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Abstract

Clinical trials evaluate possible treatments on human participants, or subjects, in order to determine whether or not they should be licensed for broader usage in the general public. For a variety of reasons, clinical trials in India have historically been conducted worldwide. This study addresses clinical trials, namely those conducted in India. This are classified into different types based on their objectives, such as treatment trials, prevention trials, diagnostic trials, and others. Each type aims to address specific research questions related to the intervention's effectiveness. Clinical trials typically progress through several phases (Phase I to Phase IV) to evaluate different aspects like safety, dosage, efficacy, and potential side effects of the intervention. Each phase serves a specific purpose in the research process. Efficiency in clinical trials refers to conducting trials in a cost-effective and timely manner. Effectiveness assesses how well an intervention works in real-world conditions compared to its efficacy in controlled settings. Blinding involves concealing certain information from participants, researchers, or both, to minimize bias. Randomization ensures that participants are allocated randomly to different treatment groups, enhancing the validity and reliability of trial results.

Keywords

Clinical trials, Rigorous Protocol, Randomisation, Blinding, Adaptive design, Interim data Analysis.

Reference

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Sourabh Patil
Corresponding author

Department of Pharmacology, Ashokrao Mane Institute Of Pharmacy Ambap-416112, India

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Shreyash Koli
Co-author

Department of Pharmacology, Ashokrao Mane Institute Of Pharmacy Ambap-416112, India

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Suvarna Deshmukh
Co-author

Department of Pharmacology, Ashokrao Mane Institute Of Pharmacy Ambap-416112, India

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Tejas Kapase
Co-author

Department of Pharmacology, Ashokrao Mane Institute Of Pharmacy Ambap-416112, India

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Sachin Navale
Co-author

Department of Pharmacology, Ashokrao Mane Institute Of Pharmacy Ambap-416112, India

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Nilesh Chougule
Co-author

Department of Pharmacology, Ashokrao Mane Institute Of Pharmacy Ambap-416112, India

Sourabh Patil, Shreyash Koli, Suvarna Deshmukh, Tejas Kapase, Sachin Navale, Nilesh Chougule, Clinical trial design in drug : enhance safety and efficacy, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 1, 274-287. https://doi.org/10.5281/zenodo.10517914

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