CTTI News

Watch CTTI-hosted Webinar on FDA’s Patient Engagement Initiatives

Posted on by Hannah Faulkner

The FDA’s large portfolio of activities to integrate patient engagement throughout the agency was highlighted during a recent CTTI-hosted webinar, now available to watch online. “Patient Engagement in Action: Insights from Patients & the FDA” was held Thurs., Nov. 21, and featured:

  • Andrea Furia-Helms, OC, FDA
  • Michelle Tarver, CDRH, FDA
  • Robyn Bent, CDER, FDA
  • Diane Maloney, CBER, FDA
  • Theresa Strong, Foundation for Prader-Willi Research

“Patients are at the heart of all FDA activities,” Furia-Helms said. She kicked off the webinar with an overview of the history of patient engagement at the FDA. Participants then reviewed patient engagement activities throughout the process of development and regulatory decision-making for drugs, biologics, and devices.

Bent said that patients are uniquely positioned to inform understanding of the therapeutic context for drug development and evaluation. She added that there is a need for more systematic ways of gathering patient perspectives on their conditions and treatment options.

Strong spoke from the perspective of a patient advocate working with the FDA. She said that the patient perspective, particularly with rare diseases, provides context and nuance to the associated symptoms and challenges within a disease. “We bring some experience about living with the disorder and can hopefully help FDA staff understand that laundry list of symptoms, and tease out what is important to patients and what is keeping people living with Prader-Willi syndrome from living healthy and productive lives.”

CTTI and the FDA have partnered on several patient engagement efforts, including co-creating the Patient Engagement Collaborative (PEC) and collaborating on a recent “Enhancing the Incorporation of Patient Perspectives in Clinical Trials” workshop. Additionally, CTTI has developed a robust set of recommendations and resources that help foster effective patient group engagement.

Additionally, answers to the virtual Q&A session are available here.

New Paper Offers Recommendations for Efficient Identification and Training of Investigators

Posted on by Hannah Faulkner

CTTI has released a new preprint paper describing its recommended approach for identifying and preparing investigators and their delegates to perform clinical research. The paper suggests that by moving beyond Good Clinical Practice (GCP) training as a one-size-fits-all solution, sponsors, CROs, investigators, and other research professionals may be able to more efficiently find and train investigators for quality research.

Specifically, CTTI recommends complementing previous GCP training with a fit-for-purpose, risk-based training approach to close identified gaps in knowledge or skills. This multifaceted approach to training can enrich understanding of how GCP principles apply to the conduct of a particular clinical trial and help investigators grasp how to better apply quality principles in a specific setting. Combining the real-world application of GCP principles with role- and protocol-specific instruction has the potential to add greater value to the investigator qualification process, leading to the higher quality conduct of trials.

CTTI used findings from qualitative research with investigators and clinical trial sponsors, along with input from an expert meeting with multiple stakeholders, to develop the recommendations. The research identified gaps and redundancies in the current training of investigators and their delegates, as well as a common theme: the didactic, one-size-fits-all approach most commonly used for training investigators and documenting their qualification often introduces redundancies and minimizes the value of previous training.

In the paper, CTTI offers detailed recommendations for how sponsors, CROs, and site teams can respond to these insights and positively shift the investigator training culture, as well as further discussion of how a targeted learning approach can better prepare investigators and their delegates to conduct quality clinical trials.

CTTI Mobile Tech Recommendations Featured in New Digital Biomarkers Article

Posted on by Hannah Faulkner

The open access journal Digital Biomarkers published a new article this week featuring CTTI recommendations for the use of Mobile Technologies for Data Capture and Improved Clinical Trials. The article articulates the vision of using mobile technologies in clinical trials and highlights CTTI’s evidence-based solutions for using mobile technologies for more efficient assessment of new therapies for patients.

Mobile technologies such as wearables, ingestibles, implantables, portable sensors, and smartphones are designed to collect measures directly from an individual and could potentially contribute to a more complete picture of a patient’s experience in a clinical trial. This article offers recommendations for technology selection, data collection, analysis and interpretation, data management, protocol design and execution, and FDA submission and inspection.

IMPACT-AFib Shares Successes and Lessons Learned from Use of Single IRB

Posted on by Hannah Faulkner

IMPACT-AFib (IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation) is a nationwide pragmatic clinical trial launched in 2017 by collaborators including CTTI. IMPACT-AFib is the first trial conducted under FDA-Catalyst, which incorporates the infrastructure of the FDA’s Sentinel System and enables direct contact with health plan members and providers. To help facilitate large-scale interventional research more efficiently, the collaborators followed CTTI’s recommendations of using a single institutional review board (sIRB).

The study team shared that the use of an sIRB had many positive results, including reducing study start-up time and alleviating administrative burden and costs on sites.

