Embedding Clinical Trials into Clinical Practice

Topics Included: Data Collecting and Reporting, Innovative Trials, Site Planning

When research data is collected separately from a clinical care setting, studies may produce results that do not reflect the real-world performance of medical products in the populations that will use them. Researchers can bridge these gaps by embedding adequate and well-controlled trials into regular clinical practice. The bigger question that remains is how best to facilitate the integration of interventional trials into clinical practice. 

CTTI has taken on this challenge by creating recommendations and resources, as well as an Embedding Trials Feasibility Survey, to help overcome the obstacles of integrating clinical trials intended for medical product review into clinical practice – potentially resulting in better regulatory and health care decision-making and improved patient care. 

Resources

Site Planning

Embedding Clinical Trials into Clinical Practice

When research data is collected separately from a clinical care setting, studies may produce results that do not reflect the real-world performance of medical products in the populations that will...

Innovative Trials

Registry Trials

The primary purpose of registries has traditionally been to collect data to better understand long-term trends in specific populations.

Innovative Trials | Publications

Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative

Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative

Regulatory Submissions + Approvals | CTTI News

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...

Innovative Trials | Resources

Case Study: Returning Value to Participants without Compromising Study Integrity

Case Study: Returning Value to Participants without Compromising Study Integrity

Innovative Trials | Resources

Case Study: Sharing Data to Promote Patient Engagement

Case Study: Sharing Data to Promote Patient Engagement

Innovative Trials | Resources

Case Study: Using Remote, Smartphone-Based Data Collection to Share Health Insights

Case Study: Using Remote, Smartphone-Based Data Collection to Share Health Insights

Innovative Trials | Resources

Case Study: Optimizing Data Quality and Participant Privacy

Case Study: Optimizing Data Quality and Participant Privacy

Regulatory Submissions + Approvals | CTTI News

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...

Regulatory Submissions + Approvals | CTTI News

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...

Formats

Stage of Trial

Registry Trials

Topics Included: Data Collecting and Reporting, Innovative Trials

The primary purpose of registries has traditionally been to collect data to better understand long-term trends in specific populations. Data from registries hold great potential: they can help make clinical trials more efficient and less expensive and potentially bring new treatments to patients faster. 

To achieve this potential, stakeholders can use CTTI’s recommendations for registry trials to assess, develop, and evaluate registries for the support of clinical research and help meet expectations for FDA review of new products. 

Resources

Site Planning

Embedding Clinical Trials into Clinical Practice

When research data is collected separately from a clinical care setting, studies may produce results that do not reflect the real-world performance of medical products in the populations that will...

Innovative Trials

Registry Trials

The primary purpose of registries has traditionally been to collect data to better understand long-term trends in specific populations.

Innovative Trials | Publications

Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative

Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative

Regulatory Submissions + Approvals | CTTI News

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...

Innovative Trials | Resources

Case Study: Returning Value to Participants without Compromising Study Integrity

Case Study: Returning Value to Participants without Compromising Study Integrity

Innovative Trials | Resources

Case Study: Sharing Data to Promote Patient Engagement

Case Study: Sharing Data to Promote Patient Engagement

Innovative Trials | Resources

Case Study: Using Remote, Smartphone-Based Data Collection to Share Health Insights

Case Study: Using Remote, Smartphone-Based Data Collection to Share Health Insights

Innovative Trials | Resources

Case Study: Optimizing Data Quality and Participant Privacy

Case Study: Optimizing Data Quality and Participant Privacy

Regulatory Submissions + Approvals | CTTI News

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...

Regulatory Submissions + Approvals | CTTI News

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...

Formats

Stage of Trial

Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative

Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative

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

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.