In a nearly 3,700 word missive by Scott Gottlieb, posted on August 29, 2018, the FDA commissioner attempts to bring some clarity to efforts by the agency to bring more innovation into the drug development process. Noting FDA’s goal of ensuring the right drug or device is delivered to the right patient at the right time, Gottlieb states the vision is moving closer to reality with innovative new products becoming available to pharma companies and its researchers.
Source: Clinical Leader
Our longstanding goal for medical care is to ensure that the right drug or device is delivered to the right patient at the right time. This vision is increasingly possible with the innovative products that are becoming available. Many of these opportunities are enabled by new technology platforms such as digital health, targeted medicines, and regenerative medicine, including cell and gene therapies. These new technologies offer transformative opportunities. But they also challenge the U.S. Food and Drug Administration (FDA) to modernize its approach to evaluating new innovations. In many cases, we’ve had to refashion our regulatory approach to create more modern platforms that are better suited to the efficient evaluation of these advances.
Source: FDA Voice
The clinical research community has long shared an exciting vision of using mobile technologies to collect objective, reliable data in clinical trials. Mobile technologies have the potential to capture more informative real-world data from patients, reduce barriers to trial participation, and lower the costs associated with conducting clinical trials. However, technical, clinical, operational and regulatory challenges have been barriers to widespread adoption of mobile technologies in regulated clinical trials – until now.
CTTI’s latest recommendations will help researchers deploy mobile technologies in clinical trials and “pave the way for improving how we develop medicines,” says Pfizer exec.
A dazzling new array of wearable and other mobile technologies can provide a more complete clinical trial picture, increase efficiency, and reduce the burden on patients, says Ken Skodacek, part of the U.S. Food and Drug Administration’s (FDA) Clinical Trials Program and Payer Communication Task Force at the Center for Devices and Radiological Health (CDRH). However, he also cautioned collecting too much data or flawed data will undermine all those potential gains.
Source: ACRP Blog
The advocates will work to enhance the US FDA’s understanding of how to best engage across patient communities, according to CTTI.
Much of the credit for improving the quality and efficiency of clinical trials in recent years goes to joint reform initiatives and greater disclosure of regulatory decisions and study results. Bioresearch sponsors are listing more studies on the ClinicalTrials.gov website, although the record is weaker for timely disclosure of research results for newly approved medical products. Under pressure to share more research data to avoid repeated errors and waste, biopharma companies also are providing qualified experts with access to confidential studies. And some sponsors are pledging to publish new research reports only in open access journals.
Source: Applied Clinical Trials
Last week CTTI and industry professionals gathered to celebrate the initiative's 10-year anniversary. To learn more about some of the key projects completed and challenges faced over the last decade - and what to expect from the next 10 years - we caught up with CTTI Executive Director Pamela Tenaerts.
Leaders of the biomedical research community recently celebrated progress over the last decade in devising strategies to improve the quality and efficiency of clinical trials. The 10th anniversary of the Clinical Trials Transformative Initiative (CTTI) last week provided an opportunity for FDA officials to join with study sponsors and research experts to examine the policy achievements and plans for future efforts of this multi-faceted initiative.
Source: Applied Clinical Trials
At a symposium marking the Clinical Trials Transformation Initiative’s 10th anniversary, industry and regulatory discussed the progress made by its Quality by Design initiative and the additional work needed to encourage the research industry to be more focused on trial quality and efficiency.
Nearly half of all so-called “one and done” principal investigators who retreat from clinical research after conducting a single study want back in if they can find resources and advice to help on their second attempt, according to findings from a new Clinical Trials Transformation Initiative (CTTI) survey and recommendations project.
Source: ACRP Blog
It can be seriously disruptive when the site investigator for your trial leaves or decides to step down, but new recommendations from the Clinical Trials Transformation Initiative (CTTI) aim to mitigate that risk.
CTTI has released new recommendations that can be implemented by sponsors, CROs, and others, in order to decrease the number of ‘one and done’ clinical trial site investigators.
