Clinical trials peculiarities
Clinical trial (clinical study) in patients is an obligatory stage before new drug registration.
Clinical trials are aimed at revealing either positive or negative response to the drug that might be momentary or delayed due to drug accumulation in the body. Trials’ duration varies from couple of weeks to several years.
Clinical trials may be either observational or experimental. Observational ones are then divided into:
- Descriptive (description of the case, series of cases, single-point study or inquiries).
- Analytical (case-control, cohort analysis, experiment observation)
Despite of the study type, a number of peculiarities may be revealed that affect human’s life and regulated by law.
How studies affect humans’ lives
No change of way of life is anticipated, and patient continues to stick to it the same way it was before the trial, e.g., work, rest, dispensary, domestic treatment, etc. Experimental drugs should not enhance the effect of the drugs prescribed to the subject to treat definite disease.
Each study phase should be controlled, e.g., preparation of the subject to the study, treatment initiation, periodic control, and end of treatment and follow-up (for some period after end of treatment)
Current requirements for clinical trials conduct
Russian Laws and Ministry of Health orders strictly regulate patient’s participation in clinical trials. These should be conducted in duly accredited study sites and may be sponsored by contract-research organizations or pharmaceutical companies. The latters may, if satisfied with the study results, register the drug on market and thus compensate for the R&D costs. Clinical study results may contribute to market promotion of the drug and to scientific problems settling.
Essence of the clinical trials is observation of ethical norms and rights of the subjects. Before the study initiation, the owner must obtain the IEC (Independent Ethic Committee) approval; the main task of the Committee is to protect rights and health and to ensure safety of the participants. Independent Ethic Committee considers the information of the drug, clinical trials’ protocols, informed consent forms and CVs of principal investigators with the following risk/ratio assessment.