CTTI News

CTTI Paper Features Recommendations for Incorporating Patient and Site Perspectives in Digital Health Trials

Posted on by Hannah Faulkner

Digital health technologies offer the potential to improve the conduct of clinical trials. If harnessed correctly, they can reduce patient burden, streamline operations, and optimize data collection. The key to unlocking these benefits is to ensure that patient and site perspectives are considered during the planning process. CTTI has released a new manuscript in Contemporary Clinical Trials Communications that features the first evidence-based set of recommendations for incorporating patient and site perspectives in digital health trials.

CTTI’s comprehensive recommendations for planning trials using digital health technologies offer advice across several research study topics, including:

  • Engaging patients and sites in planning clinical trials using digital health technology
  • Maximizing value and minimizing burden for study participants
  • Addressing challenges for investigative sites

This comprehensive set of recommendations was developed by first conducting a survey of 193 potential research participants regarding their willingness to use digital health technology in clinical trials as well as their preferences and concerns. Site experiences and preferences were captured through qualitative interviews with 12 different investigators. CTTI then collated this information and conducted an expert meeting over two days. Attendees, including patients, investigators, regulators, sponsors, and technology experts, presented key findings and discussed strategies and implications.

Because patients and site personnel offer important perspectives on how best to incorporate digital health technology into a trial, CTTI recommends their input be taken into account early and often. Ensuring their engagement helps stakeholders incorporate digital health technologies in the most efficient way possible, which can help to advance clinical trials and accelerate the development of new treatment options.

Read the full manuscript.

CTTI Paper Offers Suggested Solutions for Improving Good Clinical Practice Training

Posted on by Hannah Faulkner

A new CTTI paper, detailing its findings from a project designed to assess challenges and burdens associated with Good Clinical Practice (GCP) training, has published in Contemporary Clinical Trials Communications.

The paper, “More than a Box to Check: Research Sponsor and Investigator Perspectives on Making GCP Training Relevant,” outlines feedback on GCP training gleaned from interviews CTTI conducted with clinical investigators and research sponsors. While interview respondents recognized that GCP training addresses critical tasks necessary for the quality conduct of clinical trials, many found it burdensome and repetitive—one interviewee said the training was seen as “just another box to check off.”

CTTI’s paper also highlights respondents’ suggestions for navigating these challenges, noting a need for significant improvement in the design, content, presentation, and training of GCP guidelines. These findings, together with other evidence, informed CTTI’s Investigator Qualification recommendations for alleviating the burden of training and making it more engaging and applicable to real-world clinical research scenarios.

Navigating the New Normal: CTTI Announces Playbook on Best Practices for Conducting Trials During COVID-19

Posted on by Hannah Faulkner

 

As the world adapts to the COVID-19 pandemic, CTTI is leading the charge to help the clinical trials ecosystem evolve and move forward. Since March 2020, CTTI conducted a series of initiatives to help the research community successfully navigate the challenges associated with adjusting trials that were underway when the pandemic hit. These initiatives and resulting best practices are captured in a new playbook, Best Practices for Conducting Trials During the COVID-19 Pandemic.

CTTI gathered experiences and learnings from across the clinical trials ecosystem via public surveys and discussions, and communicated these findings during two CTTI-hosted webinars. These efforts extrapolated best practices for conducting clinical trials with new FDA guidance on COVID-19, as well as solutions to help investigators shift to remote and virtual visits during the COVID-19 pandemic.

Through this initial work when the pandemic first hit, CTTI identified eight essential best practices on how to conduct clinical trials during the pandemic. These key points, fully outlined in the new COVID-19 playbook, recommend that stakeholders:

  1. Keep participants informed
  2. Perform outgoing risk-benefit assessment
  3. Communicate with IRBs and regulatory authorities
  4. Adjust new study starts and enrollment based on risk
  5. Pivot to remote study visits
  6. Switch to remote monitoring
  7. Be flexible
  8. Document everything with COVID-19 tags

The new document provides detailed information on how stakeholders can best integrate these important recommendations into their ongoing clinical trials while providing several additional resources to fully support these efforts. This comprehensive resource will help researchers adapt to the changing clinical trial landscape and continue to conduct successful studies during the pandemic.

