What is a clinical trial?

A clinical trial is a research study that evaluates the safety and effectiveness of a treatment involving human participants. The treatment in question previously undergoes successful studies in a laboratory (in cell cultures and animals).

Why are clinical trials important?

Clinical trials are essential for proving that a treatment under investigation is effective and safe for use. Safety is assessed by monitoring any side effects that occur during the study. Effectiveness refers to a medication’s ability to produce beneficial outcomes. Furthermore, it’s a legal requirement for the pharmaceutical industry to ensure that all available medications have been tested in clinical trials with favourable results. They also provide valuable information to help healthcare professionals choose the most appropriate treatments for their patients.

How is the safety of volunteers ensured?

Clinical trials do not commence until there is sufficient assurance that the drugs being researched are safe for humans. Before this stage, the drugs must have demonstrated a minimum level of safety and effectiveness in laboratory testing, which is assessed by health authorities before any clinical trial on humans begins. Authorisation from the relevant regulatory agency, which in Spain is the Spanish Agency for Medicines and Medical Devices (AEMPS), is also required to start a clinical trial.

What phases are involved in clinical research?

See image in the PPT. Phase I Trials, Phase II Trials…

How is volunteers’ confidential information handled?

The confidentiality of data collected in clinical trials is regulated by the Spanish Data Protection Agency through the following regulations:

  • Organic Law 15/1999, of 13 December, on Personal Data Protection.
  • Royal Decree 1720/2007, of December 21, approving the Regulation implementing Organic Law 15/1999.
  • Law 41/2002, of 14 November, regulating patient autonomy and rights and obligations with regard to information and clinical documentation.
  • Royal Decree 223/2004, of 6 February, regulating clinical drug trials.

This ensures that clinical trials protect the physical and mental integrity of the subject, as well as their privacy and the protection of their data. Specifically, Article 7, paragraph 3 of the Organic Law on Data Protection states that “Personal data referring to racial origin, health, and sex life may only be collected, processed, and transferred when so provided by a law for reasons of general interest, or if the affected party expressly consents”.

What are eligibility criteria?

Eligibility criteria are the requirements an individual must meet to be included in a trial. These requirements ensure that trial participants share certain specific factors such as age, general health condition, and prior treatment. When the same eligibility criteria are met, it’s less likely that other factors or chance will affect the trial’s outcome.

What is a placebo and the placebo effect?

A placebo is an inactive substance or a substance with no pharmacological activity. It looks the same and is administered in the same way as the medication being tested.

A placebo can have a therapeutic effect when the patient taking it believes it is a pharmacologically active medication. This healing or improvement action is known as the placebo effect.

What is a control or control group?

In a clinical trial, the control group  does not receive the new treatment being studied. It may be given a placebo or another treatment similar to the one being studied.

What is informed consent?

Informed consent is a process by which a subject voluntarily confirms their participation in a specific trial, after being informed of all aspects of the trial relevant to their decision to participate. The risks of participating in the trial are also described in this document. Informed consent is documented using a written, signed, and dated informed consent form. The purpose of the informed consent process is to protect individuals enrolling in clinical studies.

What happens if I decide not to participate or change my mind after the trial has started?

Participation in clinical trials is entirely voluntary. Therefore, any participant can leave a clinical trial at any time.

If you decide to withdraw from the trial, you must inform the research team and explain the reasons for leaving the study.

Can I continue taking my usual medication during the trial?

It depends on the trial. You must inform the study team about all the medications you are currently taking so they can decide if there is any potential risk of negative interaction or if it could affect the study results. They will tell you whether you can continue taking your current medication or if the trial is not suitable for you.

Will I be paid for participating?

Compensation varies depending on the trial and the country. Generally, patients are not paid for participating, but expenses may be covered. However, there are occasions when payment is offered for participation, especially in phase I trials. The research team will clearly explain any compensation offered during the informed consent process.

Should I participate in a clinical trial?

It’s always the volunteer’s decision to participate in a clinical trial after reading and understanding an informed consent form. You will also undergo thorough medical monitoring to ensure your health is not compromised at any time, including consultations with the specialist doctor.

Participating in a clinical trial promotes collaboration in the development of new treatments for future generations. Moreover, volunteers participating in a clinical trial can leave the study at any time if they wish.

Who is involved in a clinical trial?

Volunteers or patients: they are at the core of a clinical trial, without whom the rest of the patients would not have access to new treatments approved in the future.

Ethics Committees: ensure the protection of the rights, safety, and well-being of the subjects participating in clinical trials.

Regulatory Agencies: review and approve all documentation related to a clinical trial, to grant the authorisation to market the medication in a country or region.

Healthcare and research personnel: conduct the clinical trial, evaluating the response to the medication.

Sponsor: designs and promotes the development of the clinical trial and is ultimately responsible for the study.