Participate in Our Research

The Purpose

of Our Trials

The diversity of innovation leads to new individual needs that cannot be answered with the usual scientific methods. In our testing center we perform Phase II to IV safety and efficacy trials for pharmaceuticals, medical devices and cosmetic products. Our research team is glad to assist you with every single step necessary for a successful evaluation.

Frequently Asked Questions

What is a clinical trial?

A clinical trial is a research study that involves human volunteers to investigate medicines and new treatment options. Clinical trials are
the most effective method in discovering new successful treatments or improving existing. They can vary in size from a single center in one country to multicenter trials in multiple countries.

Before you decide to participate or at any later time point of a study the research coordinator or the involved doctor will discuss your rights and role for this study with you and answer all your questions. The participation in a research study is always voluntary and you can always decide to withdraw from the trial without personal disadvantages.

In all clinical trials at the Sadick Research Group the treatments, office visits, and tests are at no cost to the participant and an adequate financial compensation will be given.

What happens during a clinical trial?

The clinical trial process depends on the type of trial being conducted. Before a general medical history is taken, potential participants often sign an Informed Consent Form (ICF) that explains the purpose of the study, conditions that may include/exclude a participant, the procedures involved, risks and/or benefits, alternatives, and the financial compensation. This form is designed to provide patients with all of the information necessary to make an informed decision regarding their participation in a specific trial.

Patients are encouraged to ask the doctor or the person administering the consent form any questions that may arise. After reading through the ICF and clarification of all questions, patients may elect to sign or not sign the document. The ICF is not a contract and participation is always voluntary. The participant can withdraw from the trial at any time.

The further procedure after the signing of the ICF can be different in every study. The staff will usually check the health of the participant and give specific instructions for participating in the trial. This can happen at the same day the participant was enrolled to the study or at another day. Depending on the trial, patients have to follow a protocol at home or/and get treatments at the office. At prior defined time points, the research staff will examine the participant’s health again to monitor possible changes.

Before the study is completed, a final exam in the office will take place, where the health of the participant is checked again. After this, the participant has finished the study.

Why participate in a clinical trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. There are many reasons people take part in research studies.

In many cases, it gives participants access to a medicine/treatment that is not currently available. If this is the case, it is always important to keep in mind that the study is being performed to determine the safety and efficacy of the treatment, which means that there is some information that is unknown about this treatment and it is considered experimental. Your participation in a study may benefit you directly by providing you with a more effective treatment, and the information collected as a result of your participation may be eventually be used to help to other people with the same condition. Many research participants get satisfaction from knowing that they are part of an effort that may reduce the suffering of others.

Is it safe to participate in a clinical trial?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. Every trial follows a carefully controlled protocol; a study plan which details what researchers will do in the study. This protocol has to be approved by an independent committee made up of doctors, members of the general public, and others responsible for ensuring that a trial does not represent an unreasonable risk to patients.

The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Participants must sign an “informed consent” document before joining the study indicating they understand that the trial is research, and that they can leave the clinical trial at any time. This informed consent is part of a process that ensures a prospective participant in a clinical trial understands what known risks might be
associated with the study, and whether there are potential, but as yet unknown risks that may be associated with the product being studied. This information permits someone deciding whether or not to enter a clinical trial to make an informed decision about the level of risk they are willing to accept before they enter the trial. Although efforts are made to control the risks to clinical trial participants, some risks may be unavoidable because of the uncertainty inherent in medical research studies involving new medical treatments.

What should people consider before participating in a trial?

People should learn as much as possible about the clinical trials that interest them. They should also feel comfortable discussing their questions and concerns with members of the health care team. Prospective participants should understand what happens during the trial and the type of treatment they will receive. Anyone considering a clinical trial should also know that there are benefits and risks associated with participating. Potential benefits are e.g. to get actively involved in the own health care, to gain access to potentially new research treatments or to have access to expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied. Possible risks are unpleasant, serious, or even life-threatening side effects resulting from the treatment, a maybe ineffective treatment may not be effective or higher amount of time and attention than a standard treatment.

Is there financial compensation and how much is it?

Compensation for time and travel is set at a flat rate for each completed visit by the respective study sponsor and thereby varies dependent upon study. The study coordinator will review compensation specifics with you in detail at the time of your screening visit.

Can a participant leave a clinical trial after it has begun?

YES. A volunteer can discontinue participation at any point during the study. When withdrawing from the study, it is extremely important to alert the research team, and provide the reasons for leaving the study. In some cases a final exam before leaving the study can be required and shouldn’t be refused by the participant.

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