Paper Details 
Original Abstract of the Article :
Assessing safety is important to evaluating new medications. In many randomized clinical trials, assessment of safety relies on so-called on-treatment analysis, where data on adverse events are collected only while the participant is taking study medication and perhaps for a few (7, 14, or 30) days ...See full text at original site
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引用元:
https://doi.org/10.1177/1740774518812774

データ提供:米国国立医学図書館(NLM)

Safety Analysis: Navigating the Sands of Clinical Trials

The process of evaluating the safety of new medications can be challenging, like navigating a vast and shifting desert landscape. This research, like a seasoned guide, warns against the pitfalls of on-treatment safety analyses.

The Importance of Intent-to-Treat Analysis

The authors argue for the use of intent-to-treat (ITT) analyses, which include data from all participants regardless of whether they received the study medication or not. This approach, like a carefully planned camel caravan route, ensures a more comprehensive and accurate assessment of safety. On-treatment analyses, by contrast, can provide a misleading picture of a drug's safety profile, potentially overlooking important information.

Ensuring the Safety of New Medications

This research underscores the importance of robust safety assessments in clinical trials. It's like making sure your camel caravan has a reliable supply of water and a clear map before venturing into the desert. This research highlights the need for rigorous methods, such as ITT analyses, to ensure the safety and efficacy of new medications. This research reminds us that we must be vigilant in our pursuit of new and innovative therapies, ensuring that they are both effective and safe for those who need them.

Dr. Camel's Conclusion

This research emphasizes the importance of conducting thorough safety analyses in clinical trials. The authors advocate for the use of ITT analyses, which provide a more accurate and reliable assessment of a drug's safety profile. Like a skilled camel herder who carefully inspects their animals before setting out on a journey, we must ensure the safety and efficacy of new medications before they are widely used.
Date :
  1. Date Completed 2020-03-17
  2. Date Revised 2020-03-17
Further Info :

Pubmed ID

30445833

DOI: Digital Object Identifier

10.1177/1740774518812774

Related Literature

SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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