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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.