Clinical Trials
What is a clinical trial?
Clinical trials are research studies, in which a reference medicinal product (original), that exists on the market and generic medicine, which contains the same active ingredient, in the same quantity, is administered to healthy subjects, in order to compare concentrations in biological matrices (blood, urine, saliva, etc.)
All procedures are performed related to a clinical trial according to the protocol approved by the National Agency for Medicines, Medical Devices, and the National Commission for Bioethics Medicines and Medical Devices.
What are the 4 phases of clinical trials?
The Drug Development Process
Step 1: Discovery and Development.
Step 2: Preclinical Research.
Step 3: Clinical Research.
Step 4: FDA Drug Review.
Step 5: FDA Post-Market Drug Safety Monitoring.
How can you participate in a clinical trial?
In the trials without a therapeutic advantage, only the subjects who express their personal approval are enrolled (in an approval paper, expressed learnedly, approved by the Ethical Committee and NAMMD before it is presented to the subjects).
In order to participate in a clinical trial, the subject has to comply with:
The necessary conditions for good development of the drug administration stage
The diet prepared by the trial team
The sampling program of biological samples
The restrictions imposed via the approved clinical trial protocol (for instance: simultaneous medication, physical activity, diet)
The participant in a clinical trial has the following rights:
The confidentiality of the personal data
The detailed information, in non-technical terms, about the procedures of the clinical trial, the testing drug, the risks, and the advantages of the participation.
The necessary thinking time before the approval paper expressed learnedly is signed.
The withdrawal of the trial at any time, without being forced to communicate the reason of its decision and without being caused any prejudice as a consequence of his withdrawal.
Why participate in a clinical trial?
You benefit from a complete physical examination, medical analyses (inclusively for HIV and Hepatitis B, C), and paraclinical examinations (if it is the case) – for free
Accommodation facilities and free meals, TV access, internet, and medical assistance are assured
Medical assurance is completed for possible prejudices regarding the medication administration of the clinical trial
You are paid according to the period of participation and the complexity of the clinical trial
You benefit from a complete medical final exam
What are the risks of participation in a clinical trial?
The risks of participation in such a trial are minimal due to the fact that:
It is generally administered on health subjects only one dose/period
The testing drugs are well known and used in the current medical practice
The known side effects of the testing drugs are brought to the attention of the subjects before their enrollment in the clinical trial. The active substance, responsible for the therapeutic effect of a drug, is not an unknown/new component. This one is part of the composition either of the drug of preference, but also of the test and the therapeutic effects, as well as the side ones that are known to it from the medical practice of approximately 10 years.
Why do clinical trials fail?
Failures can arise from a lack of efficacy, issues with safety, or a lack of funding to complete a trial, as well as other factors such as failing to maintain good manufacturing protocols, failing to follow FDA guidance, or problems with patient recruitment, enrollment, and retention
Citation:
https://en.wikipedia.org/wiki/Phases_of_clinical_research
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092479/