About Clinical Trials
A critical part in the process of bringing new therapies to patients is clinical development, the study of potential new therapies in humans. It typically takes more than ten years from discovery in the lab for a potential new therapy to gain approval for routine use in patients. Clinical development is the most time consuming and expensive part of the research and development.
Clinical trials involve volunteer trial participants. Every trial is governed using well-defined ethical rules and standards to protect participant safety. For patients suffering from a condition that is currently untreatable, participation in a clinical trial may provide access to potential new therapies. While participating, volunteers obtain closely controlled care in research medical facilities, in addition to helping others by contributing to medical research.
Trials conducted during clinical development generate thousands of pieces of data and are generally used by regulatory agencies to determine approval for use of the therapy.
Oncorena is in the last pre-clinical stage. The clinical development stage is expected to start in 2020. The current plan is to conduct the clinical trials on clinics in Sweden enrolling patients with metastatic renal cancer in dialysis from a wide geographical area.
Please note that only a physician can determine if a patient would benefit from enrolling in a clinical trial or not. If a patient has questions about his or her medical condition or possibility to participate in a clinical trial, the patient must consult a suitable qualified healthcare professional in his or her country for medical advice and specific information.
Phases of Development
An experimental therapy is first tested in the laboratory and in animal studies. After this pre-clinical testing, and only if shown to meet certain safety criteria and have value as a potential new therapy, the candidate advances to clinical testing in humans.
Early clinical testing
In trials for new cancer therapies the initial patients included are usually advanced cancer patients. The aim for these studies is to understand safety and tolerability for the new drug. Doses and how the drug is metabolized by the patient is also studied. In addition, signs of effect of the new drug are often analyzed, for example tumor shrinkage.
Pivotal clinical trials test the results of earlier trials in a larger groups of patients and gather additional information on the effectiveness and safety of the experimental therapy. These trials are often randomized, where participants are arbitrarily allocated to receive the experimental therapy, placebo or another therapy (a “comparator”), and “double-blinded,” in which neither the investigator nor the participant are aware if the therapy given is the true experimental therapy, placebo (medication with no active ingredients) or another therapy (a “comparator”). These trials are the basis for the application to register a new therapy.
Filing an application for registration with the country’s health regulatory authority is the next step in bringing a potential new therapy to patients.
Oncorena’s pre-clinical orellanine-studies will be completed in early 2019. The clinical study is expected to start in 2020. The current plan is to conduct the clinical trial in clinics in Sweden enrolling patients with metastatic renal cancer who are on dialysis from a wider geographical area. If you have patients with advanced renal cancer who are on chronic dialysis who may be eligible for inclusion in the clinical trial, please contact firstname.lastname@example.org.