Development of a drug

Development of a drug
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  1. 739,000,000 Euros of investment
  2. 7,000,874 working hours
  3. 6,587 experiments
  4. 423 researchers
  5. 1 drug

From the discovery of a promising agent to the time when a doctor can prescribe a new drug to his patient, 10 years will pass on average. By this time, it has taken many steps of development. First, effectiveness and safety of many active agent candidates are testes preclinically. The goal is to select optimized substances that can be tested on humans afterwards. The following three clinical study phases are the actual practical test for the candidates. In this time, they have to be proven regarding effectiveness and tolerance in humans. Only a substance that has successfully gone through a phase will be further tested. Phase I tests the effective agent on healthy test persons regarding metabolism, tolerance and safety. In order that the study subjects get the best treatment possible, these studies take place in specialized hospitals or special research institutes. The researchers get first knowledge about the action of the effective agent in the human body and its effects on the organism. In Phase II, the substance is tested for the first time on patients for effectiveness, tolerance and dosage. The researches divide the patients into pre-set groups and give them different dosages of the agent. This way, the gather knowledge if the desired therapeutic effect settles in, about the therapeutic dosis and possible adverse effects. In phase III- studies, the crucial data for the effectiveness on many patients that are required for the release of the drug are determined. They also observe and document adverse effects and interactions with other drugs. The substance is tested either against a placebo or another comparative drug. Which patient gets which agent is decided by chance. After phase III, all the study results are handed in to the admission board for assessment. In Germany, the European Medicines Agency (EMA) is responsible for that. The scientific assessment of the application papers is carried out by the Committee for Medicinal Products for Human Use (CHMP), which is holding meetings monthly. The CHMP committee then prepares a report and gives a recommendation. In the case of a positive release recommendation, the next instance is EMA who, based on this, publishes a final evaluation report. Just after that, the drug can be released for the market in Europe. After the approval of a drug, further studies for finding answers to special questions like eg. the further benefit/risk assessment in multimorbid patients can be conducted in phase IV. If this results in new knowledge, it has to be reported to the authorities and evaluated by them. This procedure called “pharmacovigilance” can lead to the information on the package leaflet be adapted to the latest knowledge. From the first ideas of the researchers to the approval of a preparation by the authorities, on average 739,000,000 Euros are invested. On average, 423 researchers take part in the development of a drug. They use up to 7 million working hours and conduct 6,500 experiments before the doctor can prescribe a patient the new drug.

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 - Uploaded at 09.11.2012
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