The study team also shared lessons that were learned through the process of using an sIRB:

  • In a multi-center trial, each site has unique requirements, which must be taken into account by study leadership when identifying an sIRB that all sites will find acceptable. Selecting an sIRB that has national experience and is accustomed to dealing with different regulations across states is helpful. In addition, choosing an sIRB that many or all sites have used in the past expedites reliance agreements required between each site and the sIRB.
  • Certain approaches can increase the efficiency of the sIRB approval process and reduce administrative burden for sites. For example, the team behind IMPACT-AFib expedited the process by submitting the initial protocol application to the sIRB that applied to all five sites. They then provided each site a template for the site submissions, noting items that might need to be adjusted according to site-specific considerations.
  • Specific considerations around trial design, such as pragmatic studies leveraging claims data, should be taken into account when submitting to an sIRB. For example, sites for this study are virtual – with patient contact via mailings from their health plans – rather than contacting potential participants in-person at traditional clinical trial sites such as clinics or hospitals.
  • Using an sIRB expedites the amendment process because only one submission is required, which is reviewed and approved for all sites.

Historically, each site’s local IRB has reviewed a trial’s protocol separately in multi-center trials, which results in lengthy approval processes, duplicative work, and differing protocol or informed consent changes among sites. The use of sIRBs can improve the quality and efficiency of multi-center trials by improving oversight and streamlining the review process.

Understanding of sIRB implementation has recently become even more critical; in 2018, the NIH began to require the use of an sIRB for all multi-center trials funded by the NIH, and by 2020, all U.S. institutions involved in U.S.-based cooperative research will be required to use an sIRB.

CTTI has championed the adoption of sIRB review for nearly a decade, developing recommendations and resources to address barriers and assist in the implementation of sIRBs. CTTI is also supporting an NIH workgroup to develop a comprehensive plan for assessing the NIH’s new sIRB policy.

Learn more about the IMPACT-AFib trial on ClinicalTrials.gov.

Now Available: Summary of the September Patient Engagement Collaborative Meeting

Posted on by Hannah Faulkner

A summary of the most recent meeting of the Patient Engagement Collaborative (PEC) is now available. The PEC, which is convened jointly by the FDA and CTTI to discuss how the FDA can bolster patient engagement in its activities, met in September in Rockville, Md.

The primary objective of the PEC’s meeting was to discuss an FDA Ambassador program, which emerged from the group’s March 2019 meeting as a potential avenue to help the patient community engage with the FDA. The PEC discussed potential audiences for the program, as well as the most effective ways to communicate with these audiences. The collaborative also discussed changes the FDA plans to make to its website to make it easier for patients to navigate.

The PEC, which was established in December 2017, is composed of 16 members representing diverse patient communities across the U.S. CTTI and FDA are extending the terms of the initial members by one year, and look forward to engaging new perspectives through an open call for new nominations as current member complete terms in 2021 and 2022. This effort is facilitated by provisions in the 21st Century Cures Act of 2016 and the Food and Drug Administration Reauthorization Act of 2017.

To learn more about other efforts by CTTI and the FDA to further patient engagement, please attend CTTI’s webinar, “Patient Engagement in Action: Insights from Patients & the FDA” on Nov. 17 at noon ET.

FDA Patient Engagement Efforts Highlighted in CTTI-hosted Webinar

Posted on by Hannah Faulkner

Are you curious about what the FDA is doing to integrate patient engagement throughout the agency? Wondering how CTTI is collaborating on some of these efforts? Learn about a variety of initiatives during a CTTI-hosted webinar Thurs., Nov. 21, from 12:00 – 1:00 p.m. ET.

Confirmed speakers for “Patient Engagement in Action: Insights from Patients & the FDA” include:

  • Michelle Tarver, CDRH, FDA
  • Robyn Bent, CDER, FDA
  • Diane Maloney, CBER, FDA
  • Andrea Furia-Helms, OC, FDA
  • Theresa Strong, Foundation for Prader-Willi Research

Participants will discuss ongoing and planned patient engagement initiatives and the anticipated impact of these efforts on patients and clinical research.

Add the webinar to your calendar today.

Webinar Now Available: CTTI’s New Recommendations for Using Real-World Data Sources to Enhance Trial Quality and Efficiency

Posted on by Lorri Bingham

A recording is now available of the public webinar held on Thurs., Oct. 17, to launch CTTI’s new recommendations for using real-world data (RWD) to plan trial eligibility criteria and recruit participants. The webinar was led by Sudha Raman of Duke University, and Jack Sheehan of Janssen Scientific Affairs.

CTTI conducted research and collaborated with stakeholders across the clinical trials ecosystem to develop these recommendations and resources, including three in-depth case studies that elucidate the process of integrating RWD into trial design. The case studies offer a look into the specific challenges faced by each sponsor, how they used RWD to address those challenges, and what they learned along the way.

