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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.