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CLINICAL RESEARCH

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.

Clinical trials information 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.

Clinical trial: 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.

Clinical trial: 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.

Clinical trial: 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.

Organisation of clinical trials 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.

Participation in clinical trials Should I participate in a clinical trial?

There are advantages and disadvantages to taking part in a clinical trial.

Advantages - you will be cared for by doctors who are familiar with the latest information about treatment and you will be monitored very closely. If the treatment being tested is beneficial you could be one of the first to benefit from it. Particularly if you are not responding well to the current therapies, a clinical trial might give you access to an alternative that will work better.

Disadvantages - new drugs and procedures can have unexpected side effects or prove to be less effective than the existing procedures, and even if the procedure works well for many patients, it may not work well for you. The careful monitoring required in a trial can mean more visits to the hospital and more testing than would be necessary outside of a trial, and this may prove disruptive to your life.

As with all issues regarding health and medical care, the decision to take part in a clinical trial should be reviewed carefully and discussed in detail with your doctor. It is important to learn as much as possible about the specific treatments under investigation and how appropriate these are to your particular case. You should be prepared to ask your doctor about the possible risks and the possible benefits that you may get from the treatments being offered in the trial.

It should be remembered that in most trials the different treatments are allocated randomly to the patients who enroll and neither you nor your doctor can choose which one you receive. Furthermore, most trials are also conducted ‘blind’ and neither you nor your doctor will know which of the treatments you are receiving until the end of the trial. If, at the end of the trial one treatment is found to be better than another, the opportunity to move onto the better treatment may be discussed with you, if it was not the treatment that you were receiving during the trial.

Can I change my mind after I have enrolled in a clinical trial?

You will never be enrolled in a clinical trial without being asked first and also having given written consent to take part. However, you can, for any reason, decide not to continue to take part in the trial and your doctor will then offer you the existing treatment for your particular condition.

You can withdraw from a clinical trial, without explanation, at any time.

Clinical trials confidentiality Will the information about me from the clinical trial remain confidential?

The information from the trial, including your personal case notes, will need to be checked by the people running the trial. They, in addition to the doctors at your hospital, may include a number of other specialists, people from the pharmaceutical company who produce the test treatment, and possibly people from the national drug regulatory organisations.

However, all your personal details will be kept strictly confidential and you will be identified in the trial only by a code number and not your name.

There are many institutes in India imparting education in clinical trial. Students with pharmacy and biotech background should go in for such education.