Disclaimer: Not medical or professional advice.
Fact: Illegal clinical trials make no sense, as pharmaceutical companies' goal is entirely different – developing and selling the new drug. And the clinical trial is an obligatory stage before the drug gets registered and before it can be used by society.
A drug that has not been clinically tried can not be introduced to the market. Without this, pharmaceutical companies will not be able to reach their commercial goals.
On the website clinicaltrials.gov you can get any information on the issued permissions for clinical trials: the protocol name of the study, a drug that is being tried, sponsor company, duration of the study, clinical centres where the research is permitted, number of participating patients and the current state of the study (ongoing, completed, suspended or discontinued). The database is being updated with new information about studies coming in.
Fact: In the US, Europe or Japan, the insurance-based healthcare system, including drug insurance, is significantly developed, and patients have access to the newest drugs and medical technologies. In the developing countries, participation in the clinical trials is the only possibility for patients with severe diseases to get properly qualified medical help and costly treatment for free.
If the testing area was limited to the developing countries, whose population is not more than 15% of the planet's total population, it would be impossible to recruit the required number of patients. This means that drugs will either not be introduced at all or registered with a significant delay. International multicentral studies around the world are done according to international standards. Clinical trials are based on the ICH GCP (Good Clinical Practice). Its implementation is a prerequisite for drug registration in the US, the European Union, and other developed countries.
Fact: Any clinical trials involving people are permitted only with the participants' voluntary consent and with no harm done to them. These ethical principles are governed by the norms of international law.
Ethical principles of the clinical trial's performance are also stated in the documents such as the Council of Europe Convention on health and biomedicine (Oviedo Convention) and an additional biomedical studies protocol.
Before being accepted to the clinical trial, the patient receives all the information on the study's goals, methods, and organization and the possible benefits and potential risks related to the participation in the study. The patient signs an informed consent form, confirming that he or she has given a voluntary consent, that he or she is informed of the research and understood the information. In turn, the research doctor signs a form confirming that he or she has given all the required information about the study to the patient. The patient can, at any time, withdraw from the study without an explanation of the reason.
The no-harm principle strives to maximize the benefits and reduce the patient's risk in the clinical trial. Research can only be done if the expected dangers for the patient do not exceed the potential benefit. In practice, the research protocols are thoroughly rated by the patient's benefit/risk point of view. Clinical studies around the world are controlled by the government and society. The clinical study process is governed by the representatives of the performing company, monitors and auditors. A patient participating in a clinical trial is under the supervision of highly qualified specialists and has access to the most modern drugs and technologies.
Fact: Modern clinical trials often use a comparative study design: one patient group receives a studied drug. In contrast, another group uses a comparable drug (this group is called a control group). In this way, scientists can get a more reliable result. A new drug is compared to the standard treatment method to confirm the effectivity.
By the data from the Declaration of Helsinki of the World Medical Association, a "placebo" can only be used in two situations in clinical trials.
It is stated in the declaration that special measured should be taken to avoid unjustified use of placebo. When planning the trial or developing its design, the pharmaceutical company considers scientific and ethic aspects. Medical specialists and statisticians participate in this part. The issue of approval of a particular study using placebo as a comparable drug is solved by ethical expertise of the study.
Fact: Only the participation of healthy individuals in the first stage of the clinical trials is paid when it is evident that the study will not harm them. Participation in the next stages – second and third – are usually unpaid. This helps to reduce the patient's pressure and give him a chance to weigh the possible benefits and risks associated with the participation in the clinical trials. Sometimes, at the second and third stage of the clinical trials companies offer their participants financial compensation for travel expenses.
Fact: The pharmaceutical company's commercial interest is to register and successfully release the drug to markets around the world, repay the development costs, and make a profit. But it is impossible to register a medication without the approval of the authorized health authorities. Any non-compliance to the standards causes complete cancellation of all results. A company, indeed, incurs heavy loses.
If the new drug causes previously unknown side effects, then, FDA recalls the licence from the market. The drug recall outcomes are quite severe – there are financial and reputational losses for the pharmaceutical company. Suppose the drug is registered but is ineffective in medical practice. In that case, it is also unprofitable for the company – it will cover a tiny part of the market.