Regulatory Submissions + Approvals
CTTI Article Sheds Light on Participants’ Views of Mobile Clinical Trials
While adoption of mobile technologies presents many opportunities to enhance the quality and efficiency of clinical research, questions remain on patients’ preferences surrounding the use of mobile technologies in clinical trials. To help trial sponsors and others maximize the potential offered by mobile technologies, CTTI surveyed a group of potential research participants and recently published findings from the survey in Contemporary Clinical Trials Communications.
The survey results, which include responses from 193 individuals ages 23 to 83, shed light on the respondents’ perceptions of and willingness to participate in mobile clinical trials. In the survey, participants were presented with two similar hypothetical clinical trial scenarios: 1) relying on participants’ use of wearable and other mobile technologies outside of the clinic setting to collect study endpoints, and 2) relying on traditional in-clinic follow-up appointments with study staff to collect study endpoints. About 81 percent of respondents said they were willing to participate in the hypothetical mobile clinical trial, while only about 51 percent were willing to participate in the similar traditional clinical trial.
If given the option of participating in either scenario, the majority of respondents (76 percent) said they would prefer to participate in a mobile trial over a traditional one, citing greater convenience, fewer in-person visits, and perceived greater data collection accuracy offered by the mobile technology. Respondents were willing to use a variety of technologies―including mobile apps, wearable devices, and ingestible sensors―provided they were comfortable, convenient, and easy to use.
The survey also collected data about the aspects of mobile clinical trials that cause participants concern. Those who are less familiar with technology or do not use a smartphone said they are less likely to participate in a mobile clinical trial. Nearly half of respondents reported that they would not participate in a trial if there were no guarantees that their data would remain confidential, while others expressed concern about seeing a doctor less frequently in a mobile clinical trial setting.
CTTI’s findings contributed to the development of recently-announced recommendations and resources that help the research enterprise maximize the opportunities of mobile technologies to advance the development of new medical products. Related work and resources can be found as part of CTTI’s broader Mobile Clinical Trial program.
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.
Webinar Now Available: CTTI’s New Recommendations for Engaging Patients and Sites in Mobile Trials
A recording is now available of the public webinar on Thurs., Feb. 21, to launch CTTI’s new recommendations for incorporating patient and site perspectives in mobile clinical trials. The webinar was led by patient advocate Cindy Geoghegan and Virginia Nido of Genentech, a member of the Roche Group.
CTTI conducted qualitative and quantitative research to better understand the perceptions of patients and site personnel, and convened experts and leaders across the clinical trials enterprise to develop actionable recommendations and resources.
“Patients are attracted to the possibilities of greater convenience and greater access to clinical research—fewer visits, less time away from work and family, and less burden on their caregivers,” Geoghegan said. “Our goal was to enhance the experience for both patients and hard-working site staff.”
The resulting recommendations are designed to help research sponsors engage patient and site perspectives in planning mobile trials, maximize value and minimize burden for study participants, and address challenges for investigative sites.
“One of the key messages is the importance of planning,” Nido said. “We are new to this as an industry, and we need to plan for and address these new challenges in order to maximize the benefits of mobile technology in clinical trials.”
This is the final of four sets of recommendations CTTI has released as part of its Mobile Clinical Trials (MCT) Program. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies and, in 2018, it unveiled new solutions for using mobile technologies for data capture in clinical trials, and recommendations for using decentralized clinical trials. Additionally, they build on previous CTTI work—including our Quality by Design and Patient Groups and Clinical Trials recommendations—that emphasizes the involvement of many stakeholders, including patients and sites, in trial design.
CTTI Unveils New Recommendations for Incorporating Patient and Site Perspectives in Mobile Trials
CTTI released new recommendations and resources today for engaging patients and sites when planning clinical trials using mobile technologies. These recommendations have the potential to help sponsors, CROs, and other stakeholders gain the full benefits of using mobile technologies in clinical trials, including remote participation, increased protocol adherence, and participation by a more diverse population.
