CTTI News

Webinar Now Available: CTTI’s New Recommendations for Engaging Patients and Sites in Mobile Trials

Posted on by Lorri Bingham

A recording is now available of the public webinar on Thurs., Feb. 21, to launch CTTI’s new recommendations for incorporating patient and site perspectives in mobile clinical trials. The webinar was led by patient advocate Cindy Geoghegan and Virginia Nido of Genentech, a member of the Roche Group.

CTTI conducted qualitative and quantitative research to better understand the perceptions of patients and site personnel, and convened experts and leaders across the clinical trials enterprise to develop actionable recommendations and resources.

“Patients are attracted to the possibilities of greater convenience and greater access to clinical research—fewer visits, less time away from work and family, and less burden on their caregivers,” Geoghegan said. “Our goal was to enhance the experience for both patients and hard-working site staff.”

The resulting recommendations are designed to help research sponsors engage patient and site perspectives in planning mobile trials, maximize value and minimize burden for study participants, and address challenges for investigative sites.

“One of the key messages is the importance of planning,” Nido said. “We are new to this as an industry, and we need to plan for and address these new challenges in order to maximize the benefits of mobile technology in clinical trials.”

This is the final of four sets of recommendations CTTI has released as part of its Mobile Clinical Trials (MCT) Program. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies and, in 2018, it unveiled new solutions for using mobile technologies for data capture in clinical trials, and recommendations for using decentralized clinical trials. Additionally, they build on previous CTTI work—including our Quality by Design and Patient Groups and Clinical Trials recommendations—that emphasizes the involvement of many stakeholders, including patients and sites, in trial design.

CTTI Unveils New Recommendations for Incorporating Patient and Site Perspectives in Mobile Trials

Posted on by Lorri Bingham

CTTI released new recommendations and resources today for engaging patients and sites when planning clinical trials using mobile technologies. These recommendations have the potential to help sponsors, CROs, and other stakeholders gain the full benefits of using mobile technologies in clinical trials, including remote participation, increased protocol adherence, and participation by a more diverse population.

While buy-in from stakeholders is critical to the success of mobile trials, little was known about patient and site perspectives until CTTI conducted surveys and interviews with patients and investigative site personnel to assess perceived benefits and barriers.

Engaging Patients and Sites Recommendations

The resulting recommendations have the potential to help research sponsors:

  • Engage patients and sites in protocol design, technology selection, and pilot testing
  • Maximize value and minimize burden for study participants by setting patient expectations, protecting privacy, returning data, enhancing patient-site interactions, and providing technical support
  • Address challenges for investigative sites, from contracting and budgeting to evaluating site readiness and implementing effective and streamlined training

“CTTI’s recommendations and resources are designed to take our understanding of patient and site needs in mobile clinical trials to the next level,” said Bill Wood, associate professor at the School of Medicine at the University of North Carolina at Chapel Hill. “With these new insights, sponsors and researchers can plan and conduct mobile trials that work better for everyone involved, streamlining the clinical research process and accelerating the development of critical new therapies.”

The recommendations are the fourth set generated through CTTI’s Mobile Clinical Trials (MCT) Program, following recommendations on developing novel endpoints generated by mobile technologies, using mobile technologies for data capture in clinical trials, and planning and conducting decentralized clinical trials. Additionally, they build on previous CTTI work—including our Quality by Design and Patients Groups and Clinical Trials recommendations—that emphasizes the involvement of many stakeholders, including patients and sites, in trial design.

CTTI and FDA Workshop Will Explore How Best to Include Patient Perspectives in Clinical Trials

Posted on by Lorri Bingham

CTTI will convene a public workshop, “Enhancing the Incorporation of Patient Perspectives in Clinical Trials” in collaboration with the FDA on Mon., March 18, from 9:00 a.m. to 5:00 p.m. at the Tommy Douglas Conference Center in Silver Spring, Md.

 

The workshop will seek ideas for best practices and key considerations for enhancing the incorporation of patient perspectives on clinical trial access, design, conduct, and post-trial follow-up. It will also gather input from patients, caregivers, industry, academic researchers, and expert practitioners on the challenges and barriers to patient participation in clinical trials. CTTI and the FDA are especially interested in the perspectives of patients, caregivers, researchers, and others who have participated in clinical trials and are willing to share their experiences.

 

This workshop meets an FDA commitment that is part of the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI). After the event, a published report on proceedings and recommendations from the workshop will be made publicly available.

 

Register for the workshop by March 11. Registration is free and based on space availability, with priority given to early registrants. If you are unable to attend the workshop in person, you can watch the live webcast.

 

Don’t miss this opportunity to make your voice heard and shape the future of clinical research!

CTTI to Launch Recommendations for Engaging Patient and Site Perspectives in Mobile Clinical Trials

Posted on by Lorri Bingham

CTTI will host a public webinar on Thurs., Feb. 21, to announce new recommendations and resources for incorporating patient and site perspectives when planning and conducting mobile clinical trials.

