Frequently asked questions
The main objective in a clinical trial is to develop new and better medical treatments for specific diseases, by evaluating new treatment options on patients or healthy volunteers. All clinical trials are following a defined clinical protocol, which means guidelines to how the trial must be conducted. All participants in Clinical Trials are observed and under continuous care of qualified specialist team (physicians and nurses) during the trial period. The results of the clinical trials are collected by the specialist team, and this clinical data is reported on by the pharmaceutical company as clinical studies progress.
What is a Clinical Trial at CCBR Clinical Research?
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. Criteria that allow a participant to participate in a Clinical Trial are called "inclusion criteria" and those that prevent a participant from participating are called "exclusion criteria". All trials are using inclusion/exclusion criteria in order to produce reliable and consistent results and data. The in- and exclusion criteria are based on factors like; previous treatment, the type/stage of a disease, gender, age, and if the participant is taking certain other medication. Before joining a clinical trial, a participant must be “screened” in order to qualify for the study. Some research studies are seeking participants with a specific defined disease, while other studies need healthy participants.
What is an Informed Consent?When a person decides to participate in a Clinical Trial, he/she must sign an “Informed Consent” document containing information about the Clinical Trial. In this relation the physician provides information about possible risks and benefits and what is required by the participant during the Clinical Trial.
The participant then decides whether to or not to sign the Informed Consent. It is very important to emphasize, that the Informed Consent IS NOT a contract and that the participant may withdraw from the trial at any time, without giving any reason.
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. Of course it would be helpful to the research, if the participant inform about the reason for leaving the study.
How is the participant protected in a clinical trial?The participant’s safety is paramount and beyond the public and scientific interests of the trial. All participants are under continuous care of qualified specialist teams (physicians and nurses) during the trial period.
The Clinical Trial follows a protocol, which includes a study plan that describes 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 Committees, the Medicine Agency and others. The names of the participants will remain secret and will not be mentioned in any reports.
Preparatory measures before meeting the physician?
- Write down possible questions to ask the physician
- Ask a friend or family member to come along for support and to hear the conversation
- Feel free to bring a tape recorder to record the conversation - you can use it to replay later
A placebo is an inactive medication that has no treatment effect. In some Clinical Trials, experimental treatments are compared with placebo to assess the effect of the experimental treatment. In Clinical Trials which uses placebo, the participants in the control group will receive a placebo instead of an active drug or experimental treatment. The participants do not know whether they are receiving placebo or the experimental treatment before the trial is completed. The use of placebo is important in a Clinical Trial for testing the effect of an experimental treatment. Correct information about an experimental treatment cannot be obtained without the use of placebo.
What is placebo?
What is a control group?In many clinical trials, one of the groups of participants will be given an experimental drug or treatment, while the control group is given either approved standard treatment for the disease or a placebo. This is done in order to compare the effect of the experimental treatment to existing treatments on the market or to compare the effect of the experimental treatment if the participant receives no treatment – namely placebo.
What are the phases of Clinical Trials?Clinical trials are divided into 4 phases. Each phase has a different purpose and helps the research staff to answer different questions:
- Phase 1: The experimental treatment is tested in small groups of healthy participants (20-80 participants) for the first time to evaluate safety, determine a safe dosage range, and identify possible side effects
- In Phase 2: The experimental 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 treatment is given to large groups of people (1.000-20.000) to confirm the effect, to monitor side effects, to compare it to commonly used treatments and to collect information that will allow the experimental treatment to be used safelyPhase 4: This kind of study is conducted when the experimental treatment is approved and on the market. It is important to identify the impact of the new treatment in the long term. Therefore this phase delineates additional information including treatment risks, benefits, optimal use and very rare side effects