Would you like to take part in a clinical trial?

ABOUT

Information about clinical trials.

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REQUIREMENTS

Requirements to be a healthy volunteer

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EQUIPMENT

Equipment and rules

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TAKE PART

How to take part in a clinical trial

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CONTACT

Contact details, location and how to get here

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INFORMATION ABOUT CLINICAL TRIALS

What is a clinical trial?

It often takes more than 12 years of research and development before a new drug arrives on the market, going through an extensive testing process to make sure it is safe and effective. It is only in the final steps of this long process that human clinical trials are conducted.

According to the Royal Decree on Clinical Trials in force in Spain, the definition of a clinical trial is "All research carried out on human beings to determine or confirm clinical, pharmacological and/or other pharmacodynamic effects, and/or to detect adverse reactions, and/or to study the absorption, distribution, metabolism and excretion of one or more research drugs in order to determine their safety and/or efficacy".

Participants (healthy volunteers and patients) are indispensable for clinical research. Without them, a new drug could not be developed or improved.

 What are the phases of a clinical trial?

Phase I Clinical Trials: Studies that are tested on a small number of subjects, usually healthy volunteers. They generally involve the first administration in humans, and the main objective of the studies is to detect drug-related toxicity. In addition, the behaviour of the drug in the body is studied as a secondary objective. The bioequivalence tests that we conduct in our Clinical Trials Unit are also Phase I and serve to market the same active ingredient in the same pharmaceutical formulation as the one previously marketed, the patent for which has expired.

Phase II Clinical Trials: In this second phase, the main objective of studies is to determine the efficacy and safety profile in a small number of patients (100-200 subjects) suffering from the disease for which the drug is being developed. Secondary objectives are finding the optimal dose and administration interval in these patients.

Phase III Clinical Trials: These studies confirm the efficacy and safety data obtained in the previous phases and are therefore carried out on a larger number of patients. This is the phase prior to the regulatory authorities' evaluation of the benefit/risk balance in order to approve its commercialisation.

Phase IV Clinical Trials: These studies are carried out once the drug is marketed and used in normal clinical practice, the main objective being the monitoring and detection of possible adverse reactions related to taking the drug, as well as evaluating long-term effectiveness.

REQUIREMENTS TO BE A HEALTHY VOLUNTEER

  • Over 18 years old and generally no older than 55 years old.
  • Non-smoker.
  • Not taking any abuse drugs (cannabis, cocaine, opioids, amphetamines, etc.)
  • Not suffering from a chronic disease.
  • Not having taken part in a clinical trial in the last three months.
  • Not undergoing chronic treatment, nor having taken prescription medicine or treatment for the 15 days leading up to the trial.
  • Not having donated blood in the month before participation.
  • Not taking herbal products during participation.

EQUIPMENT AND GENERAL RULES

We encourage you to bring things that will help you to pass your free time while you are in hospital. We would like to remind you that if you are going to use mp3 players, DVDs, etc., you must use them with headphones to avoid disturbing your fellow participants.

The unit has the following entertainment equipment:

  • TV (with USB reader)
  • DVD
  • WiFi
  • Board games

Respect and good behaviour are essential, as you will be part of a group of people participating in a clinical trial. During your stay in the Clinical Trials Unit, we ask that you behave accordingly in order to maintain a pleasant and welcoming atmosphere.

Further details of the operating rules will be given to you during your admission.

HOW TO TAKE PART IN A CLINICAL TRIAL

Before the study

Selection Visit

During the selection visit, you will be given the procedures required by the clinical trial protocol prior to your participation to ensure that you meet the requirements set out in each trial protocol.

During admission to the Clinical Trials Unit

For most studies conducted by the Department of Clinical Pharmacology, you will be admitted for 24 or 36 hours.

You will receive the trial medication and then you will begin to have blood samples taken. The number of blood samples taken, as well as any other tests performed during admission, will have been explained to you during the information meeting prior to your participation.

After admission to the Clinical Trials Unit

After admission, an analysis and medical tests will be conducted, as well as an interview with the doctor to close any adverse event that may have occurred during the study.

In a few days, at the end of the study, you will receive a bank transfer of the total amount for your participation in the Clinical Trial.

The study will be compensated proportionally to your participation in the clinical trial and if you do not complete the study you will not receive the total amount, but only the proportional part. This compensation will be made by bank transfer.

For your safety, we would like to remind you that you must allow a reasonable period of time between taking part in some studies and others. If you have taken part in other trials previously, take into account the completion date.

CONTACT DETAILS, LOCATION AND HOW TO GET HERE

The Clinical Trials Unit is located in the Hospital Universitario de La Princesa, on the 7th floor.

Unidad de Ensayos Clinicos Hospital Universitario La Princesa

Department of Clinical Pharmacology 7ª Planta

C/ Diego de León 62.

28006, Madrid, Spain.

Telephone: +34 915 202 247

@UEC_Princesa
Lines 26, 29, 48, 52, 56, 61, 72, 73, 115, C1 and C2
Diego de Léon L4, L5 and L6
Estación Bicimad 144; C/ Juan Bravo 50