About clinical studies

A clinical trial is "any investigation involving human subjects", that tests new medical treatmentsdrugs or therapies to determine their safety and efficacy.

Clinical trials are crucial for the development and validation of new medical approaches, to enable advances in healthcare and improve existing treatments.

As a clinical trial participant, you will receive continuous, intensive medical care from an expert team of experienced physicians physicians and medical staff, who are always for She is reachable. This enables more detailed Examinations than your standard medical care. They also gain access to new Therapy optionslong before they were available on the market. available are. By your willingness to participate, you will make an important contribution to the development of the Therapy options of tomorrow and enable thus also provide other people with an improved prospect of treatment options.

Clinical trials are generally divided into several types: Observational studies, in which researchers observe and measure health outcomes without intervening, e.g. studies for digital health applications (DiGA); intervention studies, in which researchers test a drug, surgical procedure, or other treatment; and diagnostic studies, which focus on better ways to detect specific disorders or diseases. Each type aims to answer specific questions about health and treatment.

In randomized trials, participants are randomly assigned to a treatment group (e.g. drug A and B). assigned, to ensure that the investigator's influence is not reflected in the study results. In some cases however on Randomization waived be. Dann is a non-randomized study and the allocation is assigned on the basis of a specific principle.

In a double-blind study, neither the participants nor the the investigatorwhich group (treatment group or control group) a participant belongs to, in order to avoid any bias in the study results. bias in the results of the study. the results of the study.

Eligibility criteria may vary by study. Typically, participants are selected based on certain factors such as age, gender, medical history, and the presence of specific diseases. Each study has its own inclusion and exclusion criteria.

If you are interested in participating, you should first research what studies are pending for your specific condition or area of interest. You should then contact the researchers or clinical trial center for more information and to see if you meet eligibility requirements.

Inclusion criteria are certain characteristics that a participant must meet to be eligible for a study. They help ensure that the study provides relevant results.

Yes, exclusion criteria may include factors that could affect the safety or accuracy of study results.s. These are also certain characteristics that a participant should not meet, such as other preexisting conditions, etc.

Clinical trials take place in so-called trial centers. These may be, for example, physicians' offices or clinics and are facilities that have the necessary equipment and personnel trained for the study and are specialized in conducting studies. An investigator trained to conduct clinical trials is responsible for ensuring that the study is conducted according to protocol and that the patient is fully informed.

Information on current studies and trial sites can be found at medical centers, research institutions or online databases. On the portal Future for Patients you will find current available studies.

Clinical trials are conducted not only in hospitals, but also by physicians in private practice. Pharmaceutical companies are often the clients of such studies, but universities or hospitals can also initiate such studies. An educational interview will be conducted prior to potential participation. Here you will be informed about goals, methods, advantages and possible risks. After sufficient time to think about it, you can decide whether you want to participate in the clinical trial. Participation is always voluntary and can be terminated at any time without giving reasons. The initial consultation will be followed by the screening visit, during which your eligibility for the study will be assessed. If the assessment is positive, the baseline visit occurs, in which baseline values are recorded and then the study medication or a placebo is administered. During the treatment phase, regular visits are scheduled to monitor your health, the effectiveness of the medication, and any side effects. After the treatment phase, there is a follow-up phase to evaluate the long-term effects and safety of the medication.

Before you choose for Decide to participate in a study, will guide you through the process. the investigator will conduct an intensive educational discussion about the course of the study. You will explainswhich advantages you have through the study and which possible Risks exist. You will receive a detailed and written description of your clinical picture and informationen üabout the commonalready anerkennt treatment optionstions. You willthe also about it that you can stop participating in the study at any time.the study wider callsn canwithout any disadvantages arising for you. After sufficient time to think about it, you sign and the Prüfarzt a Erklärung and profess, that the Recconversation stattgefunthe has. FFor Your persersonal Receive documents at home You the outuch Patient information and your Agreementsrklärung.

As a participant, you have the right to be fully informed about the study, including potential risks and benefits. You may terminate your participation at any time without affecting your medical care. All personal information is treated confidentially.

Yes, participation is always voluntary and you can stop it at any time without negative consequences.

Participation in clinical trials is voluntary, and your decision not to participate will not affect your medical care or your relationship with the doctors and researchers.

If you are ready declareto become part of a clinical trial support It thus supports medical research in the search for innovative and more effective therapies and drugs. With this you can you can help other patients in the near future treatment options and thus make a direct contribution to the medical progress of society. By taking part in a clinical trial, you yourself have the Possibilitynew and more effective active ingredients before they are available on the market. available are. In addition you will during intensively cared for by medical staff throughout the study and receive a variety of additional examinations, such as precise blood tests, ECGs, blood pressure measurements, etc. Thus can you yourself also benefit health-wise from participating. You will also receive information about the current state of medical research in the field of your complaints and diseases.

