Discovering and developing new medicines is a long and complex process.
It starts with laboratory research which involves experiments in human cells and in animals, the so called pre-clinical phase. If the initial pre-clinical research is successful the research is continued in humans, the clinical phase. Clinical trials are conducted to determine whether a new treatment is both safe and efficacious. These studies are possible because volunteers (healthy volunteers and patients) agree to participate and try new medicines (or vaccines) under supervision of experienced clinicians.
Clinical trials are typically divided in three phases:
- Phase I trials assess the safety of a new medicine. This initial phase of testing usually includes a small number of volunteers. This phase focuses on potential side effects of the new medicine at different dose levels. The trials are also designed to determine how the drug should be used or delivered.
- Phase II trials test the safety and efficacy of a new medicine. In this phase the optimal dose of the medicine is determined by testing different dosages. This second phase involves up to several hundred patients. Often these studies are "blinded" which means that patients are split into groups to receive the experimental medicine or placebo in a way that neither the patients nor the researchers know who has received the experimental drug. This set-up allows a careful and objective investigation of the safety and effectiveness of the new medicine.
- Phase III trials are confirmatory trials whereby the safety and efficacy of the new medicine is investigated in larger populations of several hundred to several thousand patients. This large-scale testing yields a more thorough understanding of the effectiveness of the new medicine and its benefit risk ratio. Once Phase III is successfully completed a dossier is submitted to apply for registration and marketing authorization of the new medicine.
The entire process can last several years and requires large investments. HAL Allergy is involved in an ambitious clinical trial program to develop new medicines intended to treat respiratory and food allergies around the world.
All our clinical trials are registered in an official public database: https://clinicaltrials.gov/
At HAL Allergy we are committed to the safety of patients who take part in our trials, and we uphold the highest ethical standards in all of our clinical research activities. Our clinical trials are performed by experienced physicians in the field of allergy at highly qualified clinical research sites.