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FDA to Organize Two-Day Web Conference with CTTI to Gather Feedback from Stakeholders to Update ICH E6

Posted on by Hannah Faulkner

The International Council for Harmonisation (ICH) is revising ICH E6 Good Clinical Practice (GCP) and requests stakeholder feedback to inform the process. The U.S. Food and Drug Administration, in collaboration with CTTI, will help connect the issues by organizing a free two-day public web conference for discussion of ICH E6 on Thursday, June 4, and Friday, June 5, from 10:00 a.m. – 1:00 p.m. EDT.

This public web conference, “Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice,” will help the ICH Expert Working Group (EWG), which is tasked with updating this guideline, learn from stakeholder experiences with the current GCP guideline (ICH E6(R2)). The conference will also allow the EWG to reflect on the guideline’s applicability to the changing clinical trials landscape. Topics for discussion will include:

  • Experiences with applying the current guideline to clinical trials
  • Applying GCP to innovative trial designs
  • Digital technology tools and GCP
  • Other topics relating to GCP

This stakeholder engagement web conference will help inform the discussions of the EWG as the group works on developing a responsive updated guideline. Members of the EWG will provide an overview of the ongoing work to update the guideline and will subsequently hear presentations from multiple stakeholders on their experiences with ICH E6(R2).

The registration process gives registrants an opportunity to submit questions. We will address themes from questions submitted before Tuesday, May 26, during a session on Friday, June 5. Please note the following regarding question submissions:

  • Submissions must be in English.
  • Anyone can submit questions or comments.

Time slots for stakeholders to provide oral comments during the second day of the web conference are now filled. Please consider submitting questions when registering or sending written comments to cttievents@dm.duke.edu (External Link Disclaimer).

For additional information on the ICH E6 revision efforts, please see the ICH E6(R3) Concept Paper and other materials at www.ich.org. Meeting details are available on FDA’s website.

Register today!

CTTI Report Finds Contracting and Budgeting are Significant Pain Points for Study Start-Up

Posted on by Hannah Faulkner

It’s no secret that the entire clinical trials ecosystem is affected by painfully slow study start-up timelines. CTTI recently sought to investigate the factors that influence this crucial problem. After conducting a literature scan, in-depth conversations with sites and sponsor groups, and a working group meeting, CTTI released a report showing that budgets and contracts are significant contributors to delays.

During exploratory conversations, CTTI repeatedly heard from stakeholders that several process, infrastructure, and motivational factors influence timely budget and contract negotiations:

  • The language in clinical trial contracts or clinical trial agreements (CTAs) varies considerably among sponsors and may be subject to interpretation. Indemnification, intellectual property, publication rights, subject injury, and confidentiality continue to be contentious topics, often delaying timelines in order to reach an agreement.
  • Further complicating the issue is the variability of infrastructure and resources among organizations. Limited or inexperienced staff, personnel turnover and/or the lack of investment in streamlining technology can influence the efficiency of the process.
  • Motivational factors may also influence budget and contract negotiation timelines. For example, having a key opinion leader in a trial or participating in a blockbuster trial are potential motivators.
  • Sites often reported feeling underpaid for their time and resources, while sponsors noted unintended administrative costs, site overhead fees and/or additional expenses outside the intended protocol budget.

Based on the findings, the working group determined that streamlining clinical trial budgets would be more feasible and have a greater potential impact than streamlining contracts. Three potential areas for improvement include infrastructure and resource needs, communication and transparency, and budget review and negotiation methods.

CTTI hopes the findings from this initial research will spur further conversation on improving budget and contract processes in study start-up and motivate others to continue the search for sustainable solutions. Read the full report.

Share Your Experiences on Switching to Remote Visits for Clinical Trials during COVID-19

Posted on by Hannah Faulkner

Now, more than ever, there is urgency to adopt telehealth for clinical research. But where do we begin?

Exchanging ideas is the first step. As a valuable member of the clinical trials community, we need your help – please tell us how your clinical trials are evolving to use telehealth (this can be using phone, Skype, or FaceTime for remote visits and/or using other telemedicine approaches) in light of the COVID-19 pandemic. What have you tried? What works well? What is challenging?

CTTI will collect experiences and input from stakeholders across the clinical trials ecosystem through Thurs., May 7 at 11:59 p.m. ET, aggregate your feedback, and summarize best practices and insights. We will publically share this information via a webinar in the near future.

By exchanging ideas on how to use telehealth in clinical trials during this pandemic, we can learn from each other and – ultimately – run better, more efficient clinical trials moving forward. Thank you and we look forward to hearing from you.

