Ethical concern and associated with Oncology Clinical Trial

Cancer is arguably the most fatal disease. It is estimated that one third of drugs under discovery or development are for Oncology, but still cancer is almost incurable. Many Cancer Drugs are themselves carcinogenic or toxic. So unlike other therapeutic area’s, it is unethical and unsafe to include healthy volunteers for non-therapeutic oncology clinical trials. That is the reason why non-therapeutic clinical trials are being conducted on patients who are already suffering from this disease, but I am not sure if it is ethical to keep even cancer patients on sub-therapeutic dosage.

There are lots of developments which are taking place around the globe to reduce the timeline and number of patients, which eventually reduce the risk & pain involved during non-therapeutic oncology clinical trial. One such development is Phase 0 clinical trials, which is developed in response to the United States Food and Drug Administration’s (FDA) recent exploratory Investigational New Drug (IND) guidance, to expedite the clinical evaluation of new molecular entities. It involves lesser number of patients for shorter duration and also promises to shorten the duration of non-therapeutic trial by three to six months, i.e. the timeline for taking anticancer drugs from the laboratory to the clinic. Unlike Phase I clinical trials which are designed to establish the MTD, the Phase 0 clinical trial’s maximum dose can be that at which a PK/PD response is observed or target modulation is measured, providing that no drug-associated toxicity is found. Although it does not give any Patient benefit but it gives a flexibility to conduct Phase 1 Clinical trials at much higher dose and with less patient population.

Another significant development which took place is modified study design. The designs which are more or less in use are Accelerated Titration Designs and simulation study designs. Current phase I trials often take a long time to complete and provide little information about inter-patient variability or cumulative toxicity. These designs are developed to get the necessary information by reducing the number of patients and duration in non-therapeutic Oncology clinical trials (http://linus.nci.nih.gov/~brb/AcceleratedTitration.pdf).

Still these developments will not eliminate the suffering a patient volunteer may endure in non-therapeutic trials. Although these study designs promise that the duration of risk will be less or the number of patient volunteers involved in such studies will be less, it can not be eliminated. The main problem in drug discovery & development of oncology drug is unavailability of laboratory methods which can accurately predict which entity will be effective against a particular class of human cancer.

The patients who are suffering from such a painful disease get involved in clinical trials for a variety of reasons, which I believe is unethical. However, the conduct of non-therapeutic Oncology clinical trials is necessary for the advancement of healthcare in society. Hence I believe that the conduct of non-therapeutic clinical trials is a necessary sin, which Pharma companies & CRO have to indulge in for the benefit of society.

Dhirendra V. Singh,

Business Development Manager,

Vedic Lifesciences Pvt Ltd

bizdev@vediclifesciences.com