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SOTIO is working to confirm its promising research results in multiple clinical trials in order to assess the safety and efficacy of the SOTIO® DCVAC platform.
SOTIO is also collaborating with its affiliated and partnering companies (Cytune Pharma, NBE Therapeutics, Lead Discovery Center) on bringing their programs to the clinical development stage. For more information see the PPF/SOTIO Biotech Pipeline section.
What is a Clinical Trial?
Clinical trials test new ways to prevent, diagnose or treat diseases. They test investigational medical products and devices or explore new ways of using existing treatments, such as investigational drugs, vaccines, surgical procedures and radiation techniques or combinations of different treatments. Based on the results of clinical trials, scientists can evaluate investigational treatments in relation to safety and efficacy (whether they work better than existing methods). Clinical trials are also often referred to as clinical studies, medical research trials or simply trials. Most of the pharmaceuticals that we use today can be traced back to the results of clinical trials conducted in the past.
Phases of a Clinical Trial
There are four phases in the Clinical Trial process – referred to as Phases I-IV. Each phase of a clinical trial has a different purpose and helps scientists to find answers to various questions.
Phase I involves a small number of participants and is primarily aimed at evaluating the safety of the treatment, testing its pharmacological properties, and determining an appropriate dosage.
During Phase II, attention is focused on demonstrating the efficacy of the investigational treatment and specifying the appropriate dosage. This phase involves more patients (100 to 300 individuals) from several clinical trial sites.
The investigational treatment is administered to hundreds or thousands of patients. During this phase, the safety and efficacy is compared to standard treatments or a comparator drug or a placebo. Typically, this phase takes place at many clinical trial sites in various countries. The results are crucial for the decision regarding the new investigational treatment and whether it would move forward to be widely available. This would mean a decision on registering it for routine clinical use.
The registered treatment, often referred to as ‘post marketing’, will continue to be evaluated in order to obtain as much information as possible during long-term use in routine medical practice.
Participation in a Clinical Trial
Only a physician conducting a clinical evaluation of an investigational treatment can include a patient in a clinical trial. If a patient would like to participate in a trial he/she can contact one of the physicians at participating medical centers.
Patient Safety in Clinical Trials
National and international regulations and supervisory authorities have been established to protect the rights, safety, and physical and mental well-being of those who take part in clinical trials. Their task is to ensure that clinical trials are conducted in line with the highest scientific and ethical principles and their main objective is the protection of subjects who consent to participate in clinical trials.