Might just be my imagination but it seems to me that Mr. Nathanielsz is deliberately avoiding conducting human trials. Phase 1 clinical trials only involves a small test group to determine if the drug has any potential benefits or negative side effects. Naturally if the drug proves ineffective Mr. Nathanielsz wouldn't be able to justify the compensation package he currently receives(salary, bonuses, car allowance, pension package, rental allowance, etc.)
Phase 1 is sometimes written as phase I. They are usually small trials, recruiting only a few patients. The trial may be open to people with any type of cancer.
When laboratory testing shows that a new treatment might help treat cancer, phase 1 trials are done to find out
How much of the drug is safe to give
What the side effects are
How the body copes with the drug
If the treatment shrinks the cancer
Patients are recruited very slowly onto phase 1 trials. So although they don't recruit many patients they can take a long time to complete. The first few patients to take part (called a cohort or group) are given a very small dose of the drug. If all goes well, the next group have a slightly higher dose. The dose is gradually increased with each group. The researchers monitor the effect of the drug until they find the best dose to give. This is called a dose escalation study.
In a phase 1 trial you may have lots of blood tests because the researchers look at how the drug affects you. They also look at how your body copes with, and gets rid of the drug. They record any side effects.
People taking part in phase 1 trials often have advanced cancer. They have usually had all the treatment available to them. They may benefit from the new treatment in the trial but many won't. Phase 1 trials aim to look at doses and side effects. This work has to be done first, before we can test the potential new treatment to see if it works.
