Access to Clinical Trials

CTTI Updates DCT Recommendations in Response to COVID-19

Posted on by Hannah Faulkner

COVID-19 forced the clinical trials ecosystem to plan and conduct research in remote or virtual settings. In an effort to support this shift, CTTI is launching a project to update its Decentralized Clinical Trials (DCT) recommendations to ensure they reflect the latest learnings and emerging best practices from the pandemic.

CTTI’s current DCT recommendations, which launched in 2018 and focus on the use of telemedicine, mobile and local healthcare providers, and related topics, were the most frequently downloaded document on CTTI’s website in 2020, reflecting the increased demand for decentralized solutions in times of COVID-19.

This new project aims to support the accelerating adoption of DCT solutions in clinical trials going forward. The updated recommendations will focus on selecting and operationalizing DCT solutions, ensuring effective safety monitoring, and appreciating the needs and perspectives of investigators, sites, and participants.

This effort builds on CTTI’s initial recognition that running a DCT does not have to be all or nothing. DCTs can be completely virtual, but many will be partially decentralized using a hybrid approach. Regardless of where a trial falls on the decentralized continuum, it is always important to:

  • Plan ahead as much as possible
  • Involve all stakeholders early and often
  • Focus on what matters
  • Communicate and be transparent

Sponsors and CROs can use the revised recommendations to design a fit-for-purpose, efficient DCT—one that can reduce patient burden, improve enrollment, and more closely replicate real-world populations and scenarios.

Recording Now Available: The State of U.S. COVID-19 Treatment Clinical Trials Public Webinar

Posted on by Hannah Faulkner

A recording for CTTI’s public webinar, The State of U.S. COVID-19 Treatment Clinical Trials, held Apr. 15, is now available. In the webinar, moderated by CTTI Acting Executive Director Leanne Madre, CTTI presented findings from an analysis of data downloaded from the database for the Aggregate Analysis of ClinicalTrials.gov (AACT) on the state of U.S. COVID-19 treatment studies. The presentation included an overview of the U.S. COVID-19 clinical trials landscape, the availability of results, and changes in the portfolio as time has progressed. The presenters – Robert Califf, Verily and Google Health; Harlan Krumholz, Yale School of Medicine; and Deborah Zarin, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard University – discussed how the findings from the analysis can be applied to improvements needed across the clinical trials enterprise.

View the full slide deck for the public webinar to learn more from each presenter.

For additional information on CTTI’s COVID-19 work, please visit this web page.

CTTI to Host Free Public Webinar on the State of U.S. COVID-19 Treatment Clinical Trials Featuring Robert Califf, Harlan Krumholz, and Deborah Zarin

Posted on by Hannah Faulkner

CTTI will host a free public webinar on the state of U.S. COVID-19 treatment clinical trials on Thurs., Apr. 15 at noon EST.

The U.S. has recently marked the one year anniversary of the official declaration of the COVID-19 pandemic by the World Health Organization. The pandemic thrust clinical research into the limelight like never before and – while daunting and challenging – the scientific community answered its collective call-to-duty with impressive vigor and determination. But our work continues and this anniversary provides an important opportunity for reflection, discussion and evaluation.

Many have pointed to a large number of initiated clinical trials as evidence of successful research in response to the global health crisis. However, the true measure of success should be in actionable and reliable research results that are available to inform clinical, policy and research decisions related to the diagnosis, treatment, and prevention of COVID-19 and its variants.

In this webinar, moderated by CTTI Acting Executive Director Leanne Madre, CTTI will present findings from an analysis of data downloaded from the database for the Aggregate Analysis of ClinicalTrials.gov (AACT) on the state of U.S. COVID-19 studies. The presentation will include an overview of the U.S. COVID-19 clinical trials landscape, the availability of results, and changes in the portfolio as time has progressed. The presenters, including Robert Califf, Verily and Google Health; Harlan Krumholz, Yale School of Medicine; and Deborah Zarin, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University, will discuss how the findings from the COVID-19 analysis can be applied to improvements needed across the clinical trials enterprise.

CTTI Announces New Playbook for Designing High-Quality, Diverse COVID-19 Trials

Posted on by Hannah Faulkner

As the pandemic continues to endure worldwide, CTTI is leading the way in uncovering best practices for conducting COVID-19 trials. Following up on its first playbook focusing on conducting successful trials during the pandemic, CTTI is now releasing a second playbook with eight essential principles for high-quality, diverse COVID-19 trials.

These elements, fully outlined in the new COVID-19 playbook, recommend that stakeholders:

  1. Learn from the past and what’s being done now
  2. Make the time to design right, but move quickly
  3. Adequately power trials
  4. Randomize trials
  5. Maintain ethics
  6. Collaborate on study design
  7. Engage and enroll racial and ethnic minorities
  8. Use a core set of inclusion and exclusion criteria and endpoints
  9. Collaborate and coordinate

Beginning in April 2020, CTTI conducted an analysis of COVID-19 treatment trials in ClinicalTrials.gov, met with key stakeholders to discuss best practices for designing these types of trials, and launched a public survey on how to engage racial and ethnic minority patient populations in COVID-19 trials. CTTI communicated the resulting best practices during two CTTI-hosted webinars on designing high-quality COVID-19 treatment trials and engaging racial and ethnic minorities in COVID-19 trials.

