Updates on pediatric trials, including news from a recent study.
The market for prescription pediatric drugs worldwide is expected to approach $43 million by 2011, according to Kalorama Information Research. There are approximately 2.5 billion children in the world, representing 40% of the population. Most drugs in development for children are in the areas of genetic diseases including cystic fibrosis, Gaucher disease, and hemophilia; and infectious diseases, including head lice, influenza, and RSV.
Medicines in Development for Children
While the drugs in development for pediatrics cover a horizontal therapeutic market, conducting trials in children is not a one-size-fits -all enterprise.
In November, Peter Joiner, Chief Executive Officer of Madeira Therapeutics, which conducts pediatric trials, told Applied Clinical Trials in a podcast that both children and parents need to be comfortable in order to participate in a pediatric trial. So investigative sites need to accommodate the family and be "kid friendly." Strategies include bright colors, friendly people, flexible scheduling, and an overall welcoming environment.
However, a recent study appearing in Pediatrics (March 29, 125: e876-e883) and covered as a news item on Medscape, shows issues specific to the pediatric consent process. This study indicated that a full 86% of children participating in oncology trials did not understand what their doctor was saying to them about the trial, and that the decision was more in the hands of their parents and doctors. The authors of the study said that the findings mean that enhanced communication between the pediatric oncologists and the families would help improve the assent/consent process. Felix Khin-Maung-Gyi, Chief Executive Officer of Chesapeake Research Review, told us that the study shows "we have a long way to go in terms of the general populations understanding of research and the role of participation."
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.