The role of data monitoring in clinical research
The final stage of the ONCOCHECK Project is approaching –time flies! We believe it is important to talk about the importance of monitoring tasks in clinical trials and observational studies.
There are different types of clinical research approaches and the question being investigated will determine which study design is more appropriate, depending if it is a clinical trial used to test safety or efficacy of a new drug or an observational study used to collect epidemiological data or prove biomarker efficacy, etc.
In this case, the ONCOCHECK Project includes 6 observational studies. Even though there are many differences, mainly of ethical nature between clinical trials and observational studies, there are several common and fundamental questions that every clinical research study should follow.
On the one hand, clinical studies must be carried out in accordance with ethical principles, which have their origin in the Declaration of Helsinki, and are specified on each country legislation. They must also follow ICH guidelines: in 1995, the International Conference on Harmonization, constituted by the European Union, Japan and the United States, met to agree on a common guideline of good clinical practice standards that all types of clinical research must comply with.
The fundamental principles of the ICH guidelines are to ensure the well-being of the participants in the study and to guarantee the quality of the data in the research. Due to this necessity, the concept of monitoring surges. Monitoring can be defined as the act of overseeing the progress of a clinical study with the following objectives:
- Ensure the safety, well-being and ethical rights of the participants.
- Verify that the data in clinical trials is reliable, accurate and complete.
- Guarantee that the monitoring process is conducted, recorded and reported in accordance with the protocol in place, Standard Operations Procedures (SOPs), Good Clinical practice (GCP) and the applicable regulatory requirements.
The person in charge of carrying out the monitoring tasks is the Clinical Research Associate (CRA), a professional with the necessary clinical competence who is responsible for the direct follow-up of the clinical trial. Furthermore, they also work as a link between the promotor of the study and the investigating hospital team. The CRA must also review the Case Report Form (CRF) and the Inform Consent Form (ICF), which play a fundamental role in the development of a clinical study. The CRF is a printed, optical or electronic document where all the information for the study is collected. Likewise, the ICF is the principal mechanism for ensuring the rights of the participants. Signing this document, a person confirms their willingness to participate in the clinical research after being informed of all the parts of the study that are relevant to the individual and risks involved, if any.
Working on six different studies -with over 5000 samples collected!, monitoring has been a real challenge and a colossal task yet clearly relevant as it has allowed us to detect promptly inclusion criteria mistakes, ensure longitudinal samples follow ups and to guarantee the veracity of the clinical parameters minimizing mistakes. Undoubtedly, the increasing complexity of clinical trial systems requires better patient safety, data quality and operational efficiency. Centralized monitoring facilitates these tasks to improve the ability for managing data quality and subject safety. Therefore, Clinical Research Associates play a key role now and in the future of clinical trials.
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