No, all for treatments and medications necessary for the study are for You for free. In many studies, you will also receive travel reimbursement and a Expense allowance. For more details will be provided by the responsible investigator at educational interview explain.

The participation of healthy volunteers in phase I studies is in principle remunerated. However, even in the other phases of the study, patients usually receive a Remuneration. This is dependent on various factors dependent. For this include among other things the possible risk and the time involved. In addition to the reimbursement of travel expenses, it is commonthat patients receive lump-sum reimbursements for receive individual visits or the entire study. Depending on the type of study, special expenses (special examinations, more time required) will also be remunerated. Please inform yourself with the respective contact person for the study according to the exact amount of the remuneration.

Yes, your personal information will be kept strictly confidential and used only for the study purposes. This is in accordance with data protection laws and regulations, including the European Union's General Data Protection Regulation (GDPR).

An ethics committee reviews and approves clinical trials to protect the rights, safety and welfare of participants.

Yes, the safety of the participants is a top priority. Clinical trials are carefully planned and monitored to minimize potential risks. Prior to participation, researchers must disclose all risks and potential benefits of a study, and participation is always on a voluntary basis.

Before a drug is tested on humans, it has a long-term development time behind it. At the very beginning, there is the active ingredient discovery. This involves a targeted search for an active ingredient that has a specific effect in human Body evokes. Once such an active ingredient has been identified, it must undergo many laboratory tests. If, after these trials, it is concluded that the drug is safe, it is finally tested on animals. Here checkswhether the distribution of active ingredients corresponds to the previous calculations. and whether the preparation has a toxic effect in the living organism. In addition must tested whether the new active ingredient achieves better results than drugs already approved on the market. preparations. Are these requirements fulfilleda Phase I study in humans can be applied for. For this all points are checked again by responsible authorities and ethics committees reviewed. Only then are drugs tested on humans in very small doses.

As a participant in a clinical trial, you are during the entire study period, i.e. from the first screening to the final examination, completely insured. Depending on the study, insurance is provided either by the client (also called the sponsor) or by the responsible Contract Research Organization. The insurance cover includes any damage incurred by the participant as a result of the study, and also covers the outward and return journey of the subject/patient.

SCREENSHOTS IN? Phase 1 In phase I trials, new drugs or new treatments are tested for the first time in a small group of healthy volunteers. This involves checking how the drug acts on the human organism (pharmacodynamics) and how it is absorbed, distributed, metabolized, degraded and excreted in the human body (pharmacokinetics). This determines the effective dosage at which the lowest possible side effects occur. The information collected on the safety and tolerability of a new drug is the basis for conducting a phase II trial. This can only be done if the side effects are not too severe. Phase II In phase II trials, new drugs are administered for the first time to patients suffering from the target disease. The goal of this phase is to determine a dose that will show the desired therapeutic effect while minimizing side effects. Phase III studies will not be approved until Phase II studies can demonstrate that side effects are acceptable. Phase III Phase III trials are conducted in a larger group of patients and are designed to confirm the safety, efficacy and safety of a drug. This phase runs under real-world conditions and is also designed to identify rare side effects, drug-drug interactions and optimal dosing. In this phase, the new drug is often compared in a comparative study against previous standard therapies or placebo. Thanks to intensive medical care, the risk for participating patients remains low. Phase IV
Phase IV trials are conducted after a new drug is approved. They are used to gather additional information on the efficacy and safety as well as long-term risks of a drug and are therefore performed in large patient groups. This means that even very rare side effects can be recorded.

After completion of the study, the results are usually published in scientific journals or on study websites. published. You can hhere at regular intervals your ask your study doctorwho has access to this data.

The data obtained will be analyzed to provide new insights and possibly further researchen or treatment approaches.

Individuals who voluntarily participate in a clinical trial to learn about the effects of the treatment or substance being studied on the human body.

Regulatory agencies that review the approval of new drugs and treatments for safety and efficacy.

An independent body that approves the conduct of the clinical trial and reviews the ethical aspects and safety of the participants.

The act of unblinding during a study to identify the treatment each participant received. This is usually done only in an emergency or after the study is completed.

In a clinical trial, participants are often divided into two or more groups. The test group receives the treatment under investigation (e.g., a new drug), while the placebo group receives an inactive placebo or standard treatment to compare the effectiveness of the new treatment.

A detailed plan describing the clinical trial process, including study design, conditions of participation, treatment plans, and data that will be collected.

The sites where the clinical trial will be conducted. These are usually medical facilities, hospitals or clinical research centers.

The medical specialists who manage and supervise the clinical trial. You are responsible for the proper conduct of the study, including adherence to the study protocol and participant safety.

A qualified nurse or healthcare professional working in a clinical trial who is responsible for the care of study participants. The Study Nurse is often the first point of contact for participants and provides support throughout the study period.