While buy-in from stakeholders is critical to the success of mobile trials, little was known about patient and site perspectives until CTTI conducted surveys and interviews with patients and investigative site personnel to assess perceived benefits and barriers.
The resulting recommendations have the potential to help research sponsors:
- Engage patients and sites in protocol design, technology selection, and pilot testing
- Maximize value and minimize burden for study participants by setting patient expectations, protecting privacy, returning data, enhancing patient-site interactions, and providing technical support
- Address challenges for investigative sites, from contracting and budgeting to evaluating site readiness and implementing effective and streamlined training
“CTTI’s recommendations and resources are designed to take our understanding of patient and site needs in mobile clinical trials to the next level,” said Bill Wood, associate professor at the School of Medicine at the University of North Carolina at Chapel Hill. “With these new insights, sponsors and researchers can plan and conduct mobile trials that work better for everyone involved, streamlining the clinical research process and accelerating the development of critical new therapies.”
The recommendations are the fourth set generated through CTTI’s Mobile Clinical Trials (MCT) Program, following recommendations on developing novel endpoints generated by mobile technologies, using mobile technologies for data capture in clinical trials, and planning and conducting decentralized clinical trials. Additionally, they build on previous CTTI work—including our Quality by Design and Patients Groups and Clinical Trials recommendations—that emphasizes the involvement of many stakeholders, including patients and sites, in trial design.
CTTI to Launch Recommendations for Engaging Patient and Site Perspectives in Mobile Clinical Trials
CTTI will host a public webinar on Thurs., Feb. 21, to announce new recommendations and resources for incorporating patient and site perspectives when planning and conducting mobile clinical trials.
“Acceptance and adoption by key stakeholders is critical to the widespread use of mobile technologies in clinical trials,” said CTTI Executive Director Pamela Tenaerts. “However, very little was known about patient and sites’ perspectives until our work shed light on what they see as significant benefits and barriers. Our new recommendations account for these perspectives and provide a valuable resource for optimally deploying mobile clinical trials.
“Further, they build on previous CTTI work—including our Quality by Design and Patient Groups and Clinical Trials recommendations—that emphasizes the involvement of many stakeholders, including patients and sites, in trial design. Engaging these groups early and often is the key to running better trials.”
CTTI conducted surveys and in-depth interviews to better understand the perceptions of patients and clinical investigators, and convened experts and leaders across the clinical trials enterprise to develop actionable recommendations and resources.
The resulting recommendations are designed to assist research sponsors in:
- Engaging patient and site perspectives in planning clinical trials using mobile technologies, including protocol design, technology selection, and pilot testing
- Maximizing value and minimizing burden for study participants, including setting patient expectations, protecting privacy, returning individual data, enhancing patient-site interactions, and providing technical support
- Addressing challenges for investigative sites, from contracting and budgeting to evaluating site readiness and implementing effective and streamlined training
This is the final of four sets of recommendations CTTI has released as part of its Mobile Clinical Trials (MCT) Program. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies and, in 2018, it unveiled new solutions for using mobile technologies for data capture in clinical trials, and recommendations for planning and conducting decentralized clinical trials.
The free webinar will begin at noon ET and will be led by patient advocate Cindy Geoghegan and Virginia Nido of Genentech, a member of the Roche Group.
CTTI Article Finds that Patients and IRBs are Amenable to Early Enrollment Strategy
A CTTI article recently published in JAMA Network Open shows that an early enrollment strategy for research on healthcare-associated pneumonia is acceptable to patients, investigators, and institutional review boards (IRBs). This strategy has the potential to speed enrollment in trials for critical new antibiotic therapies by allowing patients to be approached and consented to before being diagnosed with pneumonia.
Through its ABDD HABP/VABP Studies work, CTTI conducted qualitative interviews with 52 stakeholders—including patients at risk for pneumonia, caregivers, study investigators and coordinators, and IRB representatives—as part of formative research to assess the acceptability of the approach.
The study found that patients and caregivers had no concerns about patients being approached early and having their records monitored before they developed pneumonia. They believed that patients would be able to understand consent information before diagnosis, and shared their preferences for opt-out procedures.