Recording Now Available: Designing High-Quality COVID-19 Treatment Trials

Posted on by Hannah Faulkner

Designing clinical trials during a pandemic presents significant challenges. However, it is possible to build trials that yield high-quality results without slowing down the process.

In a webinar from Thurs., April 23, titled “Designing High-Quality COVID-19 Treatment Trials,” a diverse group of stakeholders presented perspectives that can inform COVID-19 researchers on best practices for designing and quickly launching trials that improve quality and minimize burdens on front-line hospital staff and study participants. The slide deck and recording from this webinar are now available here.

This is the second in a series of CTTI webinars designed to provide help and direction to those seeking to improve trials related to COVID-19. The first webinar, “Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID-19 Pandemic,” is available here.

Advancing Clinical Trials in the Age of the COVID-19 Pandemic

Posted on by Hannah Faulkner

The COVID-19 pandemic has turned our world upside down. Every aspect of our ways of life are experiencing unprecedented disruptions.

For the clinical trials community, we are seeing steep declines in patient enrollment and, in some cases, complete pauses of trials. A report from Medidata showed an 83 percent decrease in new patients entering trials in China in February 2020 compared to February 2019 and similar trends have been seen in other countries. In the first half of March this year, the U.S. has had a 62 percent decrease in new patients entering trials.

This pandemic has thrust clinical research into the limelight like never before and – while daunting and challenging – the scientific community is answering its collective call-to-duty with impressive vigor and determination. COVID-19 is literally changing the way the world does science.

Researchers and scientists are saying, according to the New York Times, “Never before have so many experts in so many countries focused simultaneously on a single scientific quest with so much urgency – exchanging information as it becomes available and launching clinical trials that rely on laboratories and hospitals from around the world.”

Developing a vaccine against COVID-19 and new treatments for those infected with the novel coronavirus is of paramount importance and we applaud those efforts. We must also do what we can to advance new and ongoing clinical trials for all medical products across all diseases and therapies in the age of the coronavirus pandemic. For some patients, participation in a clinical trial may be their last chance at extending or even saving their life. We owe them that chance.

On March 18, the U.S. Food and Drug Administration (FDA) released guidance “to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.” The European Medicines Agency (EMA) and Medicines & Healthcare products Regulatory Agency have also released similar guidance documents.

In response to the FDA’s new guidelines, the Clinical Trials Transformation Initiative, a leader in driving change across the clinical trials ecosystem, surveyed the research community about experiences and best practices on the conduct of clinical trials of medical products during the current COVID-19 crisis. The survey’s findings were presented along with shared experiences from a patient representative, academic medical center and independent IRB on a CTTI-hosted webinar on Mar. 31.

The survey’s findings, along with additional learnings from the webinar, identified the following best practices for conducting clinical trials during this pandemic:

  1. Keep Participants Informed
  2. Perform Ongoing Risk-benefit Assessment
  3. Communicate with IRB/IEC and Regulatory Authorities
  4. Pause (Most) New Study Starts & Enrollment
  5. Pivot to Remote Study Visits
  6. Switch to Remote Monitoring
  7. Document all changes with COVID-19 Tag

These best practices were released by CTTI this week as a free online resource.

During this pandemic, the clinical trials community is rising to meet the challenge upon us. Most immediately, we must respond to the urgent public health need to prevent, diagnose and treat COVID-19 and we must seize the unprecedented opportunity to collaborate and conduct clinical trials for a vaccine against this disease in the most efficient way possible. The clinical trials enterprise can also use this experience to adopt these more collaborative and innovative approaches as routine on a wider scale moving forward. Our ultimate goal is that we will drive for change that leads to further development of medical products currently under investigation and, as a result, saves lives.

This article was originally published by CTTI Executive Director Pamela Tenaerts on LinkedIn on 4/20/20.

CTTI to Host Webinar on Designing High-Quality COVID-19 Treatment Trials

Posted on by Hannah Faulkner

As the research community races to identify safe and effective COVID-19 therapies, researchers are in need of accelerating trial design without sacrificing quality. The Clinical Trials Transformation Initiative (CTTI) will discuss designing high-quality COVID-19 treatment trials via a webinar Thursday, April 23 at 9:30 ET.

Speakers will include:

  • Janet Woodcock, FDA, CDER
  • Ed Cox, Regeneron Pharmaceuticals, Inc.
  • Martin Landray, University of Oxford
  • John Marshall, WHO Clinical Characterization and Management Working Group, Unity Health CA
  • Karlin Schroeder, Parkinson’s Foundation
  • Fergus Sweeney, European Medicines Agency
  • Ann Meeker O’Connell, Vertex Pharmaceuticals

During the webinar, COVID-19 researchers will glean best practices for designing trials that are streamlined, high-quality, and minimize burdens on front-line hospital staff and study participants.