Photo: Cornel Putan
Phase 1 clinical trials, which are the first step in clinical testing of a new treatment or drug, are designed to assess the drug’s safety and tolerability and to determine the optimal dose. The research will be carried out at OncoHelp – a first for a hospital in Timișoara – on a small number of participants and will be closely supervised by doctors and medical regulatory authorities.
The main purpose of phase 1 clinical trials is to evaluate the drug’s safety profile and to identify any side effects or risks associated with its use.
„Phase 1 clinical trials may be an option for patients for whom no other standard treatments are available. Participation in these studies can bring a ray of hope for these patients. Phase 1 clinical trials can provide the opportunity to access experimental treatments that may provide them with therapeutic benefits. However, it is important to emphasize that participation comes with uncertainties. Because phase 1 clinical trials are primarily focused on evaluating the drug’s safety and tolerability, its effectiveness may not yet be fully known or proven.” explains dr. Cristina Oprean, primary medical oncology doctor.
In phase 1 clinical trials, the absorption, distribution, metabolism and elimination of the drug from the body are evaluated, as well as any side effects or adverse reactions. Interactions with other drugs as well as potential contraindications are also being investigated.
The patient’s decision to participate in such a study should be made carefully and after a detailed discussion with the attending physician. It is essential that the patient and his family have all the information about the objectives, procedures and risks involved in the study.
Dr. Cristina Oprean also says that participants in phase 1 clinical trials are informed in detail about the risks and benefits that may result from the administration of a treatment and are asked for voluntary consent before participating. “These studies are subject to strict ethical and medical regulatory rules to ensure the protection and safety of participants.” adds Dr. Cristina Oprean The information obtained from the administration of the drugs provides essential data for the continuation of the research in the next stages of the clinical trials.
Within the OncoHelp Association – OncoHelp Oncology Center, several studies are currently underway, but of the last phase, these being completely different from those whose application will begin in the next few weeks in Timișoara. Most clinical trials address patients with lung cancer, breast cancer, digestive or urogenital and gynecological oncological conditions.
All studies, OncoHelp officials say, are approved by the National Medicines Bioethics Commission and the National Medicines Agency of the Ministry of Health.
2024-02-28 07:32:15
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