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CTTI Explores How to Prepare Qualified Investigators and their Delegates: Latest Expert Meeting Summary Now Available

Posted on by Lorri Bingham

Although good clinical practice (GCP) training has long been considered the industry standard for ensuring investigators are qualified for the high-quality conduct of clinical trials, little evidence has been collected to determine whether it actually provides the knowledge and skills to equip investigators and their delegates to conduct clinical trials.

To address this issue, CTTI convened an expert meeting in December 2017 to discuss action that can be taken to inform the efficient and effective qualification of site investigators and their delegates. The meeting (see one-page summary) included representatives from pharmaceutical companies, government, research sites, contract research organizations, patient representatives, and other groups.

Meeting participants collaborated to refine a draft framework defining characteristics synonymous with the quality conduct of clinical trials. They discussed the need to shift the focus from individual investigators to the entire study team and identified value in mentorship, just-in-time training, and peer-to-peer networks to support site personnel in their specific roles. In addition, participants probed how it may be possible to develop and deliver more patient-centric training, foster a culture of learning, and drive the evolution of investigator qualification to include more adult learning approaches and a focus on how to apply knowledge—not just recall it. Attendees also identified the need for a harmonized system to better help sponsors identify suitable sites without mandating specific training.

As a next step in its Investigator Qualification work, CTTI will develop recommendations and resources to improve the quality of trial conduct through optimized approaches to qualifying investigators and their delegates.

CTTI Article Explores Facilitators and Barriers Perceived by Investigators to Successful Pediatric Antibacterial Drug Trials

Posted on by Lorri Bingham

Growing rates of antibiotic resistance have made the development of new antibacterial therapies an urgent public health need. This is especially true for the pediatric population, where it may take up to 10 years for clinical trials to determine safety and dosing information.

A CTTI article recently published in Contemporary Clinical Trials Communications shares findings from a survey of 73 investigators to determine facilitators and barriers to the successful conduct of much-needed pediatric antibacterial drug trials. The survey was conducted as part of CTTI’s Peds Trials work.

As outlined in the article, almost all investigators identified two factors as very important facilitators: having strong site staff and adequate funding. Other facilitating factors were related to staff expertise. Investigators rated parent concerns and obtaining consent as the most critical barriers. Other barriers included concerns about the number of blood draws and other invasive procedures, as well as having overly narrow eligibility criteria.

The survey findings suggest three areas in which to focus efforts to help facilitate ongoing pediatric antibacterial drug development:

  1. Improving engagement with parents of children who may be eligible to enroll in a pediatric antibacterial drug trial.
  2. Broadening inclusion criteria to allow more participants to enroll.
  3. Ensuring adequate staffing and establishing sustainable financial strategies, such as funding pediatric trial networks.

These results were used to develop CTTI’s actionable recommendations for facilitating and improving antibacterial drug trials in the pediatric population.

CTTI Continues to Address Barriers to Single IRB Adoption: Latest Expert Meeting Summary Now Available

Posted on by Lorri Bingham

Using a single institutional review board (sIRB) for multisite trials can improve the quality and efficiency of multicenter clinical trials—and beginning Jan. 25, 2018, the National Institutes of Health (NIH) is requiring use of an sIRB for NIH-funded multicenter clinical research.

To help drive adoption of sIRB review, CTTI has developed several recommendations, resources, and tools for use by the research community, and recently convened an expert meeting to discuss further actions that CTTI, the U.S. Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), and NIH can take to ease the transition. The expert meeting included representatives from academia, government agencies, IRBs, pharmaceutical, and device companies, contract research organizations, and patient groups, with the goal of identifying remaining gaps in knowledge and potential solutions to implementing a sIRB model.

Meeting participants highlighted the need for clarity around language and procedures, and emphasized that early collaboration among parties can mitigate the challenges. Participants felt that the time is right to learn from each other by sharing successful models of sIRB review among the private sector, academia, and government research organizations. Next steps from CTTI will involve new projects and committees to develop additional supportive tools and strategies for implementing sIRB review.

Guest Blog: Ken Getz Calls for Commitment and Consistency to Realize Full Potential of Patient Engagement

Posted on by Lorri Bingham

Ken Getz, director of sponsored research programs and research associate professor, Tufts Center for the Study of Drug Development, Tufts University, offered his insights on patient engagement at CTTI’s 10-year Anniversary Symposium on Tues., Feb. 6. He shares those thoughts here in a special guest blog.

As a veteran observer and analyst of the clinical research enterprise, I am very proud of and amazed by the extent to which the patient engagement movement has touched the entire continuum of new medical interventions development.

New services have been created to improve the participant experience, including electronic informed consent forms and direct-to-patient clinical trials. Regulatory agencies have established mechanisms to gather input into clinical outcomes most relevant to patient communities. Sponsors are supporting more meaningful end-of-trial experiences, such as the return of plain language trial results summaries and e-clinical data to study volunteers. The movement has mobilized stakeholders and stimulated more collaboration than we have ever seen before.

However, while we see a proliferation of patient engagement initiatives and guidelines, there are few signs of standard and consistent commitment and practice. Almost daily, new entrants offer technology solutions that can create more fragmentation and market confusion. We also see wide variability in receptivity to, and implementation of, patient engagement initiatives. Nearly all organizations have vocalized concerns about the financial return, long-term value, and perceived risks of patient engagement.

CTTI is committed to helping organizations work through these barriers and obstacles. I have had the privilege of participating in several CTTI projects, including a recent study that quantified the high expected net present value of patient engagement practices for a typical oncology drug development program.

We must do everything we can to give the patient engagement movement the opportunity to take hold and realize its compelling promise. Only then will clinical research and clinical care best serve the needs of public and patient health.

