Clinical News Roundup: CTTI Issues Recommendations For Pediatric Trials

By Ed Miseta, Chief Editor, Clinical Leader

The Clinical Trials Transformation Initiative (CTTI) has released a set of recommendations it says will improve the use of antibiotics in children. The public-private partnership aimed at improving the quality and efficacy of clinical trials believes challenges in enrolling and completing pediatric clinical trials for antibiotics leads to a situation where such drugs are used in children despite lacking adequate labeling for pediatric populations. Furthermore, CTTI says that in many cases, pediatric labeling often comes five or more years after new antibiotics are approved for adult populations.

Specifically, CTTI recommends sponsors take action to improve pediatric antibiotic use by proactively engaging with regulators and making study design considerations early on in drug development. First, CTTI says pharma companies should align their studies with international regulators, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), in order to support coordinated submissions across different regions.

As early as possible, CTTI says sponsors should get input from FDA on their initial pediatric investigation plan as early as during adult Phase II trials. Additionally, CTTI says drug makers should consider conducting pediatric pharmacokinetic (PK) studies in children "concurrently with adult Phase III trials when appropriate."

Other recommendations include considerations for protocol designs to minimize the burden of the studies for pediatric patients and neonates, broadening eligibility criteria for pediatric studies and providing trial site staff with additional training on informed consent practices for such studies.

China Works To Reduce Trial Backlog

China Food and Drug Administration (CFDA) is facing increasing pressure as a backlog of pharmaceutical marketing and clinical trial applications grow, though trial standards there are approaching those of international standards, according to a perspective published in Nature Reviews Clinical Oncology on Tuesday.

At least part of the problem stems from the fact that CFDA uses “an overly strict approach” for approving clinical trial applications, which contrasts with an “overly lax approach” to approving marketing applications, the authors say, noting that the policies have resulted in a “notable widening of the gap between domestic and international clinical research, resulting in China falling many years behind other countries in terms of the approval of new drugs.

“A severe backlog of pending approval decisions has accumulated for novel agents,” the authors, two of whom work for CFDA's Center for Drug Evaluation (CDE), note. “Furthermore, vast numbers of generic drugs remain on the waiting list for approval, owing to delays in examination and approval of each case by the CFDA. This backlog arose, in part, from a lack of trained staff.”

In 2015, more than 21,000 applications awaited review by the CDE, most of which were for generic drugs. For clinical trials, the article says that between 2013 and 2015, the average delay for an application to register a clinical trial of an innovative drug was 14 months.

Percentage Of Clinical Development Teams Involved in Adaptive Design Varies

Although adaptive design clinical trials are a trending practice for developing new drugs, pharmaceutical companies still pursue plenty of non-adaptive trials. In fact, 76 percent of clinical development teams at surveyed drug manufacturers in a recent study plan and execute adaptive studies, while a higher percentage of these teams, 82 percent, plan and execute traditional, non-adaptive clinical trials.

Cutting Edge Information’s study, Adaptive Design Clinical Trials: Strategically Modify Traditional Methodologies to Support Efficient Clinical Operations, found the broader clinical operations groups were not as likely to be involved with trial planning and execution compared to clinical development teams. In fact, only 65 percent of surveyed companies reported that their pharmaceutical clinical operations groups plan or execute adaptive studies. Unlike clinical development teams, however, the data show that only 59 percent of surveyed drug manufacturers reported that their clinical operations teams impact trial planning and execution for non-adaptive studies.

“Often, companies involve similar groups in both adaptive and non-adaptive studies but leverage individual expertise in different ways,” says Sarah Ray, senior research analyst at Cutting Edge Information. “However, the contributions of different subteams do not change dramatically from non-adaptive to adaptive studies.”

Interviewed executives observe that clinical staff at all companies may have varying levels of familiarity with adaptive trial methodologies. However, their ability to use that knowledge depends on the degree to which organizations support their adaptive trials.

Aging Population Set To Grow mHealth Market

According to the report, Global mHealth Market Report By Services, Applications, End-Users, and Geography Report Forecast - 2014 to 2022, the market for mHealth is expected to witness impressive growth. The global mHealth market report focuses on the key driving and restraining factors for this market to offer accurate information about the growth trends and revenue forecasts. It also provides in-depth analysis of the market share, geographic regions, and detailed segmentation.

According to the mHealth market report, the global market is set to witness impressive growth during the forecast period. The increasing aging population is one of the major driving factors for this market. The report suggests that growth in smartphone penetration around the world is also expected to be a major driving factor for this market. The rise in the instances of chronic diseases and advancing technologies are also some of the significant driving factors for this market. According to the report, growth in the research and development activities from the top market players and increased investments across the emerging market segments are also expected to create business opportunities in this market on the global scale.

The report segments the global mHealth market by the types of applications, services, and the major geographic regions. The main application segments in the market include disease management, general wellness and fitness tools, remote monitoring, medical records, and such other applications. The service segment of the market is sub-segmented into healthcare strengthening systems and patients’ solution services. Both these segmented are sub-categorized further for a granular understanding of the industry trends. The major geographic segments in the market include Europe, Asia-Pacific, North America and the rest of the world. According to the mHealth market share analysis, North America is set to dominate the global market. Asia-Pacific region is expected to emerge as the strongest-growing segment in the market.

The key players highlighted in this mHealth market report include AT&T, Inc., Cerner Corporation, Apple, Inc., Alcatel-lucent, Diversinet Corp. (IMS Health), Airstrip Technologies, Inc., Koninklijke Philips N.V., Symantec Corporation, SoftServe, Inc., and Vodafone Group, Plc..

Merck Leads Alliance for Patient-Centered Cancer Care Access

The Merck Foundation has selected six health systems to form the Alliance to Advance Patient-Centered Cancer Care, issuing a total of $15 million in grants over five years to improve patient access to cancer care in underserved populations. According to Merck leaders, these awards will foster innovative approaches to delivering patient-centered cancer care, helping to improve quality of life and treatment access for the millions of patients diagnosed with cancer annually.

“With 1.7 million Americans newly diagnosed with cancer each year, there is a great need to improve the quality and delivery of patient-centered care to help address the significant challenges of those facing this diagnosis,” says Julie L. Gerberding, chief patient officer at Merck and CEO at the Merck Foundation. “These superb program sites and the National Program Office should accelerate identification and uptake of innovations that benefit patients, improve health communications, and enhance the overall coordination of care.”

The grant winners are Grady Health System, Johns Hopkins University, Massachusetts General Hospital, Northwestern University, Ohio State University, and the University of Arizona.  Merck has also selected the University of Michigan School of Nursing as the Alliance’s National Program Office. Selection criteria included organizational leadership, technical advances, and overall commitment to patient-centered care, the company said.