This project is one in a growing portfolio of CTTI work focused on improving quality in trials and embracing novel trial designs. Other related CTTI efforts include:

  • Co-leading a proof-of-concept study to assess the feasibility of using the FDA Sentinel System infrastructure to conduct randomized clinical trials.
  • Recommendations on how to assess and design registries so that the data can meet expectations for the FDA review of new products.
  • Recommendations and a robust toolkit to help drive a Quality by Design (QbD) approach, which engages a broad range of stakeholders and focuses resources on the errors that matter to decision making.

Both the webinar and CTTI’s latest recommendations and resources can be found on CTTI’s website.

CTTI Investigator Community Recommendations Featured in Contemporary Clinical Trials Communications

Posted on by Lorri Bingham

Why are turnover rates so high for site investigators? What can be done to strengthen the investigator community? CTTI’s exploration of this question and resulting recommendations were published this week in the peer-reviewed journal Contemporary Clinical Trials Communications.

 

CTTI’s work on improving the Investigator Community aimed to better understand why some clinical investigators remain actively engaged in clinical research but others decide to leave it after a single experience. 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’s evidence-based recommendations address the challenges faced by site investigators and offer solutions for improving their experience. The recommendations focus on streamlining research infrastructure and staff, clarifying site budget and contract negotiations, optimizing trial execution and conduct, and providing opportunities to conduct additional trials. CROs, sponsors, health systems, investigators, and others can use CTTI’s work to create a research environment that sustains long-term engagement, and fosters improved quality and efficiency in clinical trials.

CTTI Unveils New Recommendations for Using Real-World Data Sources to Boost Trial Quality and Efficiency

Posted on by Lorri Bingham

CTTI today released new recommendations, resources, and case studies for using electronic medical records (EHRs) and claims data to plan trial eligibility criteria and recruit participants. The work fills an important gap across the clinical trials ecosystem, where the potential benefits of real-world data (RWD) have been widely acknowledged, but few resources have emerged to lead sponsors and others through the process of formally integrating RWD into their trial designs.

“We are excited to unveil this comprehensive set of work, which enables the use of RWE to plan for appropriate eligibility criteria and optimal recruitment in clinical trials,” said CTTI Executive Director Pamela Tenaerts. “These recommendations add to CTTI’s growing portfolio of work focused on improving clinical quality and, when appropriate, embracing novel approaches for better trial design and execution.”

CTTI conducted research and collaborated with stakeholders across the clinical trials ecosystem to develop these recommendations and resources, including three case studies that elucidate the process of integrating RWD into trial design. The case studies offer a look into the specific challenges faced by each sponsor, how they used RWD to address those challenges, and what they learned along the way.

Other CTTI efforts related to the new work include:

  • Co-leading a proof-of-concept study to assess the feasibility of using the FDA Sentinel System infrastructure to conduct randomized clinical trials.
  • Recommendations on how to assess and design registries so that the data can meet expectations for the FDA review of new products.
  • Recommendations and a robust toolkit to help drive a Quality by Design (QbD) approach, which engages a broad range of stakeholders and focuses resources on the errors that matter to decision making.

The RWD recommendations, resources, and case studies can be found on CTTI’s website.

CTTI to Launch New Work Highlighting the Opportunities for Using Real-World Data to Enhance Trial Quality and Efficiency

Posted on by Lorri Bingham

CTTI will host a public webinar on Thurs., Oct. 17, to announce new recommendations, resources, and case studies on how to use real-world data (RWD) to evaluate trial eligibility criteria and recruit potential participants.

“Until now, there have been few resources available to help sponsors and others optimally integrate the use of RWD into their trial design,” said CTTI Executive Director Pamela Tenaerts. “The work we are launching today fills that gap—our new recommendations and resources provide a clear path for using EHR and claims data to help plan eligibility criteria and recruit for clinical trials in a way that enhances quality and efficiency.”

CTTI conducted research and collaborated with stakeholders across the clinical trials ecosystem to develop these recommendations and resources, including three in-depth case studies that detail the specific challenges faced by sponsors, how they used RWD to address those challenges, and what they learned along the way.

This project is one in a growing portfolio of CTTI work focused on improving quality in trials and embracing novel trial designs. Other related CTTI efforts include:

  • Recommendations and a robust toolkit to help drive a Quality by Design (QbD) approach, which engages a broad range of stakeholders and focuses resources on the errors that matter to decision making.
  • Co-leading a proof-of-concept study to assess the feasibility of using the FDA Sentinel System infrastructure to conduct randomized clinical trials.
  • Recommendations on how to assess and design registries so that the data can meet expectations for the FDA review of new products.

The webinar is open to the public and will begin at noon ET, featuring speakers Sudha Raman, Duke University, and Jack Sheehan, Johnson & Johnson/Janssen.