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Clinical Trials – Improving Medical Treatment

When new treatments are developed clinical trials help to establish how well these particular treatments work, helping scientists and doctors to find better ways to treat their patients.

During your participation, your condition will be professionally treated completely free of charge, and you’ll be helping to improve treatment for other patients with the same condition. Clinical trials are essential for medical research and development of new treatments and medication.

“Clinical trials help doctors understand how to treat a particular disease or condition. It may benefit you, or others like you, in the future.
If you take part in a clinical trial, you may be one of the first people to benefit from a new treatment.”


Why do we need them?

Are Clinical Trials safe?

How do Clinical Trials work?


Here you can find the most frequently asked questions about clinical studies. Can’t find the answer to your question? Please do not hesitate to contact us via our contact form. We will be happy to provide further information.

Who can participate in a clinical study?
The study protocol will determined the criteria each participant has to meet. Examples for these inclusion criteria are age, gender, and the course of disease its severity. Everyone who meets the inclusion criteria may participate in the study.
Is the participation in a clinical study voluntary?
The participation in a clinical trial is absolutely voluntary, meaning you can cancel your participation at any time of the study without giving reasons for that. This will result in no disadvantages to you.
Why should I participate in a clinical trial?
As a participant in a clinical trial, you will receive continuous, intensive medical care from a qualified team of experienced doctors and medical staff, which is available for you at any time. This allows more detailed investigations than with your standard medical care. In addition, you will have access to new therapeutic options long before they are available on the market. By agreeing to participate, you will make an important contribution to the development of prospective therapeutic options and thus enable other people the prospect of improved treatment options.
How do Clinical Trials work?
Clinical trials are conducted not only in clinics, as the name implies, but also in doctors’ offices. The sponsors of clinical trials are often pharmaceutical companies. Clinical trials can also be initiated directly from universities or clinics. Before attending, you will be informed in detail and in writing by your doctor about the study and possible risks. If something is still unclear, your doctor will be able to answer your questions at any time. After a suitable period of reflection, you can decide whether you want to participate in the clinical trial. The participation is always voluntary and can be terminated at any time without giving any reasons.
How do I benefit from participating in a clinical trial?
By taking part in a clinical study you’ll be supporting clinical research scientists to explore innovative and more effective methods and medications for curing severe diseases. Helping other patients to receive the best possible treatment and giving you the chance of to become an active participant in medical and pharmaceutical progress. You will gain access to innovative and promising medications before they are available on the market. During the study, you will receive medical treatment from experienced medical personnel at your study-site, including a variety of additional inspections which are not included in the standard treatment you receive as a normal patient, for example additional blood examinations, electrocardiograms, blood pressure measurements etc. So your health stands to benefit from participating in a clinical study. Furthermore you will obtain information about the current state of medical research in the field of your complaints and diseases.
Who conducts clinical studies?
Clinical studies can be of commercial or non-commercial/ academic type. In commercial studies the sponsor is a company from the pharmaceutical medical technology industry that wants to research its own products. There is no direct contact between the sponsor and the patients/ subjects to avoid any influence on the study. Only the investigator and his/her team in the study sites have direct contact with the participants. Non-commercial or academic studies respectively are initiated by scientific institutions, e.g. teaching hospitals, to gain further research results in the treatment of specific diseases or medications. In both types of studies the sponsors and the investigators have to adhere to strict guidelines and the patients/ subjects have the same privileges. The sponsor has the possibility to self-manage the study or he can assign a clinical research organization (CRO) like proinnovera GmbH to manage and control the study.
Where are clinical studies conducted?
Clinical studies are conducted in study sites. These are for example doctor's surgeries or medical centres and are institutions, which have the necessary instrumentations available and have employees who are experienced in clinical research. An investigator who is trained in the execution of clinical studies is responsible for conducting the study according to the protocol and the informed consent of the patient/subject.
How am I informed about the study process?
Before you decide to take part in a clinical study, the investigator will give you all relevant information concerning the study in an introductory conversation. He/she will clarify your personal benefits as well as the possible risks of the study. You will receive a detailed description of the disease you are affected by as well as information about established and already approved treatments. You will be advised of the fact that you are allowed to withdraw your consent at any time of the study without any detrimental effect on you. You’ll be given adequate time to consider participation and then you and the investigator will sign an informed consent form to verify that you have been fully informed about all important details of the study, especially the possible risks and side effects. You will receive the detailed patient information and informed consent for your own records.
Which trials does a medication need to pass through before it is tested in humans for the first time?
Before a medication is tested in human subjects, it will have been through a long developmental period. At first the researchers need to find the active component. They search for a component that provokes a specific reaction in the human organism. After an active component is identified, the researchers have to conduct a lot of laboratory tests. Once all the tests have been completed and assuming that the drug is safe, it is tested in animals to investigate the actual circulation within a living organism and if it shows severe side effects. We also need to establish if the new medication is superior to the standard medication which is already available. If all these requirements are completed, the sponsor can request the appropriate public authorities and ethic commissions for a permit to conduct the phase-I first-in-human study.
Phase I

