Frequently Asked Questions

Some people participate in clinical trials because none of the standard/approved treatment options have worked, or they are unable to tolerate certain side effects. Clinical trials provide another option when standard therapy has failed. Others participate in trials because they want to contribute to the advancement of medical knowledge.  All clinical trials have guidelines, called eligibility criteria, about who can participate. The criteria are based on such factors as age, sex, disease (type and stage), previous treatment history, and other medical conditions. This helps to reduce the variation within the study and to ensure that the researchers will be able to answer the questions they plan to study. Therefore, not everyone who applies for a clinical trial will be accepted. It is important to test drugs in the people they are meant to help. It is also important to conduct research in a variety of people, because different people may respond differently to treatments.  Authorities and Ethics Committees worldwide seeks to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials.

Everyone that contribute to clinical trials (authorities/committees/pharmaceutical industry/ clinical staff) works to protect participants in clinical trials and to ensure that people have reliable information before deciding whether to join a clinical trial. Authorities in each country have regulations and guidelines for clinical research to protect participants from unreasonable risks. Although efforts are made to control the risks to participants, some may be unavoidable because we are still learning more about the medical treatments in the study. Clinical trial participants should receive complete and accurate information from researchers about what will happen during the trial. Before joining a particular study, you will be given an informed consent document that describes your rights as a participant, as well as details about the study, including potential risks. Signing it indicates that you understand that the trial is research and that you may leave at any time. The informed consent is part of the process that makes sure you understand the known risks associated with the study.

Clinical trials can be sponsored by organizations (such as a pharmaceutical company), national agencies (such as the Central Hospitals and National Institutes of Health), or individuals (such as physicians or health care providers). The sponsor determines the location(s) of the trials, which are usually conducted at universities, medical sites, clinics, hospitals, and industry-funded research sites.

Participating in a clinical trial can be a way of gaining access to an innovative treatment, especially when there are no other options available. It is also a way to contribute to the development of a particular treatment. If there is a medicine being tested that may be useful for you, your doctor may make this suggestion, but the final decision will always be yours, as the risks of a new treatment are not yet well known.

It is advisable you talk to your family doctor before deciding to take part in a clinical trial, as well as with your family, friends or a representative of a patient organisation. If you want to know more about the research, a doctor involved in the study will be able to give you more information and answer your questions.

No. Most phase III and some phase II clinical trials are randomised. This means that participants are divided into two (or more) groups. One group receives the new medicine and the other, called the control group, receives the currently available standard treatment or, if no alternative is available, a placebo. The placebo is an inert substance, meaning that it does not have any interaction with the organism. This means participants in the study do not know if they are taking the medicine being studied, ensuring that any possible improvement is not due to psychological factors. In some types of studies, even the investigators do not know which treatment has been assigned to each patient until the end of the trial, in order to avoid influencing the interpretation of clinical effects and to minimise bias in the results.

Researchers conduct randomised clinical trials to ensure that results are correct and unbiased. To do this, the patients in the group receiving the new medicine and those in the control group have similar characteristics, such as age, gender and disease stage. Because the patients were similar at the start, the researchers know that if one group performs better than the other, the difference is a result of the treatment itself.