Author: Hannah Faulkner
CTTI Webinar to Provide Insight on How to Embrace the Value of Patient Engagement
Engaging patients at every stage of clinical research is no longer a “should,” it is a “must”. And, from quick online tools to in-depth financial reports, there are resources that can help you embed patient engagement in your research.
The Clinical Trials Transformation Initiative (CTTI) will host a webinar on Thurs., Feb. 27, at noon ET focusing on actionable resources for identifying patient engagement activities that bring high value – financial and otherwise – to both sponsors and patient groups.
Presenters Joseph DiMasi, Tufts University, and Jaye Bea Smalley, formerly with Celgene, will discuss:
- New findings on the factors that sponsors and patient groups should consider when evaluating potential engagement activities.
- Resources for sponsors to build their own financial model that can be used to estimate the value of patient engagement on key business drivers such as cost, risk, revenue, and time.
- An online prioritization tool that patient groups and sponsors can use to collaboratively identify high-value opportunities to work together.
New Paper Offers Suggested Solutions for Improving Good Clinical Practice Training
CTTI has released a new preprint paper detailing its findings from a project designed to assess challenges and burdens associated with Good Clinical Practice (GCP) training.
The paper, “More than a Box to Check: Research Sponsor and Clinical 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.
Webinar Recording Now Available: CTTI’s Framework for Evaluating the NIH Single IRB Policy
A recording is now available of a CTTI webinar held on Thurs., Jan. 16, which provided a recap of resources available to help implement a sIRB model, as well as an overview of a recent project CTTI undertook to develop a framework that could help in evaluation of the NIH’s single IRB (sIRB) policy. The webinar was led by Cynthia Hahn (Integrated Research Strategy), Stephen Rosenfeld (Secretary’s Advisory Committee on Human Research Protections), and Heather Pierce (Association of American Medical Colleges).
CTTI has been involved in driving adoption of sIRBs for over a decade, but its recent work with the NIH is especially critical this month as changes to the Common Rule take effect, requiring all multi-site research studies to use a sIRB for review.
To develop its evaluation framework, CTTI conducted a literature review and interviews with a diverse set of stakeholders engaged in the process of sIRB adoption.
The webinar outlined the framework’s recommendations for measuring and continuously improving the sIRB model, including:
- Creating a database of organizations that are implementing the sIRB model, as well as which organizations are serving as an sIRB.
- Developing and testing a survey instrument to help evaluate sIRB function and collect metrics.
- Establishing, defining, and routinely collecting and sharing metrics, such as sIRB review time and time spent performing other sIRB-related activities. The team pointed out that although many metrics are quantitative, it is also important to have qualitative metrics to assess the overall quality of the sIRB process. Routine sharing of these metrics would serve to encourage improvement and eliminate unnecessary duplication.
Explore CTTI’s existing resources and recommendations for sIRB adoption on the CTTI website.
CTTI Holds First Meeting to Drive Appropriate & Efficient Use of Master Protocols
Despite a growing enthusiasm for the use of master protocol studies, expertise is critically limited and few resources exist to guide planning and implementation. Working to fill this gap, CTTI held its first Master Protocol Studies expert meeting on Oct. 22-23 to identify strategies, tools, and resources that will help drive appropriate and efficient use of master protocols.
Attendees discussed challenges and potential solutions to planning and running master protocol studies. They also uncovered and agreed on some important common themes:
- The Value is Clear…Master protocol studies are growing in popularity. Their flexible design and highly centralized operational features have the potential to more efficiently ask and answer scientific questions.
- …But a Roadmap is Needed…However, many organizations lack experience in running master protocol studies, presenting major study design and operational challenges.
- …As is Support for Non-Traditional Drug Developers. Publicly available resources are needed to support organizations that want to design a master protocol trial, particularly for non-traditional drug developers such as patient advocacy groups and other nonprofits.
- Be Excited, but Realistic. Enthusiasm for a master protocol approach should be balanced with awareness of its complex infrastructure, long-ranging timelines, and significant upfront planning and resources.
- There are Keys to Long-Term Success. A strong cross-institutional infrastructure, including a robust site network and solid communications approach, are critical to achieving long-term sustainability of master protocols.
Based on these discussions and findings, attendees refined CTTI’s draft roadmap for the successful design and implementation of master protocol studies, and identified a broad set of tools and resources that can drive adoption of master protocols across diverse therapeutic areas.
Learn more about CTTI’s Master Protocol expert meeting and next steps with work to advance master protocol adoption.
New Publication Features CTTI Recommendations For Improving Investigator Qualification
A peer-reviewed article highlighting CTTI recommendations for improving investigator qualification was published this month in Contemporary Clinical Trials. This article details how to implement a more efficient and effective way to identify and prepare investigators and their delegates for the conduct of quality clinical trials, and how to determine whether a site team is a good fit for a particular protocol.
The paper urges organizations to move beyond Good Clinical Practice (GCP) training as a one-size-fits-all solution and recommends pairing existing GCP training with a fit-for-purpose, risk-based training approach to address needed knowledge or skills.
CTTI used findings from qualitative research activities, as well as input from an expert meeting with multiple stakeholders, to identify gaps and redundancies in the current training of investigators and their delegates and recommend practical, action-based solutions.
CTTI Webinar Will Highlight sIRB Adoption Resources & Evaluation Considerations
As more single institutional review board (sIRB) requirements from the Common Rule go into effect this month, CTTI can help organizations navigate the change. A webinar on Thurs., Jan. 16 at noon ET will provide an overview of existing CTTI sIRB work, as well as suggestions for sIRB evaluation.
CTTI has been at the forefront of the sIRB movement for nearly a decade, championing the thoughtful implementation of sIRBs for multicenter clinical trials to enhance patient safety, accelerate study start-up, and improve trial conduct.
The webinar will highlight CTTI’s suite of recommendations and resources, as well as discuss outcomes from a recent collaboration between CTTI and a NIH sIRB policy workgroup. Speakers will include:
- Cynthia Hahn, President, Integrated Research Strategy
- Heather Pierce, Senior Director for Science Policy and Regulatory Counsel, Association of American Medical Colleges
- Stephen Rosenfeld, Chair, Secretary’s Advisory Committee on Human Research Protections
Add the webinar to your calendar today.
CTTI Thanks You For Another Successful Year
As another successful year comes to a close, CTTI would like to wish you good health and happiness this holiday season and prosperity in the New Year.
We achieved many accomplishments in 2019 thanks to the invaluable input and dedication of members, partners, supporters, and staff, including:
- Our Registry Trials and Real-World Data work being cited in the FDA’s 2019 strategic framework for advancing the use of electronic tools to gather health-related data.
- Releasing several new sets of recommendations, case studies, and resources designed to help:
- Incorporate patient and site perspectives in mobile clinical trials.
- Facilitate the implementation of single IRB (sIRB) in multi-center trials.
- Use real-world data (RWD) to plan trial eligibility and recruit participants.
- Decide which technology option will be most effective for a particular trial.
- Identify high-value opportunities for sponsors and patient groups to collaborate.
- Holding a successful workshop on “Enhancing the Incorporation of Patient Perspectives in Clinical Trials,” identifying new opportunities for CTTI to help drive patient engagement in trials.
- And much more!
In the year ahead, we look forward to finalizing and sharing new resources that will help increase quality, diversity, and efficiency in clinical trials, and drive the use of mobile clinical trials, master protocols, and other novel design approaches.
Thank you again for your ongoing support for all of these accomplishments. Enjoy a wonderful holiday season and happy New Year!