What Is a Clinical Trial?

Main Category: Clinical Trials / Drug Trials
Article Date: 27 Jun 2004 - 16:00 PDT


Clinical trials are studies performed with human subjects to test new drugs or combinations of drugs, new approaches to surgery or radiotherapy or procedures to improve the diagnosis of disease and the quality of life of the patient.

Most hospitals now take part in clinical trials, which are only begun after laboratory studies have outlined the potential safety of a new treatment or procedure and that it has the potential to work better than existing methods.

Why do we need clinical trials?

None of the existing treatments result in a cure of all patients, nor are they without side effects, and doctors continue looking for better ways to treat the disease.

What information do we get from clinical trials?

Any new treatment or procedure will be investigated using a whole series of clinical trials, each one designed to answer a specific set of questions.

Clinical trials are also organised into different phases of research, in order to build up a greater understanding of the new treatment, before it is approved or recommended for routine use.

Phase I -

The first studies in humans are Phase I trials. They are performed with small numbers of patients or healthy volunteers and are used to answer questions such as what dose of the drug is likely to be effective and what side effects might occur.

Phase II -

These trials continue this process with larger numbers of patients.They have a greater focus on how well the treatment or procedure works, perhaps in particular situations or groups of patients.

Phase III -

These trials enrol large numbers of patients and are used to compare the effectiveness and safety of the new treatment with that of the standard existing treatment. Information obtained from large Phase III trials that demonstrates the benefits a new drug over the existing treatments is sometimes presented to regulatory authorities in order to obtain a licence to market and sell the drug.

Who organises and runs clinical trials?

A number of different organisations, agencies and companies may be involved in a single clinical trial. For example, the study may be guided by a team of researchers and funded by resources from a public health agency, a research organisation and/or a pharmaceutical company.

The clinical trial is managed by a principal investigator (a medical doctor with considerable experience in research) who leads a research team, composed of other doctors, scientists, nurses, psychologists and other medical and research professionals. A wide range of specialists contributes to the clinical trial design and to the analysis interpretation and presentation of the results.

If you should decide to participate in a clinical trial, before enrolling, you should request a clear explanation of the purpose of the trial and the role of each sponsor.

Before a clinical trial can start the doctors concerned have to explain and justify what they wish to study and how they wish to study it to a supervisory board of other doctors (a so-called Review Board or Ethical Committee). Part of this review body's job is to ensure that your rights are protected, and that the highest standards of clinical practice will be observed.

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