Autism

AutismDuring the five years from 2009 to 2013 the Incidence rate of Autism Spectrum Disorder (ASD), according to the official statistics of the Ministry of Health of Ukraine, increased by 194%: from 0.55 to 1.61 per 100,000 children population.The  indicator of prime Morbidity in Ukraine is steadily increased during the past six years: 2007 – 28.2%; 2008 – 32.0%, 2009 – 27.2%, 2010 – 35%, 2011 – 21.2%, 2012 – 25.3%. The Prevalence rate of ASD in children population over the years has grown 2.84 times from 17.0 to 48.2 per 100,000 population. In spite of the significant increase, Prevalence rates of ASD in Ukraine remain significantly lower than in the United States and European countries.

Standardization of medical care

  • The Order of the MoH of Ukraine of 15.06.2015 # 341 “On approval and implementation of medical and technological documents on standardization of medical care in autism“.

Public medical organizations

  • Scientific-Practical Society of Neurologists, Psychiatrists, and Narcologists of Ukraine
  • All-Ukrainian public organization “All-Ukrainian Association of Children’s Psychiatrists”

Clinical trials including adults /in adults, adults & children/

  • Globally, 46 recruiting clinical trials for autism include 4 Phase I and 3 Phase IV trials.
  • World leaders: the USA – 31, France – 9, Canada – 4 recruiting trials.
  • CEE leaders: no recruiting trials.
  • Ukraine: no recruiting clinical trials. No international clinical trial experience for autism.

Clinical trials on medical devices

  • Globally, there are 8 recruiting clinical trials, including 1 Phase I trial in the USA
  • World leaders: the USA – 5, France- 2, Canada – 1 recruiting trial.
  • CEE leaders: no recruiting trials.

Clinical trials with stem cells

  • Globally, no recruiting clinical trials.

Clinical trials including children /pediatric, in children & adults/

  • Globally, 120 recruiting clinical trials for autism include 8 Phase I trials and 4 Phase IV trials.
  • World leaders: the USA – 91, France – 10, Canada – 5 recruiting trials.
  • CEE leaders: Bulgaria/Hungary/Poland/Romania/the Russian Federation/Ukraine – 1 recruiting trial.
  • Ukraine: 1 recruiting Phase III clinical trial. The total country’s international experience for autism includes 4 Phase II and III clinical trials on 10 clinical sites located in 9 cities: Kharkiv – 2, Ivano-Frankivsk/Kherson/Kyiv/Lviv/Odesa/Poltava/Ternopil/Vinnytsia – 1 clinical site.

Clinical trials on medical devices

  • Globally, there are 9 recruiting clinical trials, including 1 Phase I trial in the USA.
  • World leaders: the USA – 7, Canada – 2 recruiting trials.
  • CEE leaders: no recruiting trials.

Clinical trials with stem cells

  • Globally, 1 Phase I clinical trial is conducted in Mexico.

clinical trials for autism incl children in CEE

clinical trials for autism incl children in Ukraine


Non-interventional studies including adults /in adults, adults & children/

  • Globally, 29 recruiting observational studies for autism include 3 studies on medical devices.
  • World leaders: the USA – 17, France – 6, Taiwan – 4 recruiting studies.
  • CEE leaders: no recruiting studies.

Non-interventional studies including children /pediatric, in children & adults/

  • Globally, 44 recruiting observational studies for autism include 2 studies on medical devices (the USA).
  • World leaders: the USA – 26, France – 11, Taiwan – 3 recruiting studies.
  • CEE leaders: no recruiting studies.

NB! The cities located in the non-controlled territories of Ukraine are not included in the statistics!

Publications of

Sergii Gromov