“Acceptance and adoption by key stakeholders is critical to the widespread use of mobile technologies in clinical trials,” said CTTI Executive Director Pamela Tenaerts. “However, very little was known about patient and sites’ perspectives until our work shed light on what they see as significant benefits and barriers. Our new recommendations account for these perspectives and provide a valuable resource for optimally deploying mobile clinical trials.

“Further, they build on previous CTTI work—including our Quality by Design and Patient Groups and Clinical Trials recommendations—that emphasizes the involvement of many stakeholders, including patients and sites, in trial design. Engaging these groups early and often is the key to running better trials.”

CTTI conducted surveys and in-depth interviews to better understand the perceptions of patients and clinical investigators, and convened experts and leaders across the clinical trials enterprise to develop actionable recommendations and resources.

The resulting recommendations are designed to assist research sponsors in:

  • Engaging patient and site perspectives in planning clinical trials using mobile technologies, including protocol design, technology selection, and pilot testing
  • Maximizing value and minimizing burden for study participants, including setting patient expectations, protecting privacy, returning individual data, enhancing patient-site interactions, and providing technical support
  • Addressing challenges for investigative sites, from contracting and budgeting to evaluating site readiness and implementing effective and streamlined training

This is the final of four sets of recommendations CTTI has released as part of its Mobile Clinical Trials (MCT) Program. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies and, in 2018, it unveiled new solutions for using mobile technologies for data capture in clinical trials, and recommendations for planning and conducting decentralized clinical trials.

The free webinar will begin at noon ET and will be led by patient advocate Cindy Geoghegan and Virginia Nido of Genentech, a member of the Roche Group.

Now Available: Summary of the Patient Engagement Collaborative Inaugural Meeting

Posted on by Lorri Bingham

The FDA, in collaboration with CTTI, convened the inaugural meeting of the newly formed Patient Engagement Collaborative (PEC) in August at the FDA’s White Oak Campus in Silver Spring, Md. A summary of the meeting is now available.

 

The PEC is a joint initiative of the FDA and CTTI. Its 16 members, selected from nearly 200 patients and advocates, are helping expand the FDA’s efforts to achieve meaningful patient engagement in medical product development and other regulatory discussions. This effort is facilitated by provisions in the 21st Century Cures Act of 2016 and the Food and Drug Administration Reauthorization Act of 2017.

 

The objectives of the PEC’s first meeting were to agree on the group’s vision and goals and to discuss opportunities to enhance communications and resources for interactions between the FDA and the patient community. Among the meeting’s key takeaways, the PEC agreed that patient engagement can inform the research and development continuum from beginning to end, and that a systematic approach by the FDA to including the patient voice in the regulatory decision-making process will be important.

 

The PEC will meet several times a year, both in-person and by teleconference, to continue to discuss how to enhance patient engagement in regulatory decision-making.

 

CTTI Article Finds that Patients and IRBs are Amenable to Early Enrollment Strategy

Posted on by Lorri Bingham

A CTTI article recently published in JAMA Network Open shows that an early enrollment strategy for research on healthcare-associated pneumonia is acceptable to patients, investigators, and institutional review boards (IRBs). This strategy has the potential to speed enrollment in trials for critical new antibiotic therapies by allowing patients to be approached and consented to before being diagnosed with pneumonia.

Through its ABDD HABP/VABP Studies work, CTTI conducted qualitative interviews with 52 stakeholders—including patients at risk for pneumonia, caregivers, study investigators and coordinators, and IRB representatives—as part of formative research to assess the acceptability of the approach.

The study found that patients and caregivers had no concerns about patients being approached early and having their records monitored before they developed pneumonia. They believed that patients would be able to understand consent information before diagnosis, and shared their preferences for opt-out procedures.

IRB representatives were also supportive of an early enrollment strategy, and investigators and study coordinators indicated that the approach would not be burdensome.

CTTI to Support NIH Workgroup in Developing Evaluation Plan for Single IRB Policy

Posted on by Lorri Bingham

The NIH has selected CTTI to support a workgroup that will develop a comprehensive plan for assessing the NIH’s new single institutional review board (sIRB) policy. The policy, which became effective in January, requires U.S. sites participating in nonexempt multicenter human subjects research funded by the NIH to use a sIRB for ethical review, with the goal of improving the quality and efficiency of clinical research.

 

“For nearly a decade, CTTI has championed the adoption of sIRBs for multicenter clinical trials,” said Pamela Tenaerts, executive director at CTTI. “We are excited to use our expertise to craft an evaluation plan for the NIH policy, and to design standard evaluation methods that can be used by academic organizations, research sponsors, and others who are interested in implementing sIRBs.”

 

Sites in multicenter clinical trials have typically relied on their own IRBs to conduct required ethical reviews, often leading to needless repetition across sites. The goal of the NIH’s new sIRB policy is to enhance and streamline the review process for multicenter studies so that research can proceed as quickly as possible and research oversight may be improved.

 

CTTI has developed a number of recommendations and resources to support sIRB adoption, and the NIH referenced CTTI’s work in a 2014 draft policy recommending the use of sIRBs. Currently, CTTI is gathering information from sponsors, investigators, IRB members, and research and regulatory coordinators to determine actions that the NIH, the FDA, and the Office for Human Research Protections can take to help the research community adopt sIRB review.

