Clinical Trials

What is a clinical trial?

A clinical trial is a study performed under the stringent protocol to determine the most effective therapy for any cancer.

Clinical trials that test medications are conducted in phases.

• Phase I determines the safe dosages of a new drug in a small human population.
• Phase II attempts to determine how well people respond to specific treatments. If enough people respond positively, the study may go on to the next level.
• Phase III enrolls many people (sometimes thousands worldwide) to test drug efficacy and safety.
• Phase IV research requires a control group to receive standard therapy while another group receives the new drug.

What are the types of a clinical trials?

There are various types of trials design amongst those; there are two main types:

• Single-arm trials: All patients receive the new cancer treatment in these trials.
• Randomized trial: In this trial, you may receive either newer therapy or either investigator’s choice of drug (older established drug). Randomized clinical trials are divided into two groups based on participants or investigators awareness of the group assigned:
• Single Blind: In this case, you won’t know which group you have been assigned, but the investigator knows about it.
• Double-Blind: Neither investigator nor you will know which group you have been assigned.

Is a Clinical trial accessible in India, and do I have to pay for a clinical trial?

Cancer clinical trials are now accessible in India at specialized cancer centers. These trials provide patients access to the most advanced therapies such as targeted therapy and immunotherapies. Additionally, trial participants do not have to pay the out-of-pocket cost to facilitate such expensive treatment. The sponsor usually pays for all research-related costs and special testing.

How do I know if I’m eligible to join a clinical trial?

Every clinical trial has predefined criteria, which are also termed eligibility criteria. If you meet the following criteria: age, gender, the type and stage of your disease, previous treatment history, and other medical conditions, you are eligible to participate.

What is informed consent?

Before participating in clinical trials, the clinical research coordinator will explain the purpose of the trial, its potential risk, benefits, and information on your data privacy.

If you want to participate, you will have to sign the consent and agree that all the information regarding the trial has been shared with you.

Who makes sure that I’m not harmed while participating in a clinical trial?

All cancer clinical trials in India need approval and monitoring by regulatory authorities approved by the Government of India, such as the Drug Controller General of India and ethics committees. The ethics committee is a group of medical professionals, ethicists, and people from the community who safeguard and protect participants’ rights and welfare.

What are the benefits of participating in clinical trials?

• You will have access to one of the nation’s best researchers, physicians, and clinical care staff.
• You may get earlier access to the newer therapies. E.g., Patients with Stage 4 Lung Cancer who receives chemotherapy tend to survive one year on average, while new novel therapies improve overall survival.
• Your active participation in the trial may result in information that will help others in the future.

What are the disadvantages of participating in clinical trials?

The only disadvantage is there is no assurance that the trial drug is more effective than the standard treatment.

You may have to face some previously unknown adverse effects.

What if I decide that I don’t want to participate in research?

Participation in clinical research is voluntary. You can leave at any time; it is always helpful to the researchers if you tell them why.

What questions should I ask before I take part in a study?

Before participating in the clinical trial; you must gain as much information as you can:

A few of the questions you can ask your coordinator before participating are as follows.

• What is the purpose of this study?
• How will this research help?
• What tests or procedures will be done?
• Will I be asked to take investigational drugs or undergo experimental procedures?
• What are the potential risks and benefits of taking part in the study?
• What other options do I have if I decide not to participate?
• What will happen to the specimens (blood, tissue, or genetic) that I give?
• Who has approved this research?
• What happens if my condition gets worse while I'm in study?
• Who will pay my medical bills if I become sick due to participating in the study?
• Will it cost me anything to be in the study?