About clinical trials
All the treatments and medications used regularly today were made possible by past clinical trials and the patients who participated in them.
What is clinical research?
A clinical trial is research conducted on humans to determine or confirm the safety and effectiveness of one or more investigational drugs or devices. For a new, safer, and more effective drug to be available to patients, a long and extensive research process has to be done.
The research process starts in the laboratory, afterward, the experimental studies on animals are done, and finally, an experimental study drug is tested on humans. Clinical trials enable physicians to incorporate the newest medical knowledge into treatments that may be valuable to patients.
Only 1 out of 10 drug candidates successfully pass clinical trial testing and get approval to be used in everyday clinical practice.
How does a clinical trial work?
Study participation is completely voluntary. Patients are free to leave the trial, at any time, without penalty or any negative consequences. In a clinical trial, a patient is usually assigned to one of the 2 study groups. Patients in one study group may receive an investigational treatment or study drug while another group of patients may receive a placebo or a treatment already available.
A placebo is an inactive product used to assess the experimental treatment’s effectiveness.
The patient and physician may not know which one receives a placebo and which receives the active treatment.
Not knowing which patients are receiving the active treatment allows the physician to objectively observe the patient during the study. Regardless of whether active treatment or placebo is received, the level of medical attention and respect that each patient receives is the same.
Who can participate in a clinical trial?
There are guidelines that determine who can participate in a clinical trial. The patient must qualify for the study. Criteria permitting patients to participate in a clinical trial are called inclusion criteria.
Factors that disallow patients from participating are called exclusion criteria. Examples of such criteria are age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Clinical trials seek patients with specific illnesses or conditions to be studied.
It is important to note that inclusion and exclusion criteria are used to identify appropriate patients and promote participant safety.
What is informed consent?
Before participating, every patient has the right to know and understand what will happen during a clinical trial. This is called informed consent, a process that can help patients decide if participating in a trial is right for them.
When a patient gives written consent to participate in a clinical trial, they acknowledge that they understand and accept all aspects of the research study, including any risks or benefits involved. However, informed consent is not strictly about signing a document.
It is a process that involves ongoing conversations between the patient and the physician. Informed consent can be withdrawn at any time without consequences.
Why should patients participate?
Every patient has a different reason for participating in a study. For some, it can be the additional medical attention that is provided to each study participant. Others may want to participate in a study because of the possible benefits of taking a medication that might help treat symptoms.
One thing to remember is that study participation is completely voluntary. Each patient should discuss the risk-benefit ratio with their physician. MSB Clinical Research will always inform patients of all known risks and benefits of study participation.