Background of clinical research
Clinical drug research plays a crucial role in the development of new medicines and treatments. There are still many diseases for which effective treatments are lacking, and the discovery of new medicines is essential to address them. By participating in clinical drug research, you contribute to the development of these new medicines, which will ultimately benefit those in need.
A new medicine goes through several phases of testing before it can be prescribed to patients. After extensive laboratory research, testing on humans begins, known as “Phase I” research. In this phase the medicine is given to humans for the first time. Only if the drug demonstrates to be safe in the laboratory, proceeds to this phase. At DELPHINIUM we conduct Phase I studies, generally involving healthy volunteers.
During Phase I studies, we investigate whether the medicine is safe and how well people tolerate it. Any side effects are carefully documented, and the health of the volunteers is closely monitored throughout the study. Regular blood samples are taken to measure the concentration of the medicine in the body. Additionally, the new medicine is compared to a placebo (a fake medicine) to determine if any observed changes are truly caused by the drug or something else.
Your stay at DELPHINIUM may range from one night to multiple nights, depending on the specific study you choose to participate in.
Safety during clinical trials
Your safety is the top priority of our research team. That is why the study will only begin once all the laboratory results are available. An independent Medical Research Ethics Committee (MREC) will review the study in advance to ensure safety and assess potential risks. Before you decide to participate, you will receive detailed information about possible side effects and have the opportunity to ask all your questions. In situations where a medicine has not been given to people before, we always begin with a very low dose.
During the study, you will be closely monitored by doctors and nurses. You may experience side effects from the medicine or certain procedures during the study. While these effects can sometimes be uncomfortable, they rarely pose a serious threat. If the doctor believes that it is unsafe to continue, your participation will be immediately stopped. Remember, participation is always entirely voluntary, and you have the freedom to withdraw from the study at any time.
Compensation
You will be compensated for participation in the study. The amount you receive depends on the study itself and is not based on the side effects or risks. The compensation is based on factors such as duration of the study, any required medical procedures, and the frequency of follow-up appointments. Additionally, you will be reimbursed for your travel to and from DELPHINIUM.
The Medical Ethics Review Committee (MERC) always assesses whether the compensation is fair in relation to the study.
The compensation is gross and is considered taxable income. You will receive payment upon completion of the study, which includes all of the follow-up examinations. If you are not approved to participate, you will receive compensation for the screening and travel costs.
