CTTI News

CTTI Launches New Recommendations to Improve Qualification of Investigators

Posted on by Lorri Bingham

CTTI will release new recommendations that propose a new approach for investigator qualification during a public webinar on Thurs., Nov. 15. This approach goes beyond repetitive one-size-fits-all training and includes individual experience and protocol-specific preparation.

 

Current regulations from the U.S. Food and Drug Administration (FDA) require that sponsors and their delegates select qualified investigators. Good Clinical Practice (GCP) training is widely used as the industry standard for ensuring investigators are qualified, but there is little evidence that completion of GCP training alone sufficiently qualifies investigators and their delegates to conduct quality clinical trials.

 

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 to implement a more efficient and effective qualification process and determine whether a site team is a good fit for a particular protocol. 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 could also help create a culture of collaboration and provide ongoing support through formalized mentorship and knowledge-sharing platforms.

 

The webinar will begin at noon ET and will be led by Jimmy Bechtel of the Society for Clinical Research Sites (SCRS), Sabrina Comic-Savic of The Medicines Company, and Kate Haratonik of Genentech—a member of the Roche Group.

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.

Experts Explore Ways to Promote Use of Real-World Evidence in Clinical Trials: Latest CTTI Expert Meeting Summary Now

Posted on by Lorri Bingham

The use of real-world evidence (RWE)—derived from sources such as electronic health records (EHR) and claims data—has the potential to provide a more complete picture of patient experiences, reduce costs, and offer unique insights into important scientific questions. At the same time, there are relatively few examples to inform efforts to integrate RWE into clinical trials, as well as a lack of consensus among researchers about valid approaches for leveraging these data sources.

To address this issue, CTTI convened an expert meeting in June 2018 to discuss best practices and needed resources for advancing the use of RWE in randomized clinical trials. The meeting (see one-page summary) included investigators, patients, regulators, technology experts, sponsor representatives, and other groups.

While participants agreed that the use of RWE could be a major step forward in clinical trials, they stressed the importance of recognizing and planning for its limitations, including inconsistent data reliability and quality. They also agreed that direct interaction with participants and the integration of various real-world data sources is critical for improving the depth and breadth of available data.

As the next step in its Real-World Evidence work, CTTI will develop recommendations and resources for incorporating RWE into randomized trials for regulatory submission.

CTTI Article Outlines Recommendations for Pregnancy Testing in Clinical Trials

Posted on by Lorri Bingham

Most clinical trials exclude pregnant women in order to minimize risk to the embryo or fetus. However, there are currently no specific guidelines for how pregnancy testing should be conducted for female trial participants of reproductive potential, nor how risks should be clearly communicated with them.

In a recent article in PLOS ONE, CTTI shares recommendations developed by experts in academia, industry, and regulatory agencies on pregnancy testing in clinical research. They include the following:

  • The study protocol should clearly state the rationale for pregnancy testing and the plan for handling positive and indeterminate tests.
  • Investigators should assess the balance of the advantages and burdens of the pregnancy testing plan, as well as and evaluate participant burdens regarding the likelihood of false-negative and false-positive results.
  • Participant-administered home pregnancy testing should be avoided in clinical trials.
  • The consent process should describe what is known about the study intervention’s potential risk to an embryo or fetus and the limitations and consequences of pregnancy testing.

CTTI also developed an online tool to estimate the potential outcomes of different pregnancy testing strategies in the proposed trial population. Together, these resources aim to help research sponsors, investigators, and institutional review boards create and review pregnancy testing plans, in an effort to conduct safer, more efficient clinical trials.

CTTI Shares Solutions for Using Mobile Tech in Clinical Trials in Upcoming FierceMarket Webinar

Posted on by Lorri Bingham

CTTI will share its new recommendations for incorporating mobile technology into clinical trials during an upcoming FierceMarkets webinar on Thurs., Oct. 11, at 2:00 p.m. ET. During this webinar, experts will explain how and when to use mobile devices and applications to capture more informative real-world data from patients, reduce barriers to trial participation, lower costs, and speed the timelines associated with conducting clinical trials.

 

These evidence-based solutions—jointly developed by regulators, sponsors, clinicians, technology experts, data scientists, and patients—provide practical guidance for:

  • Selecting appropriate mobile technologies;
  • Collecting, analyzing, and managing the data they generate;
  • Optimizing protocol design when these technologies are used for data capture; and
  • Preparing for FDA submission and inspection.

This action-oriented webinar, sponsored by Amazon Web Services, will describe in detail the information that investigators, sponsors, and service providers need to meet technical requirements, support collaborations, and understand each other’s needs and expectations—providing a pathway forward to make the use of mobile technologies in clinical trials a reality.

 

Speakers will include:

  • Linda Ricci (FDA/CDRH)  
  • Abby Bronson (Parent Project Muscular Dystrophy)
  • Ray Dorsey (University of Rochester)
  • Lita Sands (Amazon Web Services, Life Sciences)

Register to attend the webinar.

