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CLINICAL TRIALS

 

Clinical trials are vitally important in the development of new medications designed to target pulmonary arterial hypertension (PAH). The Scottish Pulmonary Vascular Unit has always had an active research program and has been involved in many of the important clinical trials of these new medicines. We are extremely grateful for the willing participation of patients attending the Unit in these studies.

 

A double-blinded, placebo controlled randomised clinical trial

 

Licensing authorities (the MHRA in the UK) need very good evidence that any trial drug will make an effective PAH treatment.

  • It must be shown that patients who were given a trial drug received a beneficial therapeutic effect that was not seen in patients who do not receive the trial drug. In a clinical trial this is done by some of the patients being given a dummy medicine, called a placebo.
  • You will not be told at this stage what has been chosen for you. Both the trial drug and the placebo will look the same, so there is no way of guessing what you are on.
  • The way it is decided who should be given placebo, and who should be given the trial drug, is done by randomisation, which is like the flip of a coin. This is a random assignment to treatment.
  • Your doctors and nurses are not told what has been chosen for you.
  • This is the double blind, and avoids any unintended bias (for or against the trial drug) so that all results are pure and accurate.

 

New trial drugs undergo rigorous testing before they can be licensed.

  • Before a new drug reaches a patient it has already undergone extensive safety testing in the laboratory, and has been safety tested on human volunteers who do not have PAH, under controlled conditions.
  • There also has to be significant scientific data to show that the trial drug has a beneficial therapeutic effect on PAH.
  • This data is obtained by dosing patients who have PAH with the trial drug. This is done on a small scale to begin with, using small numbers of consenting patients, in early stage clinical trials.
  • Pharmaceutical companies then invite prominent specialists in the field of PAH to participate in the later stage clinical trials of the new drug.
  • Some combinations of PAH drugs are known to work well together. Sometimes pharmaceutical companies run clinical trials to study how a particular combination of PAH treatments can benefit the patient.
  • If you are invited to take part in a clinical trial you will be asked for your consent once you have been fully informed about what the trial entails. It is very important that you read the patient information thoroughly, and discuss your participation with family members or friends. You may wish to involve your GP in your decision. The specialist doctors and nurses at the SPVU will help you in any way they can if you have any doubts or queries about taking part. If you choose not to take part it will not prejudice your normal care.

 

The Scottish Pulmonary Vascular Unit has a dedicated Research Nurse employed to look after patients on clinical trials (Val Pollock) but you will still be looked by the Clinical Nurse Specialists, Agnes Crozier and Alison Curran, and the pulmonary vascular doctors.

 

If you wish to know more about clinical trials in PAH, the doctors and nurses of the Scottish Pulmonary Vascular Unit will be happy to discuss this with you.

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