These resources can help researchers adapt to the changing landscape and generate meaningful evidence despite the unprecedented challenges presented by the pandemic. Learn more about what CTTI is doing to address clinical trials issues related to COVID-19.

Recording Now Available: The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies Public Summit

Posted on by Hannah Faulkner

A recording for CTTI’s public summit, The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies, held Jan. 13, is now available. The summit, conducted as a webinar, opened with a welcome from Janet Woodcock, Operation Warp Speed; a call-to-action from Robert M. Califf, Verily and Google Health; and included three panel discussions focused on solutions related to scaling master protocols.

The first panel, Practical Solutions to Setting Up Master Protocol Sites, moderated by Pamela Tenaerts, CTTI, with panelists Derek Angus, REMAP-COVID; Laura Esserman, I-SPY-COVID; and Manizhe Payton, ACTIV-2, examined key challenges and potential solutions to starting up new sites including contracting, competing trials, staffing, and IRB submission.

The second panel, Increasing Participant Enrollment in Master Protocols, moderated by Esther Krofah, Faster Cures, with panelists Kousick Biswas, Veterans Health Administration; Dan Cooper, UC Irvine; and Martin Landray, RECOVERY Trial, examined the key challenges limiting participant enrollment including competition with other trials, burden on staff, and discussed potential solutions to overcome hurdles such as co-enrollment.

The final panel, Lessons for the Future, moderated by Mark McClellan, Duke-Margolis Center for Health Policy, with panelists Sam Brown, Intermountain Health System; Adrian Hernandez, PCORnet; and Saye Khoo, AGILE, discussed policy changes needed to improve future pandemic preparedness.

The public summit also addressed the status of COVID-19 clinical trials, including results from a recent CTTI analysis of data from ClinicalTrials.gov, and findings from a pre-summit survey of those involved in COVID-19 treatment master protocols, specifically those involved in setting up new sites or recruiting participants at existing sites.

View the full slide deck for the public summit to learn more from each presenter.

For additional information on CTTI’s master protocols work, please refer to this web page.

This public summit is part of a collaborative effort with the Duke-Margolis Center for Health Policy at Duke University and FasterCures, of the Milken Institute.

CTTI to Host Jan. 13 Public Summit, The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies, Featuring Research & Healthcare Leaders

Posted on by Hannah Faulkner

CTTI will host a public summit, The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies, on Wednesday, January 13. The summit, conducted as a webinar and moderated by CTTI Executive Director Pamela Tenaerts, will include a welcome from Janet Woodcock, Operation Warp Speed; a call-to-action from Robert M. Califf, Verily and Google Health; remarks from Mark McClellan, Duke-Margolis Center for Health Policy; and a panel discussion moderated by Esther Krofah, FasterCures. The panel discussion will focus on solutions related to scaling master protocols, including:

  • Overcoming barriers to starting up sites
  • Increasing participants at existing sites
  • Using the COVID experience to inform our preparedness for future pandemics

“As we’ve learned in the global pandemic, the faster we have reliable answers, the better,” said Tenaerts. “As we look to successfully accelerate progress for COVID-19 treatments, the need for collaborative trials that supply reliable insights has never been greater and in many cases, master protocol studies can provide the solution.”

This public summit will also address the status of COVID-19 clinical trials, including results from a recent CTTI analysis of data from ClinicalTrials.gov and other research, and examine the use of common platforms to optimize the design of master protocols for multiple therapies attempting to treat the same diseases or specific health problems.

The free public summit will be held from 10:30am until noon EST.

This public summit is part of a collaborative effort with the Duke-Margolis Center for Health Policy at Duke University and FasterCures, a Center of the Milken Institute.

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 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.

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.

Webinar to Share Strategies for Including Ethnically Diverse Populations in COVID-19 Trials

Posted on by Hannah Faulkner

COVID-19 disproportionately affects racial and ethnic minority communities, and clinical trial professionals are struggling to recruit the diverse participant demographic needed to find an effective COVID-19 treatment that can work for everyone.

To help, CTTI is hosting a webinar, Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Clinical Trials, on Thurs., June 18 at noon ET to discuss the barriers and solutions to enrolling a diverse patient population.

The webinar will summarize useful insights gathered from key stakeholders across the clinical trials ecosystem, including IRB professionals, investigators, sponsors, participants, and others. These best practices can be applied to help clinical trial teams recruit and enroll diverse populations of participants more effectively.

Anand Shah, FDA, OC, will provide opening remarks and confirmed speakers include:

  • Christina Brennan, Northwell Health
  • Richard Knight, American Association of Kidney Patients
  • Fabian Sandoval, Emmerson Clinical Research Institute
  • Cassandra Smith, Janssen

Mark your calendar today!