You have probably heard about clinical research in the past, or read about it in the media. Have you ever wondered what clinical research, or a clinical study, is about? It can sound complicated, especially when medical terms are discussed.
But in reality, clinical research is not at all complicated and can be incredibly helpful and even life-changing. Here are some of the basics you should know:
Clinical research is a branch of medical science in which human patients are studied through health and illness in order to gain medical knowledge. This knowledge is later used to establish therapeutic options for different pathologies.
History of Clinical Research
Clinical trials are not new. In fact, there are historical records that show that primitive clinical studies were already being conducted years B.C. The Old Testament describes how, under King Nebuchadnezzar II’s orders, the royal princes followed a specific diet; after some time, he noticed that these individuals were healthier than the ones who followed a different diet.
The first controlled clinical trial was carried out in 1747 by James Lind. Trying to combat scurvy, he included a supplement in the diet of several sailors who suffered from the disease while they were at sea. He divided the sailors into six groups, and he gave each group a different element: sulfuric acid, vinegar sea water, citrus fruits, and spice and barley water. After some weeks, only the group which received the citrus fruits was healthy and fit for duty; thus confirming the hypothesis that these fruits (due to their Vitamin C content, then unknown by Lind) could be used to treat scurvy.
After this, clinical trials grew more popular and began to evolve. Sir Ronald A. Fisher, for example, published articles on the importance of randomization, replication, blocking, and the use of factorial experiments. The first randomized, curative trial was carried out by Sir Geoffrey Marshall between 1946 and 1947 to test streptomycin and its efficacy in treating pulmonary tuberculosis.
Clinical research can be divided into two broad categories: clinical trials and observational studies.
Volunteers or participants receive specific treatments, following a study protocol or plan which is developed by the investigating team. These treatments can include new drugs or interventions which haven’t been tested in humans before in order to compare their effects to those of well-known treatments, or they can take a treatment or procedure that is already in use and apply it to a different illness for which it hasn’t been approved, to find out if it can be used to treat different diseases.
Some clinical trials are as simple as applying changes to the patients’ usual routine, behavior or even diet. Many clinical trials include a placebo group in which the participants receive no intervention or drug. This is done to ensure the intervention is truly effective and that it isn’t affected by the volunteers’ emotions.
Since clinical trials are, by definition, experiments, their outcome is not known beforehand. This means that the extent of the benefit a patient will experience after the trial is unknown to the investigators. The safety and efficacy of these trials is determined by the investigators through the measuring of certain parameters, which are established before the clinical trial begins. It is also important to note that certain procedures are in place during trials to ensure a patient’s wellbeing if they feel unwell during the trial.
Clinical trials can be further divided depending on their goal into research, prevention, diagnostic, screening, genetic, epidemiological, and treatment trials, amongst others. They also go through different phases (I to IV); each of these phases has a different goal and involved a different amount of volunteers, which grows as the study moves onto the next phase.
In these type of studies, the investigating team determines the outcome of patients who receive drugs or undergo procedures as part of the routine care plan, without trying new interventions during the study. These studies are aimed at better understanding the effects and benefits of treatments that are already used for certain diseases and conditions.
Who Carries Out Clinical Research?
There is a research team in charge of every clinical study. This team is led by a principal or chief investigator, and the team can include medical doctors, nurses, and other healthcare personnel. Before the clinical trial is approved, they are tested in laboratories by researchers, who are in charge of determining their safety before human trials can be carried out.
Studies can be funded or sponsored by different companies, associations, or individuals. These usually include pharmaceutical companies, hospitals, volunteers, or even government agencies. The trial itself can be conducted in a variety of places, depending of the trial’s specifications and needs; these places include hospitals, universities, research laboratories, clinics, doctors’ offices, amongst other places.
Their length is also variable, and it depends on the subject that is being studied. They can last days, months or even years. Volunteers are informed on the trial’s projected length before it starts.
How are Patients Protected During a Clinical Trial?
If you are curious about participating in clinical research but you’re worried about its possible consequences on your health or privacy, you’ll be relieved to know that there are certain measures that are put in place during any clinical trial.
Informed consent is of utmost importance to researchers undertaking a trial. Vital facts about the research are shared with the patient so that they can make a decision whether to participate in the trial; any patient participating in one will be given the option to give consent –or refuse it- at the beginning of the trial. Even if a person signs the informed consent, this doesn’t mean that they can’t withdraw from the study; on the contrary, any participant is able to leave the trial before it ends.
There are also Institutional Review Boards which monitor each clinical trial, and they must review and approve the procedures being carried out during the research. Several federal agencies can also determine whether volunteers are being adequately treated and protected during the trial.
Clinical research is a way for patients to get involved in their own healthcare, seeking different treatment options for their conditions, possibly improving their quality of life, and helping advance medical science along the way; always under the care and guidance of some of the top medical professionals in their field.