What is a clinical study?

What is a clinical study?

A clinical study is a study with patients and/or healthy volunteers that is done to evaluate whether a new treatment is safe and if it works. Clinical studies are performed to test the effectiveness of medications or of the combinations of various treatments.

Scientific research and clinical studies are essential for developing and optimising medical treatments and techniques. After all, no new medication or treatment is used before extensive studies have demonstrated that this new product or treatment is effective and safe.

Advantages of a clinical study

Advantages of a clinical study
  • Considering that certain clinical trials give participating patients access to the newest treatments before they are available on the market, patients gain access to the latest scientific advances. This sometimes provides a new chance for recovery or an increase in quality of life. During a clinical study, you are monitored very closely in order to detect every effect of the tested treatment.
  • By participating in a clinical study, you are first and foremost in solidarity with the generations of today and tomorrow. You can take pride in this, and you are certainly appreciated for this. Your participation can contribute toward better care in the future.
  • Participating in a clinical study represents an important act of global solidarity, as the knowledge and experience gained from these trials is shared internationally. This is how medicine evolves beyond our country's borders.

Source: www.klinischeproeven.be

Disadvantages of a clinical study

Disadvantages of a clinical study
  • Since a clinical study is meant to answer a question regarding a new treatment, there is no guarantee yet that this medication or method will be effective.
  • There is, depending on the type of clinical study, no guarantee that you will receive the studied medication or that you will have the studied procedure performed. You may be given a placebo or you may receive the current standard of care, and, for this reason, may not experience the benefits during or after the clinical study.
  • Since the treatment is experimental, the participants may also experience unexpected side effects. Even before starting the study, measures are taken to prevent and remedy any known possible risks. Clinical studies are monitored closely in order to detect and prevent these side effects as quickly as possible. Every participant receives follow-up for a specific medication.
  • In comparison with a standard treatment, participation in a clinical study can involve a more intensive care trajectory. There may be extra consultations, tests and treatments, which can require extra time and consideration on your part. It is the responsibility of the researcher to inform you, as the patient, of these details.

Your rights and obligations as a participant

Your rights and obligations as a participant

As a participant, you have the right to:

  • participate voluntarily, without pressure or negative consequences if you choose not to participate;
  • exit the study at any time;
  • treatment, free of charge, using the studied medication and to routine medical tests, also free of charge, related to the clinical study (if it concerns study interventions);
  • reimbursement for any transport costs incurred;
  • all necessary information to be able to give consent to every procedure;
  • clear and understandable responses to your questions;
  • be immediately informed when there is new information that could impact the decision to participate, even after the study has already started
  • have care administered in a safe manner;
  • have your information handled in a confidential and anonymous manner;
  • insurance that is paid by the leading researcher for the study.

As a participant, you are obligated to:

  • provide true and complete information about your health status, prior medical history and any treatments you have received;
  • comply with the clinical study protocol and to work with the medical staff;
  • to follow up with visits and accompanying evaluations, which can be quite intensive.

Source: www.klinischeproeven.be

You are insured against risk

According to the law of 7 May 2004 regarding experiments involving human subjects, the organiser (also referred to as the principle researcher) of the clinical study is obligated to provide ‘no fault’ insurance. Any damage that the participants (directly or indirectly) experience due to the clinical study is always reimbursed by this insurance, even if the responsible physician has not committed any error.

Source: www.klinischeproeven.be

'Informed consent'

Before you decide whether to participate in a clinical study, you will receive all relevant information about the course of the study, the advantages, the disadvantages, the risks and the alternatives of the study in an understandable format.

Written consent

In order to effectively participate, you will need to provide your written consent using the 'informed consent' document designated for this purpose.

The ‘informed consent' is the consent document that contains all the details about the study, such as:

  • our goal
  • the duration
  • the required procedures
  • the risks and possible benefits of a particular study
  • the contact persons

Your participation is voluntary

There will absolutely not be any pressure whatsoever to convince you to participate. If a physician asks you to participate in a study, you may refuse, without any further explanation. You do not need to provide any reason, and refusal will not influence your subsequent treatment or your relationship with your physician. It is important that your participation be completely voluntary and that you have the necessary time to inform yourself, to discuss your participation with your family, your GP, etc.

You can stop whenever you wish

Even after having agreed to participate, you can always decide to stop participating in the study or to refuse certain treatments that are part of the study. This may mean that you are no longer a candidate to continue participating in the study.

When the researcher stops the study

The researcher can also decide that you may no longer participate in the study. This can happen, for example, if there is a change in the treatment trajectory or after certain side effects, such as an allergy, arise.