Research and development
1. In which countries are clinical trials conducted? Clinical trials can be conducted in all countries of the world – USA, South America, whole European Union, Asia, Australia...
2. When seeing the term clinical trial many people might think – am I going to be the first one to take the investigational drug? No, you are not. Hundreds of patients worldwide have already used the drug before you. All detailed information can be found in Informed Consent and you can also ask the investigator.
3. What happens if I sign the Informed Consent Form, enter the clinical trial and then for any reason change my mind? You can withdraw your consent anytime, without providing any reason. You should just notify the investigator about your decision. At that moment, the clinical trial is over for you and the investigator will prescribe you the standard treatment. You should think about your decision carefully because after the consent withdrawal you can not return back into clinical trial.
4. Why do we need drug research and development? Currently, it is possible to cure approximately one quarter of all diseases, whilst the number of new diseases is constantly rising. Pharmaceutical companies remind us that drug research and development is a very long, expensive and risky process and because of the high requirements on patients’ safety, it takes in average 12 years. The price of new drug development has also increased multiple times – today it costs ca. 1 billion euro, which is about one fifth of annual costs of whole healthcare services in Slovakia. To discover a new drug, ten thousands of chemical compounds need to be studied and even of those successful ones, only one of three covers its costs. The importance of finding new drugs is unquestionable. Thanks to original drugs, many diseases became curable or better tolerated (e.g. drugs can prolong life of people with cancer, patients with mental disorders don’t have to spend so much time in medical institutions, HIV positive people can live for decades without significant problems, the mortality caused by cardiovascular diseases has decreased).
5. How is the drug safety and efficacy tested? Manufacturers test and evaluate safety of newly discovered drugs in longtime pre-clinical and clinical trials. A trial of one new drug takes 3 to 10 years and involves thousands of healthy volunteers and patients. Research oriented manufacturers conduct these clinical trials also in Slovakia –they annually invest several millions eur in clinical trials in Slovakia, in which hundreds of physicians and thousands of patients participate. To be able to perform a trial in Slovakia it is necessary to receive an approval from State institute for drug control (ŠÚKL) and the requirements for a trial conduct are specified by law (no. 362/2011, Act on medicines and medical devices). But the research continues also after receiving the marketing authorisation. Drug manufacturers monitor the safety and efficacy of the drug in so-called post-marketing trials. It might happen that a new indication for a certain drug will be discovered, which might cause a milestone in research. For example aspirin, which was originally ment to treat pain or fever, is nowadays used for prevention of coronary diseases.
Clinical trials of drugs or clinical studies include all research in humans, which purpose is to discover and confirm clinical, pharmacological and/or other pharmacodynamical effects of investigational product, and/or determining all of the adverse events of the investigational product with the objective of evaluating it’s safety and/or efficacy. Clinical trial evaluates also the bioavailability and bioequivalency of an investigational product.
Clinical trial is performed according to the protocol, which contains the aim and design of the trial; inclusion and exclusion criteria, methods of monitoring and conducting the trial; requirements for storage of investigational product or investigational drug and for handling with it, methods of statistical evaluation and publishing of results; approval of changes in the protocol and person responsible for conduct of the trial. Such clinical research in volunteers is possible only with investigational product that reached satisfactory results in pre-clinical tests and their safety has been confirmed. Clinical trials can be iniciated only after receiving approval from respective regulatory authority and etical comittee. Clinical trials underlie strict regulations and the whole process is monitored.
Clinical trials are carried out in four phases:
References and links to useful information: