Pharma, Pharmaceutics and Biotechnology Conference

Clinical trials and clinical research are the precursors to new treatments and other medical interventions.

Review of basic principles governing clinical trials, such as study design, ethical considerations, and data analysis, as well as the role of the patient in advancing medical science are also paramount in these investigations. Clinical research basically involves a clinical trial that is a scientifically controlled study of the safety and effectiveness of new treatments or interventions in human subjects.

Clinical trials fall under several classification types: Phase I, II, III, and IV among others. Phase I trials include the evaluation of the safety and dosage of a new drug in a small number of healthy volunteers, whereas Phase II trials on a larger number of patients are meant to assess the efficacy and side effects of the drug in the target condition. Phase III trials compare the new treatment with existing treatments and are considered necessary for the regulatory approvals. Phase IV trials or post-marketing studies, in fact, monitor the long-term effects and effectiveness of a drug once it is accepted by the public.

Study design is an important component of clinical trials because it determines the way participants are selected, what method of treatment is used, and how outcomes are measured. Randomized controlled trials are the gold standard of clinical research and, therefore, minimize bias that allows for very robust comparisons of between-treatment groups.

Therefore, during the session, the different study designs based on the organizational structures or approaches, such as observational studies and cohort studies, including their strengths and limitations, will be discussed. Ethical issues in clinical research involve the rights and welfare of the participants. This includes informed consent: disclosing the nature of the trial with the prospects and risks involved to the participants.

This will form the core ethical foundation of the clinical research. This session will touch on some of the ethical framework guiding clinical research and, more importantly, the role of the institutional review boards in ensuring welfare among participants.

The second important ingredient that follows is the data analysis of clinical trials. In this step, researchers must apply very rigorous statistical methods for analyzing the results so as to provide meaningful inferences about the efficacy and safety of the intervention.

This session will take up key concepts in biostatistics and the importance of significance in statistical analysis to interpret trial results. Involving patients in the design and conduct of trials is increasingly recognized as a core element in clinical research. In the end, this increases the relevance of the research and improves recruitment and retention rates.

This session will explore strategies for how patient engagement can foster research priorities that align with patient needs. This session will provide all participants with a clear overview of clinical trials and clinical research to understand how it advances medical science and improves the condition of their patients.

Also, the participant will be guided on study design, consideration of ethics, and the importance of patient involvement, among other issues, with the objective of equipping him or her with the basics necessary to contribute to clinical research endeavors.