Joining Clinical Trials: What Do You Gain? What Do You Lose? (2)

In overseas, cancer patients travel from one state to another just to participate in clinical trials that is not available at their home state.

Why? This is because they realised the immense benefits of their participation in clinical trial.

In Malaysia, patients are not aware of the benefits of clinical trial. Instead, they rather believe in someone who sells them supplements, herbs and alternative ‘one-medicine-treats-all-diseases’ fake remedies.

What do you gain?

By taking part in clinical trial, patients will have quicker access to newer therapies (if randomised to new study drug/ investigational product) that might take years of research before obtaining regulatory approval for commercial use.

Some patients who participated in immunotherapy clinical trials for stage 4 lung cancer many years ago are still alive today, despite studies with older drugs showed that they should be dead 2-3 years ago with older treatments.

It will take even longer time for the new treatment to arrive at the shores of our country and when it arrives, it will be too costly for most people.

Even if patients are not randomised to new study drug/ investigational product (IP) treatment arm, patients will still get ‘Standard of Care (SoC)’ treatment.

Patients are NOT getting inferior treatment but standard treatment as per recomendations from international guidelines like NCCN, ESMO, etc.

In phase 3 clinical trial, the new study drug/ investigational product (IP) is always compared to ‘Standard of Care (SoC)’ treatment.

Also, when you join clinical trial, the treatment is FREE for both the new study drug/ investigational product (IP) and standard of care treatment.

For those participating clinical trial in private hospital, the consultation charges is WAIVED as it is covered by the clinical trial.

There are strict monitoring of the disease in clinical trial. So, you can expect to know the treatment progress at regular intervals with repeated blood investigations/ tumor markers and CT/ MRI scans.

We even send patients to get the investigations done at private hospital/ labs as it is much quicker.

What will it cost patients for all the repeated blood investigations/ tumor markers and CT/ MRI scans? FREE. The clinical trial covers all the cost.

The initial total price for pembrolizumab use in stage 4 lung cancer was RM1000000 (RM1 juta) for two years course of the treatment. Mind you, the medication already had good data in earlier phases (1, 2) stage 4 lung cancer and in other tumor sites (melanoma).

Not to mention also that you will be reviewed by specialist (or senior registrar/ MO who are involved in the study) at every single visit, getting every single complaint of yours looked into (to see if it’s related to the treatment), have ‘elaun tambang’, ‘elaun makan’ and have study coordinator calling you to remind you about your appointment with the doctor.

At any point of time, patients can choose to withdraw from clinical trial if they want to.

What do you lose?

The new study drug might not be more effective (or less effective, in rare cases) than the standard of care treatment.

It is rare because pharmaceutical companies need to invest huge amount of money in every phases of clinical trial and unless results are promising, it will be terminated from going into last phase 3 study, which cost most money to them.

There might also be newer side effects that doctors are not yet familiar with.

That is why consultation with the doctor is very detail and time consuming during clinical trial.

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