The importance of clinical trials for overall well-being

In order to determine whether a medicinal product is effective in treating a disease, what its adverse effects are, and how and at what doses it should be administered, a complex clinical trial for the study of its active substance on subjects in strictly controlled conditions should be performed. The emphasis is placed on the efficacy, safety and posology of an investigational product, i.e. its active substance. This applies to each product intended for marketing. Only after the clinical trial and processing of all the data has been performed that a decision is made as to whether a product will be authorised for use and treatment of a particular disease.

Clinical trials are the basis for the development of new therapeutic options for the treatment of patients, and they are useful for the society, medicine and, above all, patients, to whom today’s new therapeutic options through the use of new drugs provide an ever-increasing standard of care.

In certain cases, such as placing a generic drug on the market, bioequivalence studies may be required to demonstrate that the investigated drug produces the same amount of an active substance in the body as the reference medicine.

The first part of testing an active substance of a particular medicinal product is the preclinical phase, which is not performed on subjects but on animals and cell cultures in a laboratory. Only after favourable laboratory findings have been obtained can the phase on human subjects begin.

The clinical phase of product testing is performed in four phases:

Phase I – clinical trial conducted on a small number of subjects, is conducted on healthy volunteers to test the tolerability and toxicity of the investigational active substance.

Phase II – clinical trial conducted on a larger number of subjects, is conducted on sick volunteers to test the efficacy and determine the dosage of the drug-to-be.

Phase III – clinical trial conducted on a large number of subjects (over 1000), is conducted on sick volunteers to test the efficacy and safety of the investigational active substance. This phase is also the main phase of a clinical trial because the statistical processing of the data obtained during this trial phase is what decides whether a particular investigational active substance becomes a drug.

Phase IV – clinical trial conducted when the drug has already become commercially available. At this stage of the trial, mostly the side effects of the drug are monitored. A post-authorisation safety study (PASS) can be either interventional or non-interventional. Marti Farm also offers the non-interventional trial services, whereby PASS protocols, updated study protocols following major changes and clinical study reports are submitted to the regulatory authority depending on the trial location.

Clinical trials conducted in the EEA have to comply with the Directive 2001/20/EC. However, Regulation (EU) 536/2014 on clinical trials on medicinal products for human use will repeal the current Directive.

In the Republic of Croatia, the highest legal and ethical standards are implemented in the process of conducting clinical trials, and are aimed primarily at protecting study participants by assessing the risks for each subject at each step of the trial. Marti Farm has recognised its role in this, and as a contribution offers a full clinical trial management service, conducting of bioequivalence studies included. Our team includes project managers, auditors and clinical trial associates, which make up a complete team for providing a high-quality all-inclusive service package (from legal and regulatory to operative affairs). That is why Marti Farm was selected as one of the top 10 clinical trial consulting companies in Europe in 2019.

Given that clinical trials are an indispensable component of the advancements in modern medicine and the treatment of diseases for which no ideal solutions currently exist, it is extremely important to raise public awareness of subject participation in clinical trials and the need to conduct them.