Drug trials are carried out according to the international GCP (Good Clinical Practice) standard so that all drugs are tested according to the strict unified rules.
Before a drug enters clinical trials involving human participants, it is studied using one or two methods: in vitro (in a test tube) and in vivo (on laboratory animals). If laboratory tests have shown that the drug is effective and does not threaten life, it proceeds further - to clinical trials, which in turn consist of five phases.
The method, duration, participant requirements, and other clinical trial details are specified in the Study Protocol.
The patient must be familiarized with the study protocol prior to the testing. If the participant is satisfied with all the conditions, he signs an informed consent, in which he confirms that he has read all the documents and voluntarily decided to take part in the testing.
The study protocol is the main document of the study. All the smallest details are stated there: how, at what time, drug dose, and infusion rates; how often and what amount of blood should be taken for testing, what tests to perform, how often to do MRI and CT, and how many times a day and in what form to send the reports to the company organizing the research. The study protocol describes statistical and organizational aspects as well.
It's hard to believe, but even if the research is carried out in hundreds of clinics worldwide. In countries where people speak different languages and sometimes use different treatment standards and diagnostics, all processes, procedures, and data registration in the study are as standardized as possible. All this does not mean that there are no violations - but constant checks allow you to minimize the risk, and when analyzing the data, the risk of errors is also taken into account.
As a result of many months of accurate fulfillment of a long list of requirements, constant monitoring of the patient's state, consolidation of data by tens of different parameters, we conduct research, which will be published. Doctors around the world will use the result; the expanded ability to use new drugs. And several dozens of people have a chance for treatment right now.
Research also means a lot of checks: the quality of the collected data, the presence or absence of violations, and ethics are constantly monitored. If there are any important new data, they are reported to all researchers in the world, at the same time notifying the ethics committees. If changes are made to the study, patients will definitely learn about them and must again give the written consent for further participation (or disengage themselves from it). Any participant can leave the study at any time without giving reasons.