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Along the road there are many bumps and dangers that pharmacists can face in developing a new drug. Registration is also a complicated and time-consuming process. After enrolling in EMA, the European Medicines Agency moving from London to Amsterdam in 2019, there must be country-by-country agreements with insurers on return. This means that it takes a long time for patients to have access to new medicines that ensure efficacy and safety.
Research
Scientific research on the cause and consequences of a disorder sometimes leads to information about possible drugs. These are first extensively tested in the laboratory with cells, computer models and isolated tissues. The vast majority is decreasing.
Preclinical test
The potentially active substances are finally tested in animal cells and experimental animals to better understand their mode of operation and possible side effects. We are also thinking about the production process. One or a small number of candidate drugs remain for clinical research.
Phase I: healthy volunteers
To be accepted as a medicine, resources must be tested extensively in humans. During Phase 1 of the clinical trial, the drug is tested for safety in up to 100 healthy volunteers. How is the result and what is the safe dosage?
Phase II: Patient trial
During the second phase it is time: the potential drugs will be tested in patients. In a group of 100 to 500 patients, some of them will receive the new drug and another will receive a placebo or another medicine. All the side effects are collected and the main focus is on how effective it is.
Phase III: Extension of Patient Group
The candidate drug is being tested on a large scale in a much larger group of patients in hospitals world-wide. How it is in practice, there are potential interactions with other media. Adverse reactions are further complemented.
Official registration
Scientists from the European and American drug service evaluate the data from all the phases examined. Only when they evaluate the product as safe and effective can the drug be officially registered and the patients use it.
Genetic mutations central
We have increasingly learned the human genome and the role of genetic mutations in the process of disease and healing. This offers opportunities for using resources that have already been registered more widely for other disorders or other types of cancer. Now, the entire multiannual development process must be completed, but we hope it will soon be faster. Nowadays, innovative programs such as the DRUP study of the Center for Personalized Cancer Therapy work. It examines whether end-cancer patients benefit from a targeted agent for another type of cancer.
Real-world data
New computer systems may include larger amounts of existing data at the onset of drug development (real-world data). For example, in a new treatment for breast cancer, data can be analyzed for all existing anticancer agents. This helps researchers predict with increasing certainty how a drug will work, even before clinical research. Only data from participants in clinical trials are now included in the evaluation of a new drug. The procedure may be faster and more effective if data from all other patients are measured worldwide.
Medical precision
The DNA profile provides important information about inherited characteristics. Full reading of this profile can also help to predict whether or not to take medication in an individual patient. This makes the use of the drug more effective and the patient gets the treatment that suits him best.
Text: Karen Jochems
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