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.

Special Launch Event Recap: Using Mobile Technologies for Data Collection in Clinical Research

Posted on by Lorri Bingham

Experts Unveil New CTTI Recommendations and Resources at FDA’s White Oak Campus

During a daylong launch event at the U.S. Food and Drug Administration’s (FDA) White Oak Campus, more than 100 people—along with hundreds of virtual attendees—learned about CTTI’s newly release recommendations and resources for the use of mobile technologies in clinical trials.

The evidence-based recommendations and resources outline best practices for the use of mobile devices and applications to capture objective data—an approach that has the potential to increase the quality and efficiency of clinical trials.

More than 30 technology and clinical trials experts participated in sessions offering practical guidance, from selecting a mobile technology through to preparing for FDA submission and inspection. The event concluded with a lively panel on “The Future of Mobile Technologies in Clinical Trials,” where five leaders shared valuable reflections and predictions:

 

“A lot of what was discussed today is very much in line with the EMA’s position—the ‘rules’ are the same with data from mobile clinical trials and traditional trials, patient input is critical, and regulators should be engaged from the start of, and throughout a trial.” – Francesca Cerreta, European Medicines Agency

“One of the things I’m most excited about is that mobile technologies bring studies to participants, versus participants having to come to studies. And there’s opportunity to gather more pre- and post-intervention information than ever before.” – Ray Dorsey, University of Rochester

 

“There is a lot of interest in using mobile technologies in clinical trials and their potential to improve the quality and efficiency of clinical trials. This meeting is another step forward in exploring ways to incorporate mobile technologies into regulated clinical trials. I’m very encouraged by the sense of optimism from the many different sectors represented here today.” – Leonard Sacks, FDA

Pat Furlong, Parent Project Muscular Dystrophy, and John Hubbard, Genstar Capital, also joined Cerreta, Dorsey, and Sacks on the panel. They noted that CTTI’s new recommendations open the door to new opportunies for clinical tirals including improved patient engagement, better quality of data, and lower costs.

CTTI Unveils Recommendations for Using Mobile Technologies in Clinical Research

Posted on by Lorri Bingham

New Recommendations and Resources Provide Road Map for Using Mobile Technologies for Data Capture in Clinical Research

 

In a special event today at the U.S. Food and Drug Administration’s (FDA) White Oak Campus, CTTI unveiled new recommendations for the use of mobile technologies in clinical research. The evidence-based recommendations and resources address an unmet need by outlining best practices for the use of mobile devices and applications to capture objective data—an approach that has the potential to increase the quality and efficiency of clinical trials.

 

“The clinical research community has long discussed an exciting future of using mobile technologies to collect objective, reliable data in clinical trials,” said CTTI Executive Director Pamela Tenaerts. “Today, we are excited to start making this vision a reality—sharing recommendations for capturing more informative real-world data from patients, reducing barriers to trial participation, and lowering costs associated with conducting clinical trials.”

 

The full set of recommendations and resources includes case examples and decision tools that offer practical guidance for:

 

  • Selecting mobile technologies for data capture that are appropriate to the trial.
  • Capturing complete, attributable, and high-quality data.
  • Managing the data generated by mobile technologies—including safety considerations, data integrity, and security issues.
  • Designing and executing a protocol that uses mobile technologies for data capture.
  • Preparing for FDA submission and inspection.

 

This is the second set of recommendations from CTTI’s Mobile Clinical Trials Program for FDA-regulated trials. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies. Later this year, recommendations will be released addressing patients’ and investigators’ needs regarding the use of mobile technologies in clinical trials and overcoming challenges to conducting decentralized trials in the U.S.

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.

Watch Live from FDA’s White Oak Campus: CTTI Unveils Mobile Technologies Recommendations

Posted on by Lorri Bingham

Are you interested in transforming clinical trials by using mobile technologies for data capture? A clear road map for making this vision a reality is now here.

 

Watch live as leaders in clinical trials and mobile technologies unveil CTTI’s new Mobile Technologies recommendations from the U.S. Food and Drug Administration’s (FDA) White Oak Campus. Throughout the day, attendees will hear insights and practical guidance for:

 

  • Selecting mobile technologies for data capture that are appropriate to the trial.
  • Capturing complete, attributable, and high-quality data.
  • Managing the data generated by mobile technologies—including safety considerations, data integrity, and security issues.
  • Designing and executing a protocol that uses mobile technologies for data capture.
  • Preparing for FDA submission and inspection.

ADD TO CALENDAR

 

The event will culminate with an engaging panel discussion on the future of mobile technologies in clinical trials. Panelists will include Francesca Cerreta of the European Medicines Agency; Ray Dorsey of the University of Rochester Medical Center; Pat Furlong of Parent Project Muscular Dystrophy; John Hubbard of Genstar Capital; and Leonard Sacks of the FDA.