21 Aug Myths and truths about clinical trials
Clinical trials are secret. Myth
All clinical trials being conducted in a country have been approved by regulatory authorities, and the documentation is available to the public. Once the trial is completed, its final results are published in scientific journals that can be read by anyone. In addition, patients who have participated in the study have the right to know the results obtained.
The treatments provided by the clinical trial are at no cost to the patient. Truth
During clinical trials, patients undergo a number of clinical tests and are administered an innovative or best-in-class treatment. However, in no case does this treatment incur any costs for the patient. The clinical trial sponsor assumes all these costs and the patient, and only in certain cases, has to assume the costs derived from travel to the site.
Clinical trials are for terminal patients only. Myth
We’ve heard many times that clinical trials only serve people who have not had success with the available treatments, but the fact is that many clinical trials need healthy people or patients in an earlier stage of a disease. Depending on the phase of the clinical trial, different patient profiles may be needed.
Clinical trial participants are guinea pigs. Myth
Medicines tested in clinical trials have been studied in the laboratory and tested in animals for years before they are given to patients. In these previous phases, effects that could be harmful to people are detected, and only medicines that successfully pass the animal research phases will be used in clinical trials. The safety and well-being of patients is the top priority for investigators. In addition, trial protocols are approved by the AEMPS (Spanish Agency for Medicinal Products and Medical Devices) and the Medicinal Product Research Ethics Committees, which guarantee patient safety.
Once the clinical trial starts, I can stop at any time. Truth
The patient has the right to withdraw from the clinical trial whenever he/she wishes. Signing the Informed Consent Form does not obligate the patient to remain in the clinical trial until its end, contrary to what some people believe. The decision to stay in the trial always lies with the patient.
If a better treatment for my disease exists, my doctor would have told me. Myth
Not all physicians are aware of the new clinical trials that are underway. What’s more, Spain alone currently has more than 800 cancer clinical trials ongoing, so it is very difficult for a physician to be aware of them all. That’s why MatchTrial was created, to bring science closer to people and to make information about all available cancer clinical trials more accessible to patients and doctors.
The study doctor does not know whether I am receiving the study drug or the comparator drug. Truth
Clinical trials work with randomization to mitigate any potential psychological effects. That is, patients are randomly assigned to treatments. In addition, it is common to work with so-called double-blind trials. Double-blind means that, during the research, neither the investigator nor the patient know whether the study drug or control is being administered. It is common practice in clinical research, but it is not mandatory in all clinical trials.