Do clinical trials take us a step ahead towards treating cancer?

In India one out of five cancer clinical trials fail due to lack of volunteers. Here is how clinical trials can really help.

Whether it is cancer or any other life-threatening disease, a cure or better management program is what we all need. While clinical trials are always crucial in disease management and constructing a better treatment modality, not everyone is forthcoming to undergo clinical trials. In a webinar conducted by ETHealthworld.com Dr D Raghunadharao, Director, Homi Bhabha Cancer Hospital & Research Centre spoke on defeating cancer through clinical trials. Here are some excerpts of the same:

How clinical trials can help in the treatment of cancer?

The test treatment being evaluated in the trial is found to be better than the standard treatment and so a patient is likely to benefit from a clinical trial. Also, for patients who are willing to undergo a clinical trial, there is always an emotional string attached to it. For instance, when a patient is ready for the treatment he also responds to a placebo. In the case of clinical trials, if you empower the patient about the positive outcomes a person is willing to go for it and that willingness has a positive impact on the treatment outcomes. If the trial benefits the patients undergoing it, in the larger picture it will also benefit other patients too.

How do patients respond to a clinical trial?

The clinical trials are conducted with rigorous protocols and patient safety is of utmost importance. Usually, a patient undergoing a clinical trial or other well-defined studies respond well regardless of what treatment they receive. All trials are closely monitored to check how the patients are progressing with the test treatment.

Is undergoing a clinical trial worth it?

Current evidence suggests that patients might do better in clinical trials. Effectively implemented clinical protocol has the potential to stimulate beneficial effects of trial protocols.

What exactly happens in a clinical trial?

Every new trial has a unique treatment design. A trial is usually designed to monitor the efficacy and safety of the new drug, charting a new course, setting a new standard and treatment approach.

What are the end results clinical trials look at?

The end result is to check the response rate of the treatment, like how many cancers shrinks in patients having a particular treatment. It also evaluates the duration of response like how much time it takes for the cancer to come back or grow. It tests the disease progression like if the cancer continues to grow despite the treatment. The most important is that the trial also takes into account the survival rate of the patient like how well the patient copes with the treatment.

What encompasses a clinical trial?

There are various tests and surgeries conducted to test the drug or the treatment.

Which patients are eligible to undergo a clinical trial?

This depends on the phase and the drug that is tested. If the phase I and phase II studies are done then one knows what to expect from Phase III. Usually, if there are no curative option for a patient going on a clinical trial for a new drug can be advised.

Are there enough patients in India who are ready to go for clinical trials?

No, there aren't many volunteers to take in clinical trials. This is the reason clinical trials are stalled and one in five cancer clinical trials are never completed.

What are the reasons that patients refuse to be a part of clinical trials?

Understand being a part of a clinical trial has its own pros and cons. The toxicity of the drug is being tested and a patient needs to travel to the test center very frequently. This is one of the drawbacks. Also, blood is drawn from the patients very regularly to check for the efficacy and toxicity of the treatment and this is quite a painful experience. Moreover, if the treatment is available by a third party, then a patient might refuse to go for a clinical trial, like, if a person is covered by employee health benefits scheme then he might refuse to undergo a trial.

What can be done to help get more volunteers for clinical trials?

We need to educate three sets of people to make clinical trials more effective,

a. The public in general, who should know that clinical trials are there for their own benefit.

b. Journalists and media who paint a black picture of clinical trials

c. The judiciary who needs also to understand that clinical trials are safe and for the benefit of people.

What if a clinical trial fails?

When on clinical trial a patient is given 120th part of the recommended dose to check for toxicity and efficacy. We don't assume that a patient might die with that dosage. Patient safety is of paramount importance. There are safety protocols that are followed and if a drug or treatment is not doing well it is stopped at an early stage. Still there are people who undergo clinical trials hoping that the studies done on them will help draft better treatment protocols and help another benefit from the same.

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