CTTI Receives Innovations in Regulatory Science Award from Reagan-Udall Foundation

Posted on by Lorri Bingham

The Reagan-Udall Foundation for the FDA presented CTTI with the Innovations in Regulatory Science Award on Tues., Dec. 4, in recognition of its achievements and continued contributions to regulatory science. CTTI was one of three recipients of the annual award.

CTTI Wins Reagan-Udall Award

“This great honor caps off a momentous year for CTTI,” said Pamela Tenaerts, CTTI executive director. “We celebrated our 10-year anniversary at the beginning of 2018, so this award affirms that our efforts over the last decade have led to meaningful positive change in the quality and efficiency of clinical research.”

 

The Reagan-Udall Foundation for the FDA is an independent nonprofit organization created by Congress for the purpose of advancing regulatory science that is critical to the FDA’s mission.

 

“We are pleased to give CTTI proper recognition for advancing public health by streamlining and improving clinical research,” said Garry Neil, MD, awards committee chair and chief scientific officer for Aevi Genomic Medicine. “CTTI not only identifies the most critical areas that need to be addressed in order to achieve better and more efficient clinical trials—it also provides actionable road maps to help stakeholders realize this vision.”

 

Many agencies and organizations have applied CTTI’s more than 20 existing recommendations and associated resources to make better clinical trials a reality. A few examples include:

  • CTTI’s Quality by Design work has been cited in FDA and EMA guidance and incorporated into Good Clinical Practice (GCP) guidelines.
  • Its Single IRB recommendations and resources have been used by organizations such as Northwell Health and the National Institute of Neurological Disorders and Stroke.
  • The Duke Clinical Research Institute (DCRI) developed a new program for engaging patients in the research process based on CTTI’s Patient Groups & Clinical Trials work.

CTTI joined other awardees Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence (OCE), and Robert O’Neill, PhD, former senior statistical advisor in the Office of Translational Sciences at the FDA’s Center for Drug Evaluation and Research.

The awards dinner took place at the Kaiser Permanente Center for Total Health in Washington, D.C.

Webinar Now Available: CTTI’s New Recommendations to Improve Investigator Qualification

Posted on by Lorri Bingham

During a public webinar on Thurs., Nov. 15, CTTI released new recommendations that propose a fresh approach for investigator qualification. The webinar, now available online, explored how these new recommendations can move qualification activities beyond repetitive one-size-fits-all training to include individual experience and protocol-specific preparation.

Investigator Qualification Recommendations

While current FDA regulations state that sponsors and their delegates are responsible for selecting qualified investigators, no guidelines exist for how to meet this requirement. Good Clinical Practice (GCP) training is widely used as the industry standard, but there is little evidence that it sufficiently qualifies investigators and their delegates to conduct quality clinical trials.

 

CTTI convened a team of experts and leaders across the clinical trials enterprise to develop new recommendations and resources that can help to implement a more efficient and effective qualification process. CTTI’s recommended approach recognizes previous training and experience, identifies gaps in knowledge and skills, and improves understanding of how to apply GCP principles to the conduct of clinical trials.

 

“If we are to support successful clinical trial conduct, we can’t look at training in isolation,” said Sabrina Comic-Savic of The Medicines Company, who presented during the webinar. “These recommendations come as part of an overall approach that CTTI is taking to improve the whole ecosystem where sites operate in order to support the quality conduct of clinical trials.”

 

The webinar also featured Jimmy Bechtel of the Society for Clinical Research Sites (SCRS) and Kate Haratonik of Genentech—a member of the Roche Group.

Recommendations Now Available for Improving Investigator Qualification

Posted on by Lorri Bingham

CTTI released new recommendations proposing a new approach for investigator qualification today during a public webinar. This approach goes beyond repetitive one-size-fits-all training and includes individual experience and protocol-specific preparation.

 

Investigator Qualification Recommendations

While Good Clinical Practice (GCP) training is widely used as the industry standard for investigator qualification, there is little evidence that completion of GCP training alone sufficiently qualifies investigators and their delegates to conduct quality clinical trials. In fact, the most common deficiencies noted during investigator inspections are often directly related to GCP principles. Furthermore, redundant GCP training creates an unnecessary burden for site teams and limits the opportunity for more valuable, protocol-specific learning and preparation.

 

To address this challenge, CTTI convened a team of experts and leaders across the clinical trials enterprise to develop new recommendations and resources that can help in implementing a more efficient and effective means of qualification. CTTI’s recommended approach recognizes previous training and experience, identifies gaps in knowledge and skills, and improves understanding of how to apply GCP principles to the conduct of clinical trials.

 

By implementing CTTI’s recommendations, stakeholders could improve the execution of study protocols and ultimately the overall quality of trials. The recommendations can also help stakeholders create a culture of collaboration and provide ongoing support through formalized mentorship and knowledge-sharing platforms.

 

Recognizing that successful clinical trials require not only qualified site teams but also well-designed protocols and robust site-based infrastructure, CTTI encourages site teams to use these new recommendations in conjunction with its Quality by Design recommendations on protocol development and Investigator Community recommendations for a holistic approach to conducting quality clinical trials.