New CTTI Project Aims to Increase the Use of Clinical Trial Endpoints Derived from Digital Technologies

Posted on by Hannah Faulkner

While digital health technologies (DHT) offer clinical trial researchers the promise of more efficient and potentially accurate data, there are very few examples of digitally derived primary endpoints that can support regulatory labeling claims.

To address this issue, CTTI is conducting a new project that will build on previous novel endpoint work to create additional resources and recommendations to drive the use of digitally derived, functional outcomes as key endpoints in clinical trials to support regulatory decision-making.

Once the project is complete, stakeholders can look forward to resources such as:

  • Best practice recommendations on the “standards of evidence” needed to qualify a DHT-derived novel endpoint
  • Glossary of terms for digital health endpoints
  • Summary of interview results
  • Expert meeting summary

CTTI will conduct glossary term evaluations, literature reviews, and landscape assessments – as well as in-depth interviews and multi-stakeholder expert meetings – to collect data that will inform the new recommendations and resources.

These solutions will serve to increase the use of meaningful DHT-derived novel endpoints in clinical trials for labeling claims and help to advance the benefits of running digital health trials, including the capture of more meaningful and higher quality research data.

New CTTI Project Aims to Increase Inclusion of Minority Populations in Clinical Trials

Posted on by Hannah Faulkner

The lack of diversity in U.S. clinical trials limits understanding of the risks and benefits of medical products. To address this issue, CTTI is conducting a new project to demonstrate the value of engaging racial minorities, ethnic minorities, and women in clinical trials.

The objectives of this new project include:

  • Identify organizational-level practices, and related metrics, that increase the inclusion of diverse patient populations in the development lifecycle of medical products.
  • Identify incentives & disincentives for decision-makers to invest sufficient resources in organizational-level practices that increase diversity in clinical trials.
  • Identify factors that yield a clinical, scientific, and financial return on investment from engaging diverse populations in clinical trials

CTTI will conduct in-depth interviews with key stakeholders, create real-world case studies, and develop process and outcome evaluation metrics designed to build fit-for-purpose, scalable strategies to increase diversity in clinical trials.

By collecting data that demonstrates the importance of including underrepresented patient populations, CTTI aims to help increase the participation of diverse populations throughout the development lifecycle of medical products.

CTTI Paper Discusses Development of Patient Group Engagement Tool to Benefit Clinical Trials

Posted on by Hannah Faulkner

Patient groups can offer sponsors a wealth of support that can boost clinical trial efficiency but there are few frameworks to help identify priorities. In a new preprint manuscript, CTTI discusses the development and application of an evidence-based prioritization tool to help sponsors and patient groups identify mutually beneficial engagement activities.

Using a list of 31 engagement activities previously developed through its Patient Groups and Clinical Trials (PGCT) work, CTTI conducted qualitative, semi-structured interviews with representatives from patient groups and sponsor organizations to refine the list to 24 unique engagement activities across the medical product development lifecycle.

The findings were used to develop the web-based tool, which helps sponsors and patient groups identify mutually relevant, high-priority engagement activities.

The manuscript explains how the tool walks users through a three-step decision-making process that results in a visual priority matrix grid. It helps sponsors and patient groups form meaningful partnerships and solidify expectations, goals, and specific roles that will benefit the design, conduct, and dissemination of research, in alignment with CTTI’s recommendations [link] for effective patient group engagement.

Read the full manuscript.

CTTI Paper Discusses Suitability of Patient Registries for Embedded Clinical Trials

Posted on by Hannah Faulkner

Embedding clinical trials into patient registries can lead to high-quality, efficient prospective research. However, methods for assessing which registries are appropriate to serve as the platform for the conduct of a clinical trial can be problematic for researchers. A new CTTI paper in Therapeutic Innovation & Regulatory Science identifies and describes the essential characteristics, processes, and practices required to embed and conduct registry-based clinical trials to support regulatory decision-making.

