page to add this event to your calendar.

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.

New CTTI Investigator Community Recommendations a Focus at SCRS Global Site Solutions Summit

Posted on by Lorri Bingham

Evidence suggests that many investigators are leaving clinical research due to burdens imposed by trial-related responsibilities—a trend that could hinder the quality and efficiency of clinical trials. CTTI is addressing these and other issues in a rollout of evidence-based investigator community recommendations.

At the Society for Clinical Research Sites (SCRS) Global Site Solutions Summit on Sat., Oct. 7, CTTI will present its new set of recommendations designed to support and strengthen the site investigator community through activities aimed at:

  • Developing site-based research infrastructure and staff
  • Optimizing trial execution and conduct
  • Improving site budget and contract negotiations
  • Identifying additional trial opportunities for interested investigators

These recommendations, which lay out practical strategies that can help all stakeholders contribute to building a more supportive and sustainable clinical trials enterprise, were developed through CTTI’s Investigator Community Project.

Panel Discussion: Four Ways to Grow & Maintain a Strong Investigator Community
Date & Time: Sat., Oct. 7, 4:30-5:30 PM EDT (8:30-9:30 PM GMT)
Presenters:

  • Robin Douglas, Site Solutions Director, Site and Patient Networks, QuintilesIMS
  • Doug Peddicord, Executive Director, Association of Clinical Research Organizations
  • Gerrit Hamre, Project Leader, Clinical Trials Transformation Initiative

CTTI Update: Advancing the Use of Mobile Health Technology to Transform Clinical Trials

Posted on by Lorri Bingham

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

Posted on by Lorri Bingham

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

Posted on by Lorri Bingham

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

Posted on by Lorri Bingham

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.

CTTI Presents Recommendations for Clinical Trial Pregnancy Testing Plans from CTTI on Vimeo.

 

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

Posted on by Lorri Bingham

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

Posted on by Lorri Bingham

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

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