Medications and vaccines don’t come out of nowhere. They are not done in a rush and they are not due to commercial gimmicks. They are the result of years of research, analysis and checks that are carried out to assess the effect of these compounds on people’s health and the benefit obtained from them.
So whether it’s for the coronavirus vaccine or for a drug for a common disease or for cancer, any drug is subject to a clinical trial. But what is a clinical trial?
What is a clinical trial?
First of all we must understand exactly what this type of evaluation is. A clinical trial is a research study done in people to find out how a new drug or vaccine works against a disease. This type of analysis tries to analyze safety for people and its effectiveness. It can also be performed on a new drug or to compare with an existing one if it produces a greater benefit in the same disease or if it allows treating another.
Thus, the clinical trial aims to find out the efficacy of a drug, the adverse effects they may produce and what dose is the one that obtains the desired result.
“The discovery of a new drug begins in the laboratory, by identifying a new specific target, that is, where to attack to fight a disease. From there, a chemical or biological compound is designed that can attack that target and extensive tests are carried out in the laboratory and with computer simulations ”, they explain from Farmaindustria.
This preclinical phase continues with the evaluation of the compound in animals before the next step: designing a protocol in which the hypothesis to be tested is exposed, how many people will participate, how they will be selected and how the results will be analyzed. Once done, it is exposed to official bodies, health authorities and ethical committees; that is, to the Spanish Medicines Agency and the Ethics Committees for Medicines Research, which will give the green light to carry it out if they consider it so.
Participant safety and ethics
Clinical trials are supported by a series of good clinical practice guidelines. And for this reason, “the 1966 Helsinki Declaration, promulgated by the World Medical Association, lays the foundations of the ethical principles that all of us who are involved in medical research with human beings must follow,” explains Teresa Alonso, secretary to CuídatePlus scientist of the Spanish Society of Medical Oncology (SEOM), and medical oncologist of the Ramón y Cajal University Hospital, Madrid.
It is important, says Alonso, that it be understood that research is done with exquisite care and always guaranteeing the safety of the people who participate in it. In fact, before you can proceed to recruit patients to participate in a clinical trial, the research must be approved by an ethics committee of the center or hospital where it is to be carried out. “These committees are represented by professionals who are experts in different subjects and who analyze whether the indication for which a treatment is to be applied is within the standards of treatment for that disease; if the treatment and the security data they have are acceptable to administer it, if the center has the adequate infrastructure so that this clinical trial can be carried out… ”, says Alonso.
All this is essential to ensure that the research can be carried out, since in some cases the treatment is administered in the hospital quickly, in pill form, but in others injectables and advanced therapies are applied. It may also be necessary to analyze how people metabolize the treatment with the help of blood tests or imaging tests may be required or the patient may spend several hours or even a few days in the hospital.
Before the study is launched, the ethics committee must, necessarily, give the go-ahead. And from there you can start “the initial visits, in which the researcher can begin to offer patients to participate in the clinical trial,” explains Alonso. In addition, participants must sign an informed consent and their data will always be treated with confidentiality.