tctMD

What's a clinical study?

A clinical study is any research activity that centers on human beings.

There are two fundamental types of clinical studies: 1. Observational studies - those in which the characteristics of a group of people are registered and analysed, without any intervention by the researchers in the assessment of that group. Example: studies of the evolution of the disease (natural history of the disease).

2. Clinical trials - those in which an intervention carried out on a group of individuals is evaluated. This intervention can be a drug, medical device or behavioural intervention. Drug clinical trials make it possible to assess the efficacy, safety and dose of new drugs. They are always carried out after a pre-clinical phase in which the drugs are evaluated in the laboratory and on animals.

Example: studies that lead to the approval of drugs and vaccines.

What do I get if I take part in observational studies or clinical trials?

In Portugal, participants in clinical trials or observational studies do not receive any monetary benefit for their participation. However, it is scientific research that leads to new therapeutic options, strategies and drugs.

What are the risks and benefits of taking part in clinical studies?

Clinical studies are carried out in such a way that participants undergo as little risk as possible.

There are written rules that researchers are obliged to comply with, which have to do with the confidentiality of the data obtained, the safety of the participants and the reliability of the research.

In drug clinical trials, the safety of participants is the most important value of all. Therefore, studies are designed, described in a detailed document (protocol), proposed to regulatory authorities and, once approved, candidates are invited to take part.

Any clinical study requires a detailed informed consent, which must be signed and dated by the participant and the researcher proposing the study. The informed consent describes the risks associated with the participation in the study. And this is an act of free and informed choice, the sole responsibility of the participant.

In drug clinical trials, the known side effects of the product being investigated must be described. And the participant, when offered a study, must be informed of these in detail.

Existem riscos associados à investigação. Se por um lado, não se conhecem todos os riscos dos produtos de investigação, por outro, não se podem garantir efeitos benéficos.

There are risks associated with research. Not all the risks of the products being studied are known and beneficial effects cannot be guaranteed.

Participating in a clinical study is a selfless individual contribution to a common good.

Science allow us to increase diseases' knowledge, discover newdrugs and therapeutic alternatives.

Can I refuse to take part in clinical studies?

Yes, if you don't feel comfortable taking part in the proposed study, you should refuse. Under no circumstances should your refusal have any repercussions on the care, treatment and follow-up of your illness.

What is the informed consent?

The informed consent is a document that must be read and understood before agreeing to take part in any study. This document explains to the prospective participant the type of study they will be taking part in, the details of the protocol, the purpose, the risks and who the researchers are. Whenever necessary, the proposing investigator will provide additional clarification to the prospective participant. All informed consents are previously approved by an ethics committee. Consent is signed by the study candidate, or their legal representative, and the proposing investigator. The consent must be dated by the candidate and the researcher. Only after this step can any procedure associated with the study be carried out.

Can I quit a study after its start and having signed the informed consent?

The participant has the right to stop taking part in a study at any time. There are no consequences in terms of follow-up, treatment or interaction with the medical team treating you arising from this decision.

Author GEDII's President: Paula Ministro

For more information, you can visit the Portuguese and European pacient associations' sites: