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Clinical trials

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Clinical trials are highly regulated tests designed to determine if a new treatment is safe and effective for a certain disease. They are carried out on people and serve to test both drugs and surgical equipment and operations.

Clinical trials constitute the most suitable way of researching new treatments to prevent, alleviate or fight diseases. The ICO is a referral centre for clinical trials for cancer.

They can contribute to research that could help others. In some cases it is even possible to improve the course of one’s own illness. Patients can feel better or live longer.

All patients that take part in clinical trials are carefully monitored by their doctor during the clinical trial and for a period of time once it has concluded. If tests show that the treatment being researched is better than those already in existence, those patients having taken part in the clinical trial will be the first to benefit from it.

All clinical trials are not without their risks or adverse effects. The doctor will inform the patient of these factors before he or she decides whether or not to participate.

Patients must assess the benefits that the research may provide, both for themselves and future patients, as well as the known and possible risks that they are willing to take.

In general, the doctor is the one who asks if a patient would like to take part in clinical trials, having studied the specifics of each case. However, you can also mention that you are willing to participate in a clinical trial at the centre where you are being treated or any other.

Informed consent is the process through which a doctor informs a patient, in adequate and comprehensible terms, of the clinical trial in which participation is suggested. The risks and possible benefits involved are explained, so that the patient can freely decide if they want to participate or not.

In addition, the patient is given a document containing all the information on the trial, which must be read carefully so that the doctor can be asked any questions and doubts that may arise. If the patient agrees to participate, the document must then be signed. Signing a document of informed consent does not mean that the patient is obligated to follow through until the end of the clinical trial.

Yes. The patient is free to choose to participate in a clinical trial and is also free to abandon the trial when he or she sees fit, without any need to provide an explanation or repercussions for his or her medical treatment.

Every clinical trial must be adapted to the laws protecting patient rights. In Spain, the Medicines Act governs the conditions for carrying out clinical trials, providing patients with maximum guarantees.

The medicine being studied must have been given prior approval by the Ministry of Health, and approval is only given once all requirements for experimentation on animals and healthy volunteers have been met.

Furthermore, each hospital has a Clinical Research Ethics Committee comprising doctors, nursing and other non-health professionals, such as doctors, social workers, and so on, who carefully review the proposed trial and approve or deny it.

Each clinical trial must follow a plan of action called a protocol, which breaks down everything that must be done.

There are trials that intend to determine the safe dosage for a medicine. Others test the effectiveness of new treatments on small groups of patients to decide if it is worth continuing research through more extensive studies. Many compare two different types of treatment on two groups of patients. If an adequate form of treatment already exists, the new treatment is tested against it.

To ensure reliable results, patients are assigned at random to one of the treatment groups (randomization). Sometimes neither the patient nor the doctor knows which treatment has been assigned.

Update:  24.10.2011