Clinical Trials Supplement Celebrates One Decade of CTTI Impact

Posted on by Lorri Bingham

Clinical Trials featured a supplement in its March 2018 issue (available online now) celebrating a decade of CTTI’s impact on clinical trials. The supplement includes articles on CTTI’s accomplishments and lessons learned over the last 10 years, its unique methodology, its work to promote patient engagement and clinical trial quality, and the role it can play in addressing ongoing and future challenges. All supplement articles are freely accessible.

Since its inception in 2007, CTTI has conducted more than 25 projects and issued recommendations for strategies to enhance the quality and efficiency of clinical trials. In an introductory article, John Alexander, Duke University; Jacqueline Corrigan-Curay, FDA; and Mark McClellan, Duke University, explore the defining features of CTTI that have allowed it to move the needle toward more efficient, high-quality clinical trials over the last 10 years. In subsequent articles:

  • Pamela Tenaerts, CTTI; Leanne Madre, CTTI; and Martin Landray, University of Oxford, share common themes and lessons learned that have emerged during the course of CTTI’s work, including the importance of engaging many stakeholders, advance planning to address critical issues, and new opportunities presented by technology. Read this article.
  • Amy Corneli, Zachary Hallinan, Gerrit Hamre, Brian Perry, Jennifer Goldsack, Sara Calvert, and Annemarie Forrest, all of CTTI, describe CTTI’s collaborative, five-step methodology: stating the problem and identifying impediments to research, gathering evidence to identify gaps and barriers, analyzing and interpreting findings, finalizing solutions by developing recommendations and resources, and driving adoption through dissemination and implementation. Read this article.
  • Bray Patrick-Lake, Duke Clinical Research Institute, discusses CTTI’s pivotal role in promoting patient engagement in clinical trials through organizational practices, formal project work, and external advocacy efforts. Read this article.
  • Ann Meeker-O’Connell, Johnson & Johnson, and Coleen Glessner, Alexion Pharmaceuticals, explore how CTTI led a transformational shift in moving clinical trial quality from an after-the-fact endeavor, focusing on monitoring and audits, to a core element of clinical trial design. Read this article.
  • Hans-Georg Eichler and Fergus Sweeney, both with the European Medicines Agency, consider key challenges that the clinical trials community continues to face—including globalization, transparency, operational complexity, and expense—and describe the role CTTI can play in addressing those obstacles. Read this article.

Event Recap: CTTI Symposium Celebrates 10 Years of Impact on Clinical Trials

Posted on by Lorri Bingham

In a symposium held Feb. 6, more than 150 attendees, including leaders from across the clinical trials enterprise, gathered to celebrate CTTI’s 10-year anniversary and discuss how CTTI’s work has led to improvements in clinical trials. Highlights from the day included a keynote address by Robert Califf, former FDA commissioner, and engaging panels with stakeholders from across the enterprise on topics including quality by design (QbD), patient engagement, use of a single IRB of record, and the future of clinical trials.

Clinical Trials Reflections & Predictions

In the keynote address, Califf noted that incremental changes to improve clinical trials, including those CTTI has prompted, make a difference—but there is still a lot of work to be done. He went on to describe major trends that are shaping the future of clinical research. Califf’s vision is that patients and healthcare systems will align to produce needed evidence to guide clinical care and medical product use. He also described the culture change required to make research data sharing more prevalent, and how CTTI could help to promote this change.

Improving the Quality & Efficiency of Clinical Trials

A vibrant discussion on QbD followed. Presenters from Amgen and Johnson & Johnson shared how their organizations have implemented CTTI’s QbD recommendations and the benefits observed. Panelists from the FDA and the University of Oxford reiterated the value of dedicating adequate time and attention to the planning phase of clinical trials, despite so many organizations being focused on reducing time to first patient in. QbD is not just about avoiding the inclusion of unnecessary elements in a trial, it is also really thinking about the totality of what you are trying to accomplish.

Engage Early. Engage Often.

The next panel was a powerful testament to the value patient engagement can bring to clinical trials. The patient group Friedreich’s Ataxia Research Alliance and Horizon Pharma shared details of their inspiring partnership and how CTTI’s recommendations have helped them work together effectively. Panelists from Tufts University and DCRI echoed the importance of patient engagement early and often in clinical trials. There is often a disconnect between organizations’ stated commitment to patient engagement and its implementation—CTTI is committed to addressing these barriers and has developed a framework for measuring the return on investment of patient engagement.

Use of a Single IRB for Multi-Center Trials

In discussing the shift to a single IRB of record, a case study from Norwell Health showed how using CTTI’s resources resulted in more trials using a single IRB and improved study startup times. Still, communication can be challenging between the reviewing IRB, human research protections office, and local site investigators. Panelists from OHRP, Celgene, and FDA weighed in on the benefits (e.g., consistency in informed consent documents) and remaining challenges (e.g., how to measure quality IRB review) associated with the single IRB model. Education and resources to aid the transition, including those developed by CTTI, were felt to be critical.

The Future of Clinical Trials

The symposium concluded with a lively panel on the future of clinical trials with thoughts from the FDA, patient groups, NIH, and others. Issues discussed included positive publication bias, data interoperability, economic factors, and the need for innovators to take charge in using platform trials and flexible designs. It was noted that real-world evidence will not solve everything, and some therapeutic areas are advancing more rapidly than others with improvements to clinical trials.

Many great ideas came out of the day to inform future CTTI work. CTTI encouraged those who have implemented CTTI recommendations to share their experiences so the examples can help inform the enterprise.

The presentation slides from the Symposium are now available online.