Author: Lorri Bingham

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.

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.