Forum

Notifications
Clear all

Clinical Trial Phase 2 Observations

4 Posts
4 Users
0 Reactions
756 Views
(@yroberts)
Posts: 30
Trusted Member
Topic starter
 

The researchers will choose a few patients to test the impact of the new medications. Researchers learn about the effects of new medications by studying the reactions of these few people in four phases. In phase 2, the individuals are observed for an extended length of time by the researchers (several months). Please explain why. During this period, what major observations were made?

 
Posted : 25/09/2021 6:53 pm
(@jaf22)
Posts: 83
Trusted Member
 

Usually a phase 2 trial will have a more statistical sample size with the medication with the most favorable outcome from phase 1. This extended time is used to start to derive the efficacy of the drug as well as if there is a placebo effect rather than an effective medication. The observations are typically the outcomes of the medication over a course of time and to see what may happen in a longer term. Some drugs may work initially, but there isn't confidence on their effects over a longer time period that needs to be vetted out during these trials. The other observation to make is whether or not there is a placebo effect and the drug isn't actually working. If there isn't a statistic that says the drug can work most of the time, then its hard to build a story to move forward with this new medication vs just continuing with the one that may be already on the market. 

 
Posted : 18/10/2021 9:29 pm
(@archishak)
Posts: 71
Trusted Member
 

Phase 2 of a clinical trial is crucial for testing new medications. It is during this phase that researchers observe the effect of the drugs being tested on a small group of people for an extended period of time. This phase is done to assess the safety and tolerability of the drug as well as to optimize the dose of the medication at hand. Major observations that can be seen during phase 2 include but are not limited to, efficacy, where researchers would study the effectiveness of the drug and understand if/how the drug reduced the symptoms. Another observation can include understanding the relationship between the dose of the medication and the response of the participants to that dose. This would help establish the dosage needed for the medication to work at its fullest capacity. Lastly, the long-term effects can also be studied during this phase. 

 
Posted : 27/10/2023 7:16 pm
(@jo277)
Posts: 69
Trusted Member
 

From my internship at a CRO, I was able to observe the workings of phase 1 and 2 clinical trials that were happening. For the study in its second phase, I was able to witness a developed drug undergo its human participant testing in a very precise controlled manner. The specific drug in question required the patient to have a large amount of inpatient days in order for the investigator and associated nurses to be able monitor the patient's effects, whether it would be through its efficacy and effectiveness as a proposed treatment, any adverse/unknown side effects, and the human interaction(s) that might be impacted by the drug. There is an extremely slim chance that any hazard could occur because these drugs have been developed for quite a long time. Needless to say though, the precautions and inclusion/exclusion criteria are made to ensure that the risk to patient health is minimized. 

 
Posted : 27/10/2023 11:27 pm
Share: