Development of suitable, safe, quality and efficient (drug) product is a long, complicated and expensive period in which preclinical and clinical research is crucible. Preclinical development is a stage before clinical trials with aim to investigate and confirm safety dose, toxicity, pharmacodynamics and pharmacokinetics, studies are normally performed in laboratory animals, cell cultures and synthetic or isolated organs or tissues. After the approval of »Investigational New Drug Process« application clinical studies are allowed to start- they are carried out on healthy volunteers or real patients (oncological drugs) and consist of 3 different levels (phase I, phase II, phase III). Main purpose of clinical trials is evaluation of absorption, distribution, metabolism and elimination of active pharmaceutical ingredient and confirmation of previously proved data in preclinical research. Every step of development is based on good clinical practice and is executed by professional, appropriately trained and educated staff (sponsor, monitor, main researcher and team of researchers). Phase IV is post-marketing control of approved products and lasts until the last product is on stock.
Statistics of prematurely completed clinical studies which were suspended, terminated or withdrawn out of different reasons from 01.01.2019 until July/August 2020 were collected on website clinicaltrials.gov. It was concluded that the most frequent reason for clinical study fails in phase I, II and III is COVID-19 (21,67% in Phase I, 20,33% in Phase II, 18,05% in Phase III). Toxicity as reason is taken into account only when stated straightforward (unsuitable safety profile, side effects, …), but is the minority among reasons.
Data for drug recalls were collected on FDA website and it was established that the most common reason for product withdrawal are detection of nitrosamines (34,95%) in products with Ranitidine, Metformin and Sartans, and microbiological contamination (25,2%) in products for parenteral application.
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