28.Nov.2011

OCT-Clinical trials in Central and Eastern Europe have completed a pilot clinical study at three sites in 60 patients

This was a clinical study in sore throat indication. Patients were enrolled in less than two months despite of the fact that this was not the season time.
Respiratory and otolaryngology diseases are quite wide-spread, with usual peaks in Autumn and Spring.

This was a clinical study in sore throat indication. Patients were enrolled in less than two months despite of the fact that this was not the season time.
Respiratory and otolaryngology diseases are quite wide-spread, with usual peaks in Autumn and Spring. URTI may be caused by viruses (influenza, adenoviruses, enteroviruses, parainfluenza, rhinoviruses, coronaviruses), bacteria (meningococcus, streptococcus), mycoplasma. An important factor in disease progression is common cold and hypothermia. Presently, specialists know more than 350 viruses that can cause the inflammation. 70% of infectious diseases rate is related to respiratory viral infections. In epidemic period, this figure amounts to 95%. Besides direct influence on the organism a lot of respiratory viruses can also impact one`s health in an indirect way – by causing complications and somatic diseases.
Pilot studies are usually done as a pre-step further to a larger study. Having results of the pilot study it is then easier to review the study design, calculate the needed resources for a broader further trial. Pilot studies usually enable to:

  • Calculate the sample size
  • Confirm the randomization procedure
  • Define the consent rate
  • Decide whether intervention is acceptable
  • Test the forms aimed at collecting data (for instance, questionnaires, etc.)
  • Select primary outcome measures
  • Integrate the needed additions/amendments to the future trial protocol

OCT can assist you in developing the whole programme of clinical trials for your product and conducting the studies either in one of OCT countries of operation, or in several. Pilot studies may be crucial for planning further development activities related to your investigational product.