CTTI's new evidence-based recommendations provide a standard way to plan for and make decisions about pregnancy testing in clinical trials, and also improve communications and transparency with trial participants," Calvert explained.
"Clinical drug development is generally an inefficient process. The cost of conducting clinical trials drives R&D spending, and much of the elaborate superstructure involved needs to be reassessed and could be pared down without harming participants. The EMA actively promotes better design and more efficient trial conduct and supports the efforts of the Clinical Trials Transformation Initiative, created by the Food and Drug Administration and Duke University, and other efforts to streamline trials."
"Some of the first formal efforts to outline the science of patient input borrow, from software development, the use of frameworks to provide a logical structure for organizing information, identifying sources of the information, and suggesting ways it might be used and viewed by distinct parties… The Clinical Trials Transformation Initiative (CTTI) created perhaps the most recognizable tool, and its work has become a guidepost.”
For more information of CTTI's Patient Groups & Clinical Trials Project, click here.
Source: Science Translational Medicine
CTTI is featured as a driver of action-oriented solutions in this Wall Street Journal article that explores the critical need for improved patient recruitment rates. “We want to create trials that everyone involved can champion, and that doctors can feel good about engaging their patients in,” says Jamie Roberts, senior clinical project manager for the CTTI Recruitment Project.
Source: Wall Street Journal
CTTI participated in MediaplanetUSA’s Clinical Trials campaign, where associations and industry experts came together to spotlight the need for more clinical trial participants, to change the public perception and showcase why clinical trials are so important in helping those in need. The campaign was distributed within the centerfold of USA Today on December 18, 2015.
"In recent years there has been an increasing focus on patient engagement, centering on new opportunities for FDA to incorporate the patient perspective into its regulatory decision making. These discussions have resulted in Congress and FDA establishing new policies and programs... However, the public dialogue has largely left out the opportunities for meaningful engagement between patients and research sponsors (academia and the medical product developers). That changed in 2014, when Clinical Trials Transformation Initiative (CTTI) initiated the Patient Groups & Clinical Trials (PGCT) Project. "
Source: FDA Law Blog
On CTTI's Quality by Design work: “Those principles were tested and refined through a series of workshops,” says Glessner. “I can’t speak highly enough about the power of those workshops. They actually involved putting materials into individual’s hands and testing them. Then after a period of time CTTI wanted to know whether the workshops were effective, and to determine that approximately 20 individuals were interviewed. These were deep, detailed interviews asking participants what they were able to take away from the workshops, what they were able to apply in their own businesses, and what problems continued to be a struggle for them.”
Source: Clinical Leader
"In the words of Doctor Hans-Georg Eichler, Senior Medical Officer at the European Medicines Agency (EMA): 'We understand that trials as we do them today are not sustainable, they're expensive, they're inefficient, they take too long-patients complain why they have to wait so long for new medicines-and they're very bureaucratic.' EMA is part of the Clinical Trials Transformation Initiative (CTTI), established by the FDA and Duke University (Durham, USA), that aims to improve the quality and efficiency of trials."
Source: Mobile Health Global
“We've been working [for] the past many years on trying to reform the clinical trial system in both the United States and worldwide because clinical trials are very resource wasteful in a sense… We're also working with the… Clinical Trials Transformation Initiative, to bite off different pieces of the current trial conduct and design and re-design those, and I think we've made significant progress there.”
“We think that there is a lot of merit in supporting improvements in the clinical trial infrastructure itself. The Clinical Trials Transformation Initiative has contributed so much in terms of innovative trial design, as it is working on establishing centralized IRBs for multicentered trials, which is an important advancement.”
Source: Applied Clinical Trials
“FDA’s active participation in partnerships like the Biomarkers Consortium, the Critical Path Initiative, and the Clinical Trials Transformation Initiative is critically important. What has the agency learned from these partnerships, and have officials taken necessary steps to implement new data as broadly and consistently as possible? Much progress remains until efficient trials with flexible designs aided by innovative technologies are no longer the exception to the rule.”
Source: 21st Century Cures