In phase I trials, new drugs or new treatments are tested for the first time in a small group of healthy volunteers. It is examined how the drug acts on the human organism (pharmacodynamics) and how it is absorbed, distributed, metabolized and excreted in the human body (pharmacokinetics). As a result of these tests, an effective dosage with the least side effects is determined. The information collected on the safety and tolerability of a new drug is the basis for the conduction of a phase II trial, which can only be carried out if the side effects are not too serious.

Phase II

In phase II trials, new drugs are administered for the first time to patients suffering from the target disease. The aim of this phase is to determine a dose which shows the desired therapeutic effect and has the least possible side effects. Phase III studies are not approved until phase II studies show that the side effects are acceptable.

Phase III

Phase III studies are conducted on a larger group of patients and are intended to confirm the safety, efficacy and harmlessness of a drug. This phase is conducted under practical conditions and is also intended to identify rare side effects, interactions with other medicines and the optimal dosage. In this phase, the new drug is often compared to standard therapy or placebo in a comparative study. Thanks to intensive medical care, the risk for the participating patients remains low.

Phase IV

Phase IV trials are conducted after the approval of a new drug. They are conducted to record additional information on efficacy and safety as well as long-term risks of a drug and are therefore carried out in large groups of patients. As a result, very rare side effects can be detected.

Who controls clinical studies?
The procedure of a clinical trial is precisely defined and is controlled by public authorities and ethic commissions to ensure the safety of the patient's / subject's throughout the study. In addition to that, so called monitors will regularly check if the study teams of the site are adhering to the protocol. Monitors are employees of the sponsor or a clinical research organization.
How risky is participation in a clinical study?
When testing innovative medications, researchers venture into uncharted scientific terrain in principle. Accordingly health risks cannot be excluded completely. Nonetheless the risks for the participants are kept to a minimum by the implementation of prerequired extensive laboratory tests. A good portion of phase II-III studies investigates the combination of active components which are already approved separately and were tested in human subjects before or they examine long-term effects of medication that is already available on the market. Patients/ subjects have to visit the study sites for control examinations and are therefore under constant medical control. Therefore it is guaranteed that any occurring side effects will be recognized at an early stage and that the investigator can react adequately. The safety of our patients/subjects has absolute priority. As a participant of a placebo-controlled study you have to consider that you might be randomly assigned to the control group, which means that you will be given a placebo without an active component. Furthermore the medication could be ineffective and therefore your state of health might not improve significantly.
Will there be additional costs throughout the clinical trial?
No, all treatments and drugs which are necessary for the study are without charge. In many studies the sponsor reimburses the travel expenses and gives you a small allowance for expenditure. You will obtain further information in the introductory conversation with the investigator.
Will I be paid for participating in a clinical trial?
In principle, the participation of healthy volunteers in phase I studies will be remunerated. But also in other study phases, patients usually receive remuneration. The level of the total compensation is dependent on various factors. These includes, among other things, the possible risk and the time expenditure. In addition to the reimbursement of travel expenses, it is customary for patients to receive remuneration for individual visits or the entire study. Depending on the type of study, special examinations and a high expenditure of time will be additionally remunerated. For more information about the exact amount of the remuneration, please contact us directly.