Taking an evidence-based, collaborative approach, CTTI completed a comprehensive review of registry-embedded clinical trials and worked with the Research Triangle Institute (RTI) to conduct 25 expert interviews. These efforts were followed by a multistakeholder meeting with 42 members of academia, industry, government, and patient advocacy organizations.

The resulting data indicates that registries can create a sustainable and reusable infrastructure to support embedded clinical trials when certain characteristics are present including relevancy, robustness, reliability, and assurance of patient protections.

What’s more, registry-embedded clinical trials offer opportunities to:

  • Identify high-quality sites
  • Reduce duplicative data and site workload
  • Recruit patients efficiently
  • Reduce lost to follow-up incidents
  • Enhance timelines
  • Reduce costs

CTTI noted a prevailing need for guidance on how to assess the suitability of existing registries and plan new registries that can support embedded clinical trials. The paper includes CTTI recommendations, suggested practices, and decision trees that help meet this need. These resources are designed to help clinical trial stakeholders effectively leverage patient registries to create high-quality, embedded clinical trials that benefit relevant patient populations.

CTTI Feasibility Studies Database Adds New Resources

Posted on by Hannah Faulkner

CTTI has added 172 new studies to its Feasibility Studies database, bringing the total number of resources up to more than 440 studies. This free, one-of-a-kind repository of feasibility studies using digital health technologies to capture data in clinical research can help the entire clinical trials community to better match appropriate technologies to their research goals.

For example, sponsors can use the resource to help support trial design, while investigators in the field can use it to make decisions regarding which technology would be most useful for their research. This centralized repository could also help alleviate future development of redundant studies and contribute to the design and implementation of high quality, efficient trials.

The database includes a systematic search of scientific literature indexed in PubMed and published between January 2014 and June 2019.

Do you know about a study we should add to the database? CTTI invites others in the digital health trials community to submit relevant studies on an ongoing basis.

Recording Now Available: Strategies for Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Trials

Posted on by Hannah Faulkner

Given the recent statistics showing that COVID-19 disproportionately affects racial and ethnic minority communities, the recruitment and enrollment of diverse populations are crucial. In a webinar from Thurs., June 18, “Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Clinical Trials,” CTTI discussed the barriers to enrolling a diverse patient population and key strategies to overcome them. The presentation and full slide deck are now available here.

The webinar covers useful insights and best practices gathered from key stakeholders across the clinical trials ecosystem, including investigators, sponsors, participants, and many others.

Presenters included:

  • Christina Brennan, Northwell Health
  • Richard Knight, American Association of Kidney Patients
  • Fabian Sandoval, Emerson Clinical Research Institute
  • Anand Shah, FDA, OC
  • Cassandra Smith, Janssen

Several CTTI efforts are underway—including conducting surveys, holding webinars, and developing resources to help the clinical trials ecosystem adapt and move forward during this pandemic.

Web Conference Recordings Available: Listen to Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice

Posted on by Hannah Faulkner

A recording for FDA and CTTI’s two-day Pan-American web conference held June 4-5, “Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice,” is now available.

Khair ElZarrad, FDA, and Pamela Tenaerts, CTTI, opened the web conference by welcoming attendees. Then, FDA and CTTI shared background on ICH E6 and the plan to engage with stakeholders to inform the discussions of the ICH Expert Working Group (EWG), which is tasked with updating the guideline and making it more responsive to advances in clinical trial design and conduct. Multiple stakeholders then shared their experiences with ICH E6(R2). Overall, the web conference was a testament to the importance of having engagement at the heart of the development of E6.

View the slide decks for each day of the web conference to learn more from each presenter.

For additional information on the ICH E6 revision efforts, please refer to the following materials: