Difficulties and Trends in Pediatric Trials

Clinical Trials Transformation Initiative


The public-private partnership CTTI (Clinical Trials Transformation Initiative) in its recent release has addressed the difficulties encountered by sponsors in patient recruitment and conducting pediatric clinical trials for antibiotics. These difficulties result in new drugs often being used in the treatment of children. In many cases, the relevant pediatric labeling of a new antibiotic may arrive five plus years after it has been approved for treatment of adults. In order to help sponsors improve this situation and deliver new products to pediatric populations as soon as possible, CTTI released a set of recommendations.

Thus, CTTI recommends sponsors to get approval from FDA on their initial pediatric research plan in Phase II of their adult clinical trial. Besides, when appropriate, pharma should consider conducting PK (pharmacokinetic) studies in children simultaneously with Phase III of adult trials.

CTTI also makes a number of recommendations regarding protocol designs aimed towards:

  • broadening the criteria of eligibility for pediatric clinical studies;
  • minimizing the burden of medical research for pediatric patients and neonates;
  • providing additional training to sites on the subject of informed consent practices in clinical trials.

 

Popularity of Adaptive Design Trials

Due to their flexibility and efficiency, adaptive design clinical trials are growing in popularity among new drug developers, yet a lot of pharma companies still choose to stick to non-adaptive trials. For instance, according to a recent investigation, 76% of all surveyed trial sponsor teams plan and conduct adaptive clinical trials, while 82 % of them choose to plan and conduct non-adaptive, traditional studies.

According to a research conducted by Cutting Edge Information, clinical development teams are more likely to participate in adaptive studies’ trial planning and execution than larger clinical operations groups. Among surveyed pharma companies, 59% reported their clinical operation groups taking part in trial planning and conducting for non-adaptive studies, while 65% of drug manufacturers said their clinical operations teams plan and/or execute adaptive studies. However, as suggested by interviewed executives, the level of clinical staff’s familiarity with adaptive trial methodologies may vary per company. Still, even if the staff does have that knowledge, they will hardly be able to use it if the organization does not sufficiently support adaptive trials.

With this respect, collaboration with smaller CROs – especially those operating in such countries as Russia – may prove to be highly efficient. The country allows for vast opportunities of fast patient recruitment to conduct clinical trials in a wide range of therapeutic areas including orphan diseases. One of such CROs, Atlant Clinical, boasts rich experience in conducting clinical trials for a number of therapeutic areas as well as for orphan diseases. Another advantage of such smaller CROs with international operations is their strong, low turnover teams of experts and CRAs, like the one at Atlant Clinical.

 

Growth of mHealth Market

The mHealth market is expected to grow dramatically according to the Global mHealth Market Report Forecast. In order to provide accurate information about revenue forecasts and growth trends, the report focuses on the key factors that restrain and drive this market, along with giving an in-depth analysis of the geographic regions, market share, and segmentation.

During the forecast period of 2014–2022 the report predicts impressive growth of the global mHealth market, with the increasing number of aging population and chronic disease instances being some of its major driving factors. Another incentive for this market is the growth of smartphone penetration worldwide. New business opportunities on the global scale on this market can be enhanced by increased research and development activities as well as the growth of investments in emerging markets made by the top industry players.

In the mentioned report, the global mHealth market is classified by:

  • services – with subsections of patients’ solution services and healthcare strengthening systems;
  • types of applications – with segments for disease management, remote monitoring, wellness and fitness tools, medical reports,  and several other similar applications;
  • major geographic regions –  with Europe, North America, and Asia-Pacific being the biggest segments in this industry, and Asia-Pacific being also the strongest growing on the mHealth market.