It’s always fascinating to read the news about a groundbreaking discovery in the medical field. But we often do not see the same medications on the market the next day of news publication. That’s because the regulatory authorities do not provide permission to use such medicines in public without identifying the safety and effectiveness of the same on humans.
That’s where the clinical trials come into play. The clinical drug trials are meant for testing the experimental medicines and treatment options to understand the safety, dosage and effectiveness of the targeted ailment. If you are curious about the exact process of new medicine being made available to the public through clinical trials, you are at the right place.
Process of Conducting Clinical Trials
#1 – Trial Design
The entire trial is governed by the regulatory authorities, which play an imperative role in the entire process. The authorities recommend the researchers design a complete trial methodology. This methodology or blueprint includes the aim of the trial, number of participants, type of medicines, fallback procedure, patient rights, treatment options, and many other things. This design is nothing but the raw plan of the trials, which has to be approved by the authorities and has to be adhered to all the time.
#2 – Participant Recruitment
Once the blueprint design is finalized and approved by the regulatory authorities, the researchers work on recruiting the participants. Based on the regulations and rules mentioned in the blueprint, the researchers start the recruitment process. They can recruit the participants manually, through the referral of the doctors, through advertisements or other sources. With the proper consideration of the informed consent and other formalities, the recruitment is completed and the actual trial begins.
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#3 – Beginning of the Clinical Trials
Once the recruitment is complete, the researchers start the actual trial. The entire trial is summed up in three phases. Each phase has a different aim and the number of participants varies between the phases. The first phase is aimed at identifying the safety of the medicine with the small group. The second phase is aimed at identifying the effectiveness of the medicine for the specific disease. The third phase is aimed at identifying the right amount of dose for the administration. Once everything is done, the data is collected and the final report is submitted to the regulatory authorities.
#4 – Regulatory Approval
As the trial is concluded and data is sent to the authorities, the ball now goes into the authority’s court. The authorities will check the data and arrive at the conclusion. If everything is perfect, then the authorities provide the final approval to the clinical trial and the medicine or treatment option can be made available to the public.
Final Words
The researchers have to do a lot of work in developing and testing the medicines and treatment options. In this post, we tried our best to explain how clinical trials operate and new medicines are made available to the public.
