There are currently about 20,000 clinical trials (“Clinical Trial” is a study in which humans receive the treatment) available to cancer patients, and only 2% of them are in Israel. Every cancer clinical trial has dozens of threshold conditions (criteria) which the cancer patient must fully meet in order to be enrolled. A great deal of work is required, thorough and comprehensive, to uncover those studies that are suitable for the individual unique patient.
Despite the not-so-attractive name, “Clinical Trial” is an opportunity for the patient to receive a treatment that is one of the most advanced and sophisticated in the world, treatment at the forefront of science, at the spearhead of fighting cancer. Some of these treatments and drugs have been given the status of a “breakthrough therapy” by the US Food and Drug Administration, the FDA, based on data gathered on its efficacy and safety, but it will take another 6-7 years to approval which means that by participation in a clinical trials the cancer patient is exposed to the most advanced treatment or drug, 6-7 years before it becomes available, and it is important to note that drugs in clinical trials are given free of charge to patients.
When talking about metastatic cancer patients and / or those whose type of tumor is particularly aggressive, time is a critical resource for them and it is important that they do not miss under the radar treatments that they might benefit from beyond any standard treatment offered to them.
Clinical research or clinical trials are conducted to evaluate the efficacy and safety of treatment or medication in humans. The goal of the study is to promote medicine and medical care- and thus the treatment of cancer – through the presentation of new and highly advanced treatments when evaluating their success, i.e., how effective and safe it is for patients.
Therefore, the world’s most advanced treatments for cancer are found in clinical trials.
Under the definition of “New Treatment”, a new drug, a new indication of a known drug or a new way to perform surgery or radiation therapy is introduced. “New Treatment” may be a new technique (such as gene therapy) or a new medical device.
Clinical trial in patients is a stage before the drug might be approved for use. Prior to clinical trial, laboratory studies are carried out, which are insufficient to determine efficacy and safety in humans. However, in this way, a great deal of important medical information has been gathered about the new treatment. Therefore, the treatment should also be examined in humans, and certainly when there is a solid basis for the assumption that the treatment may be effective.
The transition from a laboratory experiment to a human being is done using calculations, formulas and models that were approved and proved to be correct, safe and efficient when such a leap is made.
The first clinical trial in humans is called “Phase I”, followed by Phase II, III and IV studies. Only if a clinical trial proves what has been previously defined, we move on to the next phase and this is done on a larger group of participants. Hence, most of the studies are based on information that has been added from previous studies on innovative treatment in humans.
During the course of the clinical trial, all the implications of treatment, positive or negative, treatment efficacy, side effects and in phase I clinical trials various doses are examined to determine the optimal dose.
Clinical trials are the real progress in treatments for cancer patients, and in general, they may contribute to prolong life, improve quality of life and in some cases save lives. The consideration to enter a clinical trial is in the hands of the patient, the choice and consent are his and only his, as long as he fully meets the criteria of the trial.
Before joining the clinical trial, the treating oncologist is obliged to give the patient a complete overview of the treatment, its advantages and disadvantages, including side effects. The patient will then sign an “informed consent form” for participation in the trial. Participation in a clinical trial is free of charge, the drug is given to the patient free of charge and there are cases where, even after the completion of the study, the patient will still be receiving the trial treatment.
TRIAL-IN Pharma scours the globe for clinical trials and identifies the appropriate ones for the cancer patient based on his current medical background and medical history. We provide the patient with appropriate information, in a concise and clear manner, with which he will continue to consult with the treating oncologist to make a joint therapeutic decision.