Patient Engagement

CTTI Launches New Tool to Help Identify High-Value Patient Engagement Opportunities

Posted on by Lorri Bingham

As part of its commitment to promote the engagement of patients as equal partners in clinical research, CTTI launched a new tool today at the 2019 DIA Global Annual Meeting that will help sponsors and patient groups identify high-value opportunities to collaborate.

The free web-based tool walks users through a three-step prioritization process:

  1. Identify relevant engagement activities. Patient groups and sponsors first identify all potential opportunities to collaborate, working from a comprehensive list developed by CTTI and adding their own fit-for-purpose activities.
  2. Evaluate benefits and investments. After reviewing factors identified by CTTI research, sponsors and patient groups rate the benefit and investment of each activity.
  3. Identify mutually beneficial activities. Research sponsors and patient groups compare and discuss their respective priorities and decide on opportunities that are of high value for each. A benefit/investment matrix helps visualize priorities and support discussion.

The tool is part of CTTI’s Patient Groups & Clinical Trials work, which encourages sponsors, investigators, and other stakeholders to engage with patient groups early and often for better and more efficient clinical trials.

“This new prioritization tool builds on the foundational work CTTI has already completed and ensures that collaboration is focused on areas where the greatest benefit can be achieved for everyone involved, given limited resources,” said CTTI Executive Director Pamela Tenaerts. “With an easy, three-step process, the tool helps create and identify high-value opportunities for patients and sponsors to engage in the clinical research enterprise.”

Linda Brennan, director of community partnerships at the Cystic Fibrosis Foundation, and Jaye Bea Smalley, director of patient advocacy and life cycle management for inflammation and immunology at Celgene Corporation, will publicly introduce the tool in the “Identifying High-Value Patient Engagement Opportunities: A Collaborative Three-Step Process for Sponsors and Patient Groups” DIA 2019 session at 8 a.m. PT.

Now Available: Summary of the March Patient Engagement Collaborative Meeting

Posted on by Lorri Bingham

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

The primary objective of the PEC’s most recent meeting was to discuss a “how-to guide” to help patients and patient groups navigate engaging with the FDA. Ideas for new resources included a patient ambassador training program and informational marketing campaigns to meet patients where they live and work.

The PEC, a joint initiative of the FDA and CTTI, has 16 members who were chosen from nearly 200 patients and patient advocates. The members’ discussions help to inform the FDA’s efforts to engage patients meaningfully 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.

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.

 

New CTTI Recommendations Offer Path Forward for Decentralized Clinical Trials

Posted on by Lorri Bingham

CTTI released new recommendations on overcoming the legal, regulatory, and practical hurdles for planning and conducting decentralized clinical trials (DCTs) today during the DPharm: Disruptive Innovations to Advance Clinical Trials conference in Boston, Mass.

 

DCTs, which are run through telemedicine and mobile health care providers, offer several potential advantages, such as faster recruitment, improved retention, greater control and convenience for participants, and increased participant diversity. CTTI’s evidence-based and practical recommendations address barriers—including varying state medical licensing laws and issues with the drug supply chain of custody—that could be hindering the widespread use of DCTs.

 

The recommendations also offer guidance on effective DCT protocol design, investigator delegation and oversight, use of mobile health care providers, and safety monitoring. A key concept within the recommendations is that DCTs do not have to be fully decentralized, but can incorporate various procedures and activities that are common in traditional studies.

 

This is the third set of recommendations from CTTI’s Mobile Clinical Trials Program for FDA-regulated trials, which aims to drive the adoption of mobile technologies in an effort to improve the efficiency and quality of clinical trials. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies and, in July, it unveiled new solutions for using mobile technologies for data capture in clinical trials. Recommendations addressing patient and investigator engagement regarding the use of mobile technologies in clinical trials will be released in early 2019.

CTTI Study Shows More Efforts Are Needed to Stimulate Pediatric Antibacterial and Antifungal Drug Trials

Posted on by Lorri Bingham

In an article recently published in Pediatrics, CTTI researchers assess the impact of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) on pediatric antibacterial and antifungal drug trials.

The study, which evaluated pediatric trials conducted between 2007 and 2017, found that nearly two-thirds of pediatric antibacterial and antifungal drug trials were conducted under BPCA or PREA. These trials were more likely to collect pharmacokinetic data and report results than non-BPCA/PREA trials.

However, the overall number of pediatric antibacterial and antifungal drug trials was low, representing less than 1 percent of pediatric trials overall. These trials also rarely enrolled infants up to 30 days old.

The findings show that, while federal legislation is likely having an impact on pediatric antibacterial and antifungal drug trials, more efforts are needed to stimulate these trials and improve the reporting of results.

This study was conducted as part of CTTI’s ABDD Peds Trials Project, which focuses on creating efficient, evidence-based processes to accelerate the development of safe and effective pediatric antibacterial drugs.

Sixteen Representatives Selected for the Patient Engagement Collaborative at FDA

Posted on by Lorri Bingham

CTTI and the FDA recently announced newly selected representatives for the Patient Engagement Collaborative (PEC), a joint endeavor announced in December 2017 to gather members of the patient community to discuss new ways for patients and the FDA to work together. These 16 representatives will meet with the FDA several times a year to discuss topics such as communication, transparency, and how patients can participate in the FDA’s regulatory discussions about medical products.

The representatives are:

  • Dawn Aldrich
  • Ronald Bartek
  • Karen Erickson
  • Jeffrey Goldstein
  • Anne Hall
  • Melissa Hogan
  • Elizabeth Joniak-Grant
  • Nancy Lenfestey
  • Isabelle Lousada
  • Stephanie Monroe
  • Lawrence “Rick” Phillips
  • Philip Posner
  • Lynne Quittell
  • Adrienne Shapiro
  • Theresa Strong
  • Dave White

The representatives were selected from nearly 200 nominations received in response to a Federal Register notice published in December 2017. The selection committee, which included patient advocates and staff from CTTI and the FDA, worked to identify representatives with diverse perspectives and experiences who could meaningfully contribute and express the patient voice.

“We are excited to welcome these experts to the PEC and are confident that they will make a significant contribution to advancing patient engagement in research and development,” said Pamela Tenaerts, MD, MBA, CTTI Executive Director. “This group will play a critical role in ensuring that every step of medical product development accounts for patients’ needs.”

The PEC was created as a response to public feedback the FDA requested on Section 1137, Patient Participation in Medical Product Discussions, of the Food and Drug Administration Safety and Innovation Act (FDASIA). One suggestion was to create an outside group to give input on patient engagement across the FDA.

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.