Blog - 15

✨ 𝐁𝐚𝐬𝐢𝐜𝐬 𝐨𝐟 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬 ✨

If you are seeing this post of BIIHR’s, chances are you already know what’s a clinical trial. We bring this article to you to highlight the basics of this topic. Clinical trials are essential research studies conducted on human participants to evaluate new ways of treatment. These trials are the backbone of medical advancement, ensuring that new treatments are safe and effective before they are made available to the public.

📝𝗣𝗵𝗮𝘀𝗲𝘀 𝗼𝗳 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀

Clinical trials are typically conducted in four distinct phases, each designed to answer specific questions about the treatment under investigation.

📄𝙋𝙝𝙖𝙨𝙚 𝙄: 𝙎𝙖𝙛𝙚𝙩𝙮 𝘼𝙨𝙨𝙚𝙨𝙨𝙢𝙚𝙣𝙩

Phase I trials are the first stage of testing in humans. These t involve a small group of healthy participants (20 to 80 individuals). The primary goal is to assess the safety of the new treatment, including its side effects and how the human body processes the drug. This phase helps determine the appropriate dosage and potential risks.

📋𝙋𝙝𝙖𝙨𝙚 𝙄𝙄: 𝙀𝙛𝙛𝙞𝙘𝙖𝙘𝙮 𝙀𝙫𝙖𝙡𝙪𝙖𝙩𝙞𝙤𝙣

If a treatment is found to be safe in Phase I, it progresses to Phase II, where the focus is on testing its effectiveness. This phase involves a larger group of participants(100-300 persons) who have the condition that the treatment is designed for. Researchers continue to monitor safety while assessing whether the treatment works as intended. Phase II trials further refine its safety profile.

📑𝙋𝙝𝙖𝙨𝙚 𝙄𝙄𝙄: 𝘾𝙤𝙢𝙥𝙖𝙧𝙞𝙨𝙤𝙣 𝙬𝙞𝙩𝙝 𝙎𝙩𝙖𝙣𝙙𝙖𝙧𝙙 𝙏𝙧𝙚𝙖𝙩𝙢𝙚𝙣𝙩

Phase III trials are conducted on an even larger scale, often involving hundreds or thousands of participants. The goal is to compare the new treatment against the current standard or a placebo. These trials are usually randomized. This phase provides data on the treatment's effectiveness, monitors side effects, and helps determine if the new treatment offers significant advantages over existing options. Successful completion of Phase III is often the final step before the treatment is ‘launched’.

🔎𝙋𝙝𝙖𝙨𝙚 𝙄𝙑: 𝙋𝙤𝙨𝙩-𝙈𝙖𝙧𝙠𝙚𝙩 𝙎𝙪𝙧𝙫𝙚𝙞𝙡𝙡𝙖𝙣𝙘𝙚

Phase IV trials take place after a treatment has been approved by regulatory bodies and is available to the public. These studies monitor the long-term safety and effectiveness of the treatment. Data on any rare or long-term side effects are collected and used to evaluate the treatment's performance in real settng.

🔸𝗘𝘁𝗵𝗶𝗰𝗮𝗹 𝗖𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀🔸

All clinical trials abide by a protocol highlighting ethical considerations. For more details about ethical considerations, please visit: https://www.biihr-bd.org/blogs/blog-9

📌𝗖𝗼𝗻𝗰𝗹𝘂𝘀𝗶𝗼𝗻

Clinical trials are a critical component of health research, playing a key role in bringing new treatments to healthcare. By progressing through the four phases of clinical trials, new treatments are rigorously tested to ensure they are safe, effective, and useful to the diseased community. The participation of volunteers in clinical trials not only contributes to their own health but also advances medical knowledge, potentially benefiting countless others in the future once the treatment went through the rigmarole of clinical trials and has made to the market!

Written by-

𝐍𝐚𝐳𝐦𝐨𝐨𝐧 𝐍𝐚𝐡𝐚𝐫

Assistant Content Lead,BIIHR

Department of Pharmacy

Independent University, Bangladesh