SamaGong. In clinical trials ideally all the pa
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Posted On: 04/11/2025 3:22:45 PM
SamaGong.
In clinical trials ideally all the participants have to be vetted so one is comparing apples to apples. These characteristics include:
Health Status: Trials may require healthy volunteers or patients with specific conditions.
Age and Gender: Some studies focus on particular age groups or genders.
Medical History: Participants may need to have or avoid certain medical conditions or treatments.
Lifestyle Factors: Factors like smoking, alcohol consumption, or exercise habits might be considered.
Diversity: Increasingly, trials aim to include diverse racial, ethnic, and socioeconomic groups to ensure results are broadly applicable.
In the particular case of our mTNBC patients several of these apply (gender is a given) but others don't. Additionally, we do't have data of a comparable group time-of-event (we know only the Leronlimab-treated) response.
However, if one knows the enrollment conditions for the Trodelvy trial and their Kaplan-Meier data it would not be difficult at all to compare with our data as the time passes and make a pretty good estimate of the probable P. The only difficulty here is that the Trodelvy arm would have more patients than our arm reducing the statistical significance of the analysis.
However, even in these conditions, one can get a darn good idea of the effectiveness of the treatment.
In clinical trials ideally all the participants have to be vetted so one is comparing apples to apples. These characteristics include:
Health Status: Trials may require healthy volunteers or patients with specific conditions.
Age and Gender: Some studies focus on particular age groups or genders.
Medical History: Participants may need to have or avoid certain medical conditions or treatments.
Lifestyle Factors: Factors like smoking, alcohol consumption, or exercise habits might be considered.
Diversity: Increasingly, trials aim to include diverse racial, ethnic, and socioeconomic groups to ensure results are broadly applicable.
In the particular case of our mTNBC patients several of these apply (gender is a given) but others don't. Additionally, we do't have data of a comparable group time-of-event (we know only the Leronlimab-treated) response.
However, if one knows the enrollment conditions for the Trodelvy trial and their Kaplan-Meier data it would not be difficult at all to compare with our data as the time passes and make a pretty good estimate of the probable P. The only difficulty here is that the Trodelvy arm would have more patients than our arm reducing the statistical significance of the analysis.
However, even in these conditions, one can get a darn good idea of the effectiveness of the treatment.
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