Author: Hannah Faulkner

Now Available: Searchable, Real-Time COVID-19 Clinical Studies Spreadsheet

Posted on by Hannah Faulkner

The urgent need to rapidly identify safe and effective medical therapies has led to a spike in clinical studies on COVID-19. To help the global scientific community address this need, CTTI has created a searchable spreadsheet of COVID-19-related studies posted on ClinicalTrials.gov.  The AACT COVID-19 Trials Spreadsheet is updated daily and was created from a search strategy developed by ClinicalTrials.gov and data from the Aggregate Analysis of ClinicalTrials.gov (AACT) database.

With COVID-19-related studies in one, up-to-date spreadsheet, users can easily search for and sort current information. Each study is listed as a single row in the spreadsheet and the 68 columns include information on goals, interventions, randomization schemes, masking, eligibility criteria, consent, the use of Data Monitoring Committees, etc. As of this posting, there are 1,476 COVID-related studies listed in ClinicalTrials.gov.

CTTI recently used the spreadsheet to characterize COVID-19-related clinical trials in the April 2020 Designing High-Quality COVID-19 Treatment Trials webinar. Details on the search terms used to generate the list of trials posted on ClinicalTrials.gov are also available.

CTTI Webinar on Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote and Virtual Visits

Posted on by Hannah Faulkner

The COVID-19 pandemic has caused many ongoing trials to switch to remote and virtual visits midstream, despite it being unchartered territory for many. On Clinical Trials Day, Wed., May 20, join the Clinical Trials Transformation Initiative (CTTI) for a webinar at 10 a.m. ET, to hear how stakeholders across the clinical trials ecosystem are adapting, overcoming challenges, and discovering new best standards for conducting clinical research via remote and virtual visits.

CTTI recently surveyed stakeholders to identify challenges and solutions for using telehealth for clinical trials, and co-hosted a survey with Evidation Health, Inc. to get insights and perspectives from patients. This webinar will highlight findings from both surveys, and share solutions for switching to remote and virtual visits during an ongoing trial. Jacqueline Corrigan-Curay, FDA, CDER, will provide opening remarks and presenters include:

  • Laura Cooke, Amgen
  • Bray Patrick-Lake, Evidation Health, Inc.
  • Ramya Thota, Intermountain Healthcare, ASCO
  • Pamela Tenaerts, CTTI

By exchanging experiences and ideas, we can work together to fully harness the new opportunities and benefits of using remote and virtual visits for clinical trials.

We hope you can join us for next Wednesday’s webinar.

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.