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Clinical Research: A Review of Study Designs, Hypotheses, Errors, Sampling Types, Ethics, and Informed Consent
Addanki Purna Singh1, Sabitha Vadakedath2, Venkataramana Kandi3
1Physiology, Department of Biomedical Sciences, Saint James School of Medicine, The Quarter, AIA.
Abstract:
Recently, we have been noticing an increase in the emergence and re-emergence of microbial infectious diseases. In the previous 100 years, there were several incidences of pandemics caused by different microbial species like the influenza virus, human immunodeficiency virus (HIV), dengue virus, severe acute respiratory syndrome Coronavirus (SARS-CoV), middle east respiratory syndrome coronavirus (MERS-CoV), and SARS-CoV-2 that were responsible for severe morbidity and mortality among humans. Moreover, non-communicable diseases, including malignancies, diabetes, heart, liver, kidney, and lung diseases, have been on the rise. The medical fraternity, people, and governments all need to improve their preparedness to effectively tackle health emergencies. Clinical research, therefore, assumes increased significance in the current world and may potentially be applied to manage human health-related problems. In the current review, we describe the critical aspects of clinical research that include research designs, types of study hypotheses, errors, types of sampling, ethical concerns, and informed consent.
Insights
Clinical research is vital for tackling rising infectious and non-communicable diseases. This review covers essential clinical research aspects, including designs, hypotheses, errors, sampling, ethics, and informed consent.
Area of Science:
- Medical Research
- Public Health
Background:
- Increasing emergence/re-emergence of microbial infectious diseases (e.g., influenza, HIV, SARS-CoV-2).
- Rising incidence of non-communicable diseases (e.g., malignancies, diabetes, cardiovascular, kidney, liver, lung diseases).
- Growing need for improved preparedness in healthcare systems globally.
Purpose of the Study:
- To highlight the critical importance of clinical research in managing global health challenges.
- To provide a comprehensive overview of fundamental clinical research principles.
Main Methods:
- Review of key clinical research components.
- Discussion of research designs and study hypotheses.
- Examination of sampling techniques, potential errors, ethical considerations, and informed consent.
Main Results:
- Clinical research is essential for addressing both infectious and non-communicable disease burdens.
- Understanding research designs, hypotheses, sampling, and ethics is crucial for effective study implementation.
- Ethical considerations and informed consent are paramount in all clinical research.
Conclusions:
- Enhanced clinical research capabilities are necessary to combat current and future health emergencies.
- A solid grasp of clinical research methodologies ensures the generation of reliable health data.
- Ethical conduct in clinical research is fundamental to protecting participant rights and ensuring public trust.
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