IRB representatives were also supportive of an early enrollment strategy, and investigators and study coordinators indicated that the approach would not be burdensome.
CTTI Study Shows More Efforts Are Needed to Stimulate Pediatric Antibacterial and Antifungal Drug Trials
In an article recently published in Pediatrics, CTTI researchers assess the impact of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) on pediatric antibacterial and antifungal drug trials.
The study, which evaluated pediatric trials conducted between 2007 and 2017, found that nearly two-thirds of pediatric antibacterial and antifungal drug trials were conducted under BPCA or PREA. These trials were more likely to collect pharmacokinetic data and report results than non-BPCA/PREA trials.
However, the overall number of pediatric antibacterial and antifungal drug trials was low, representing less than 1 percent of pediatric trials overall. These trials also rarely enrolled infants up to 30 days old.
The findings show that, while federal legislation is likely having an impact on pediatric antibacterial and antifungal drug trials, more efforts are needed to stimulate these trials and improve the reporting of results.
This study was conducted as part of CTTI’s ABDD Peds Trials Project, which focuses on creating efficient, evidence-based processes to accelerate the development of safe and effective pediatric antibacterial drugs.
CTTI Examines Stakeholder Perceptions of Mobile Clinical Trials: Latest Expert Meeting Summary Now Available
The use of mobile technology holds the promise for higher quality, more efficient clinical trials, allowing remote participation in study activities, reducing patient burden, and facilitating the involvement of a more diverse population.
Critical to the widespread adoption of mobile technology in clinical trials is positive reception by key stakeholders. However, until recently, very little was known about the possible benefits and barriers perceived by investigators and trial participants. To address this issue, CTTI conducted qualitative and quantitative research to better understand perceptions, and reviewed the findings in a multi-stakeholder expert meeting (see one-page summary) that included investigators, patient partners, regulators, technology experts, sponsor representatives, and other groups.
At the meeting, experts underscored that successful adoption of mobile technology requires
rethinking how trials are designed and conducted. At the same time, they noted that many of the factors that define high-quality trial design remain the same, whether or not mobile technology is used. They also agreed on:
- The importance of involving patients early and often in trial planning and design;
- Ensuring that participants remain engaged and are able to easily communicate with site staff;
- Selecting and tailoring devices based on study design; and
- Addressing the unique concerns that stakeholders have around mobile clinical trials, including patient confidentiality, missing or inaccurate data, maintaining patient engagement, and a lack of uniformity among processes, devices, and platforms.
As a next step, the CTTI MCT Stakeholder Perceptions Project team will use the findings from this meeting to inform the development of recommendations for designing and conducting trials with mobile technology to best meet the needs of patients and sites.
CTTI Article Explores Facilitators and Barriers Perceived by Investigators to Successful Pediatric Antibacterial Drug Trials
Growing rates of antibiotic resistance have made the development of new antibacterial therapies an urgent public health need. This is especially true for the pediatric population, where it may take up to 10 years for clinical trials to determine safety and dosing information.
A CTTI article recently published in Contemporary Clinical Trials Communications shares findings from a survey of 73 investigators to determine facilitators and barriers to the successful conduct of much-needed pediatric antibacterial drug trials. The survey was conducted as part of CTTI’s Peds Trials work.
As outlined in the article, almost all investigators identified two factors as very important facilitators: having strong site staff and adequate funding. Other facilitating factors were related to staff expertise. Investigators rated parent concerns and obtaining consent as the most critical barriers. Other barriers included concerns about the number of blood draws and other invasive procedures, as well as having overly narrow eligibility criteria.
The survey findings suggest three areas in which to focus efforts to help facilitate ongoing pediatric antibacterial drug development:
- Improving engagement with parents of children who may be eligible to enroll in a pediatric antibacterial drug trial.
- Broadening inclusion criteria to allow more participants to enroll.
- Ensuring adequate staffing and establishing sustainable financial strategies, such as funding pediatric trial networks.
These results were used to develop CTTI’s actionable recommendations for facilitating and improving antibacterial drug trials in the pediatric population.