Clinical Trials - Process

What happens during a clinical trial?

There are various stages in a Clinical Trial. They are as follows:

1. Drug Development and Approval process
2. Clinical trial Protocol
3. Patient Enrolment
4. Analysis of results
5. Publication of results

• Every Clinical Trial is unique in its own way and is designed in such a way so as to answer the specific reasons for which the trial is being done.
• A "protocol" or Trial plan maps out what study procedures will be done, by whom, and why.
• The clinical trial team consists of doctors and nurses as well as other health care professionals who monitors the participants health during the various stages of the trial once the patient has been found eligible to participate in a particular study.
• Patients are initially identifed by a process know as SCREENING where Investigators identify possible Participants by investigating if they meet the Clinical Trial Inclusion and Exclusion Criteria.
• Once a participant has been found suitable for the trial, the investigator explains to him about his role in the trial and also about the benefits and risks associated with the same and the participant is then asked to sign an informed consent form, giving his/her consent to participate in the trial.
• On signing the Consent form, the study procedure starts and the participants are enrolled. After the enrollment process the Participant goes through an initial set of tests/procedures and if still meeting the criteria for the study is provided with instructions and the Study Treatment and given review dates.

Advertisement

• Participants are monitored and carefully assessed during the trial as well as after it is completed.
• Clinical trials are usually done at hospitals and are conducted in phases (I, II & III).
• After a phase I or phase II trial is completed researchers analyze the data collected and make a crucial decision whether to: Move on to the next phase of the trial (Phase III) with the treatment, or to stop testing the drug / treatment because it is not safe or effective.
• If any harm has come to patients, (bad drug reactions for example) the trial may be stopped early.
• Trials can also be closed early if the new treatment is giving much worse results than the standard treatment, in such conditions patients on the new drug or treatment will be immediately switched to the standard treatment.

Advertisement

• After phase III trials are completed a complete analysis of all three phases are done and researchers decide if the results have any significant medical importance and publish their results in scientific or medical journals where experts review the report before it is published, to make sure that the analysis and conclusions are sound.
• Results for several trials of the same treatment may be analysed together and published. This is often called a 'meta-analysis'
• Once a new drug or intervention is proven safe and effective in a clinical trial, it may become the new standard of practice.