Questions & Answers

What is a clinical trial?

There are many definitions of clinical trials. Most are considered to be biomedical or health-related research studies in humans that follow a defined clinical protocol. All clinical trial participants are observed and their outcomes are measured by the investigators, with this clinical data finally being reported on by the pharmaceutical company as clinical studies progress. The main objective is to develop new drugs which work as effectively, if not more than current ‘gold standard’ drugs already on the market.

Why participate in a clinical trial?

Participants in clinical trials play a important role in their own and other people’s health care. Through participating as a trial subject, each individual tests drugs and gains access to new research treatments before they are widely available. Scientific clinical trials are performed with humans to evaluate the safety and efficacy of new treatment methods. The decision to participate in clinical trial is made voluntarily by the patient and each individual makes their own decision to participate in a clinical trial. The patient signs informed consent form after doctor provides with comprehensive information on possible risks and benefits of clinical trial. Clinical trials are conducted following the rule that the subject’s interests are always beyond the public and scientific interests. Moreover, the subject’s personal rights are secured and his/her safety and well-being are guaranteed as well as assured reliable clinical trial results. Clinical trials are conducted following the Guideline for Good Clinical Practice and ethical principles outlined in Declaration of Helsinki.

Who can participate in a clinical trial?

Everyone can participate in clinical trials, but all clinical trials have inclusion and exclusion criteria which determines who can participate in the study. Each and every trial uses inclusion/exclusion criteria in order to produce reliable and consistent results and data. The criteria that allow a participant to participate in a clinical trial are called "inclusion criteria" and those that disallow a participant from participating are called "exclusion criteria". The in- and exclusion criteria’s are based on factors like; previous treatment, the type/stage of a disease, gender, age and if the subject is taken certain other medication. Before participating in a clinical trial, a participant must be screened in order to qualify for the study. Some research studies seek participants with a specific defined disease, while other studies need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to keep the participants safe.

What is informed consent?

Before a participant can participate in a clinical trial they get Informed Consent (IC). The IC gives the participant the key facts about a clinical trial before deciding whether or not to participate. To help someone decide whether or not to participate, CCBR’s physicians and nurses involved in the trial explain the details of the study and what is expected of the trial subject. The IC must be in the participant's native language. Besides talking to the physician and nurse, the participant is given a document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are also explained in the informed consent document. The participant then decides whether or not to sign the document. It is very important to say that the informed consent IS NOT a contract, and the participant may withdraw from the trial at any time, without giving any reason.

What are the benefits of participating in a Clinical Trial?

• Playing an important role in your own and also other people’s health care by participating in clinical & medical research.

• Gaining access to new treatments before they are available.

• Obtaining expert medical care at CCBRs professional and dedicated research centres during the trial.

• Getting a full ‘Health Check up’

What are side effects?

Side effects are defined as any undesired actions or effects of the experimental drug / treatment. Negative or adverse effects includes; headache, skin irritation, hair loss, nausea or any other physical or physiological problems. Clinical Trials must be evaluated for both immediate and long-term side effects.

How is the safety of the participant protected?

The Clinical Trial follows a protocol, which include a study plan where there are details of what researchers will do in the study. As the Clinical Trial progresses, all results is reported to; scientific meetings, medical journals, and to various government agencies, like; ethical committee, the medicine agency and others. Individual participants' names will remain secret and will not be mentioned in any reports.

What to consider before participating in a Clinical Trial?

Participants should know as much as possible about the Clinical Trial and feel comfortable asking the clinical staff any questions about it.

What kind of preparation before meeting

the physician?

• Write down possible questions to ask the physician.

• Ask a friend to come along for support and to hear the answers to the questions.

• Feel free to bring a tape recorder to record the conversation you can use it to replay later.

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

YES. A participant can leave a Clinical Trial, at any time – without giving any reason for leaving. But it would help the research, when withdrawing from the trial, reasons for leaving the study.

What is a placebo?

A placebo is an inactive pill, liquid, or powder that has no treatment effect. In Clinical Trials, experimental treatments are often compared with placebos to assess the effect of the experimental treatment. In some Clinical Studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment. You will not know weather you receiving placebo or the experimental treatment before study are over.

What is a control group?

In many Clinical Trials, one of the groups of patients will be given an experimental drug or treatment, while the control group is given either the currently treatment for the disease or a placebo.

What are the phases of clinical trials?

Clinical Trials are divided into 4 phases. Each phase have a different purpose and help the research staff answer different questions:

• Phase 1: The experimental drug or treatment is tested in small groups of healthy participants (20-80 participants) for the first time to evaluate the safety, determine a safe dosage range, and identify possible side effects.

• In Phase 2: The study drug or treatment is given to a larger group of participants with the specific disease (100-300 participants) to see if it is effective and to further evaluate its safety.

• In Phase 3: The experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm the effect, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

• In Phase 4: Is called post marketing studies. This kind of study is conducted when experimental study drug or treatment is approved. This phase delineates additional information including the experimental drug or treatment risks, benefits, optimal use and very rare side effects.

If you are interested in participating in this trial, you are welcome to use the "Call Me" feature located at the right side. You can also use this registration form.