This question is usually asked by the clinical research team to patients at Instituto Mário Penna who can join clinical trials. But before hearing the answer, some explanations are essential.
A research volunteer, also known as a research participant, is a person who agrees to use a new drug that is in the testing phase and that may be beneficial for the treatment of cancer. The identification of potential volunteers is carried out by the team of oncologists who indicate those who can participate in the studies. For this invitation it is necessary to check three fundamental points:
1 – Does the test treatment provide more benefit than the standard treatment? In some situations, clinical studies offer medications that are not available in the SUS or in the health insurance, and that already show promising results compared to therapies used in routine, and that can increase lifespan or cause fewer side effects. In other situations, the patient has already gone through a long path of treatments and the therapy options have already been exhausted, leaving the oncologist to repeat a treatment that has already been done before. With clinical research it is possible to enable a new line of treatment.
2 – What happens when I participate in the clinical trial? The clinical study does not start before the patient is informed about the risks, benefits, follow-up tests, medications used, side effects, treatment time, consultations and all other information necessary to guarantee their right to make a decision. After clarification, a document called the Informed Consent Term (FICF) is signed by the patient and the physician responsible for the guidelines given. The term contains all the information discussed and the contacts of those responsible for the clinical protocol.
3 – Does the patient meet the study’s safety criteria? Before the clinical study arrives at Instituto Mário Penna, other analyzes are carried out regarding the drug, making it possible to know the main side effects it can cause, thus excluding patients who may have any risk factors for taking the medication. Several tests are performed between signing the consent form and before administering the first dose of medication, with the aim of getting to know the patient.
Cíntia Lima, Clinical Research Coordinator Nurse, emphasizes that a patient who is well informed about the possibilities of treatment in oncology will certainly have no difficulty in answering the question in the title of this text. She also reinforces that the mission of the clinical research team is to offer the best treatment to patients and ensure that their wishes are respected.
*Text written by Cíntia Lima, Enf. Clinical Research Coordinator