Drug development –a complicated process

10 years for a new drug

There is hope indeed, but only for those patients who have enough time to wait. Developing a new drug is an expensive and time-consuming process made even more difficult by today’s global recession.

The best current estimate puts the cost of developing a single new drug to 1 billion US dollars! (Drug Discovery World, fall 2010).Furthermore, ever since the drug candidate has entered the screening process, it takes, on average, 10 years for it to reach the market, if it ever reaches the market. Many drug candidates simply do not make it until the last phase of clinical trials.

Animals put first…

To begin, computer modeling techniques are used in order to select from hundreds of different biological compounds the ones that have potential to become drugs. Then, the drug candidate enters the pre-clinical phase. The pre-clinical phase is about invitro studies and simultaneously/latter animal testing.

Of the thousands of potential drugs screened in the pre-clinical phase, only a few will reach the next phase: clinical testing.

Testing on humans

Clinical trials involve administering the drug to human subjects. Human testing is again sub-divided in several steps.

Microdosing or Phase 0 is about giving tiny doses of the drug candidate to healthy human volunteers. These tests focus on how the drug could affect humans in a different way than it affected animals used during earlier stages of the drug development process.

Phase I involves carrying tests on small group of healthy volunteers (usually around 20-80). Phase II allows researchers to test the drug on a larger group of people (100-300 persons) consisting of both healthy volunteers and patients. This phase is supposed to reveal the drug’s most common short-time side effects.

Phase III extends the tests on larger groups of patients with the aim of determining how effective the drug is, in comparison with existing medicine. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials, especially in therapies for chronic diseases, such as cancer. In conditions such as cancer it takes months, if not years, to see if that specific treatment has the expected effect.

After completing phase III, the drug might get permission to be sold. Finally, Phase IV is a surveillance phase that investigates the drug’s possible long-term side-effects.

Eventually, successful drug candidates are supposed to apply for a product license. In the USA, approximately 11% of drugs that begin phase I clinical trails are eventually licensed.

So, going back to the very first phase of the drug developing process, invitro studies, it would be worth understanding what is actually going on in Bilkent University labs at this point of the research.

Irem Durmaz planting cancer cells that will be later treated with the drug candidate.

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