According to Good Clinical Practice , clinical trial term refers to any investigation in human subjects intended to:
- discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s),
- and/or to identify any adverse reactions to an investigational product(s),
- and/or to study Absorption, Distribution, Metabolism, and Excretion (ADME) of an investigational product(s) with the object of ascertaining its safety and/or efficacy.
There are many stakeholders involved in clinical trial. The first, most obvious and important group are their subjects (patients or healthy volunteers), who are subjects of study procedures and receive investigational medicinal products. Clinical trials also involve sponsor, being an individual, company, institution or organization which takes responsibility for:
- study initiation,
- study management,
- and setting up the financing of the clinical trial.
The sponsor is obliged to fulfill numerous duties providing safety of clinical trial participants and ensuring credibility of trial results.
The third party of clinical trials stakeholders is the investigator. The investigator is a person responsible for the conduct of a clinical trial at a clinical trial site. The principal investigator is an investigator who is the responsible leader of a team of investigators who conduct a clinical trial at a clinical trial site. It is the duty of sponsor and the investigators to ensure that the clinical trial is conducted in accordance with the protocol and the principles of Good Clinical Practice (GCP). They are also responsible for the participants safety and guarantee their informed consent to participate in the trial.
At the stage a planning of clinical trial, it is necessary to clearly define study procedures, the endpoints of the study, and thus the required number of participants. The above factors affect the duration of the study, its costs and the credibility of results. In addition, when planning and conducting a clinical trial, one should also take into account numerous EMA guidelines, as well as generally accepted ICH guidelines, including the principles of Good Clinical Practice .
The selection of appropriate clinical sites to conduct the study is crucial in terms of patient recruitment and the quality of the obtained data. It is worth remembering that clinical sites may be the subject of inspections of relevant authorities and, if serious deviations are found, the authorities may question the results of the entire study.
All clinical trials, which will begin after January 31, 2023, should be conducted in accordance with Regulation 536/2014 of April 16, 2014 . In accordance with Regulation 536/2014, an application for clinical trial along with documentation should be submitted via The Clinical Trials Information System (CTIS) managed by The European Medicines Agency (EMA) . During submission of the clinical trial application, in case of documents for publication, it should be considered whether such documents contain commercially confidential information. In such case it is important to request for deferral in order to delay their publication .
An important factor influencing the quality of a clinical trial is its monitoring. It allows sponsor to ensure participants safety as well as the reliability of trial data. The sponsor is also obliged to conduct pharmacovigilance of the investigational medicinal product. The above-mentioned activities require the sponsor to have a structured quality management system.
An end of the clinical trial means the last visit of the last subject, or a later point in time as defined in the protocol. After the study is completed and the database is closed, obtained data is analyzed in accordance with the applicable guidelines . Based on the results of statistical analyzes, a clinical trial report  is prepared, which includes a description of the obtained results and conclusions from the study . The results of a clinical trial should be reported to the CTIS . When reporting results of clinical trials, protection of personal data and commercially confidential information should be taken into consideration. EMA has taken steps in order to give clear guidance how to approach those issues . A draft guideline is available since 7 April 2022 and defines among many, which data requires anonymization or can be published with the delay in CTIS.
Health-Med has extensive experience in conducting clinical trials, both as a sponsor of the study as well as the Manufacturer and Importer of the IMP. Health-Med’s regulatory experts provide assistance or may represent Client in obtaining permissions required to conduct clinical trial in EU. Health-Med cooperates with numerous clinics that may act as clinical trial site and run studies in certain indications. We also provide experts to monitor clinical trial to ensure its quality. What is more Health-Med can certify and release IMP, manage clinical study supply chain and organize its transport and storage in controlled conditions.
While applicable guidelines are constantly improved due to changing environment, also sponsors’ procedures and quality management systems (QMS) require frequent reviews and actualizations. It is worth considering cooperation with the team of experts who constantly monitor legal environment and guarantee conducting a study in line with up to date guidelines.
Health-Med is experienced in being a sponsor of clinical trials and has many years of wide practice, in clinical trials monitoring. What is more, Health-Med is certified according to Good Manufacturing Practice (GMP) as manufacturer responsible for batch certification of the products and importer. Our GMP certifications cover both: final medicinal products and IMPs. At Health-Med, our experience in clinical trials is complemented by also great practice in registration of medicinal products. Thus, the cooperation with Health-Med guarantees a holistic approach to the project. At Health-Med we can pride ourselves in having a multidisciplinary team of experts specialized in various fields what allows us to provide services related to the entire development of a medicinal product.
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