What are Clinical Trials

Clinical trials are medical research studies done to enable doctors to find new and more effective tests, drugs and treatments.

What are the tools needed for a clinical trial

For a clinical trial to be done, the following are needed.

Investigator-An investigator is a person responsible for conducting the clinical trial.

Patients-Patients are needed in a clinical trial to test a new investigation, drug or treatment

Drug or treatment- When a new drug is being tested in a clinical trial, it has to be available to be given to the patients. Some trials compare a standard drug to a new drug and both drugs should be available in that context

What are the different phases of Clinical Trials

Clinical trials can be divided into different phases. Each phase of a clinical trial has different roles and some roles overlap between phases.

Phase 1 trial

A phase 1 trial is one where a new drug is first tested on patients. The aim of this trial or study is to find out the right dose to be given to the patient for that drug balancing the side effects of that drug.

The trial helps to study how the drug behaves in the body and what side effects it produces.

Phase 1 trials are usually done in a small number of patients and in a step wise manner. The dose of the drug may be increased gradually in each of the steps depending on the side effects. Phase 1 trials are offered to patients only when all their standard treatment options have been used as the drugs tested in this phase have not yet been shown to be beneficial.

Phase 2 trial

A phase 2 trial is done on a drug after it goes through a phase 1 trial first. Here, more information is gained about the drug including whether the drug is working for a particular cancer or not. More information about side effects can be gained in this phase too. Generally, more number of patients are included in a phase 2 study than a phase 1 study and sometimes the study drug is compared against another drug or a placebo. A placebo drug is one that looks like a drug but does not contain the active ingredient. If a phase 2 trial is successful in showing that a drug works, then a phase 3 trial is done.

Phase 3 trial

A phase 3 trial is done on a larger number of patients and can range from hundreds to thousands of patients. This trial aims to compare a new drug against an established drug in the treatment of a condition. If the new drug is found to be better than the standard drug, then the new drug is likely to become the standard of care. A trial usually has at least two arms or groups, one being for new drug and other for standard drug, but there can be multiple arm trials testing multiple combinations at once against a single standard option. A single Phase 2 or 3 trial can be done simultaneously in different centres in one country or many countries around the world.

Phase 4 trial

A phase 4 trial is sometimes done. This trial is done after a new drug has been approved or licensed to be used. The trial looks at side effects, efficacy in a larger setting when the drug is used in common practice.

What are the types of Clinical Trials

Clinical trials, apart from different phases can be of different types

Randomised trial

This is a type of trial where the patient is allotted one arm of a study randomly and the patient or investigator has no choice as to which arm the patient falls to. Usually, a computer allocates one arm to the patient. Randomisation is done to make sure the arms of the trials are equally matched and there is no bias in the selection.

Blinded trial

A blinded study is one where the patient (single blinded) or patient and doctor (double blinded) are not aware as to which drug they have been given. This can be standard drug or the trial drug or a placebo. This type of study also aims at removing bias.

Do I have to pay to take part in a clinical trial

You do not have to pay any money to take part in a clinical trial. The company or hospital that is running the trial usually pays for the trial drugs and any scans or tests that are needed as part of the trial.

What are the patient rights and privileges when taking part in a trial

• Patients have a choice as to whether they want to take part in the trial or not
• Patients have a right to full information of the trial, including all the potential side effects of the drugs
• Patients have a right to withdraw from the trial at any point
• As mentioned above, patients need not pay any money for the trial drugs
• Patients have to sign an informed consent. An informed consent is a process where the patient gives a consent for treatment after knowing about all the information about the treatment
• Any side effects or toxicity that happen to the patient must be managed by the trial team

When is a clinical trial offered to the patient?

A clinical trial can be offered to the patient in various settings which are listed below.

• When all standard treatment options are used and no other treatment options are left and the patient still needs treatment to try and control the cancer, a new experimental drug can be tried
• When a new drug is shown to be beneficial and needs testing against a standard treatment, a clinical trial is done to compare the two drugs.

Are patients paid to take part in Clinical Trials?

Usually patients are not paid to take part in clinical trials. There may be some trials where financial incentives are given to patients but generally not.

What are the benefits of taking part in a clinical trial?

There can be various benefits in taking part in a clinical trial. These could be

• Getting access to a new drug that is not yet available in the market
• Getting drugs free of cost that the patient may have to pay for outside of a trial
• Getting access to various investigations such as scans etc free of cost that are part of the trial
• Getting seen more often than usual by a doctor as part of the trial
• Having the possibility of more treatment options when standard options have been used

What types of treatments are involved in Clinical Trials

Clinical trials can be done on all forms of cancer treatments such as Chemotherapy, Immunotherapy, Biological therapy, Surgery and Radiotherapy. Sometimes, trials are done on supportive treatments of cancer rather than cancer treatments. Trials are done on symptoms, social and psychological impacts of diagnosis or treatments of cancer too.