Joining Clinical Trials: Why Do We Conduct Clinical Trials? (1)

“I do not want to join your clinical trial because I do not want to be lab rat for you to test your medication on me”

This is not the first time we hear of this reply when we offered patients to join our clinical trial.

Let me be very clear here. Phase 3 clinical trials conducted at our centre are way past pre-clinical trial done on animals (refer below).

Clinical trials
Drug development process

Why do we conduct clinical trials?

Why new cancer drugs are unavailable in Malaysian public hospitals?

Actually, not only new drugs are unavailable; not only targeted therapy or immunotherapy but even standard of care chemotherapy for lung cancer since 2008 are also not widely available now, in 2018, due to cost constrain.

In phase 3 clinical trials, the new study drug/ investigational product (IP) is always compared to ‘Standard of Care (SoC)’ treatment. Patients who participate in clinical trial are randomised into either new study drug/ IP or ‘Standard of Care’ treatment but patients themselves and the doctors won’t know which treatment they are getting to prevent any bias during assessment.

By participating in clinical trials, our patients will have the opportunity to receive new study drugs/ IP or at least the current ‘Standard of Care’ treatment for free.

For example, for stage 4 lung cancer, the standard of care chemotherapy doublet treatment is with pemetrexed (Alimta)/ cisplatin + maintenance pemetrexed.

So, in stage 4 lung cancer phase 3 trial, the new study drug (targeted therapy, immunotherapy, etc.) will always be compared to pemetrexed/ cisplatin, which cost at least RM5k per cycle.

Thus, patients who participate in clinical trials will benefit no matter which study arms (new study drug/ IP or ‘Standard of Care’ treatment) they were randomised to. These will translate into longer survival for our patients, which is our main aim.

Indirectly, we also help in the advancement of cancer treatment while offering huge potential savings in cancer treatment for both patients and government.

Clinical trials allow early access to new and innovative treatments.

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