Clinical Research & Clinical Trials

Clinical Research

Clinical research is a branch of medical research that involves the study of human subjects to evaluate the safety and effectiveness of new drugs, treatments, medical devices, or diagnostic procedures. It plays a crucial role in advancing medical knowledge, improving patient care, and developing new therapies.

Clinical research typically follows a well-defined scientific process and involves several stages:

Study Design: Researchers develop a detailed plan outlining the objectives, methodology, and criteria for participant selection. This plan is known as a protocol.

Ethical Approval: The research protocol undergoes review by an ethics committee or institutional review board (IRB) to ensure the rights, safety, and well-being of the participants are protected.

Participant Recruitment: Researchers recruit eligible individuals who meet the predefined criteria for participation in the study. Informed consent is obtained from each participant, clearly explaining the study purpose, procedures, potential risks, and benefits.

Intervention or Observation: Participants are assigned to different groups, such as the experimental group receiving the new treatment or intervention, and the control group receiving standard care or a placebo. The study's progress is closely monitored, and data is collected according to the protocol.

BIMO - Bioresearch Monitoring Program - The Food and Drug Administration (FDA) has a framework in place called the Bioresearch Monitoring Program (BIMO) to guarantee the safety of research participants and the reliability of clinical research data. The BIMO guidance manual provides guidelines for clinical researchers to adhere to in order to assure compliance.

CRF - Case Report Form - An electronic or paper questionnaire known as a case report form is used in clinical trial research to gather information from participants.

EDC - Electronic Data Capture - Clinical research professionals collect data using an electronic data capture technique on a digital platform. Data management is aided by an EDC platform, which enables researchers to gather, process, evaluates, and analyses data remotely. This helps speed up the time it takes for sponsors to bring devices to market.

GCP - Good Clinical Practice - All clinical research is built on the principles of good clinical practice (GCP). Everyone who participates in clinical studies will be given the protection they need thanks to this set of guiding principles.