Glossary entry

English term or phrase:

be related ...similar clinical importance

English answer:

related to each other and have similar clinical importance

Added to glossary by Veronica Prpic Uhing
Sep 25, 2005 00:53
18 yrs ago
English term

be related ...similar clinical importance

English Medical Medical: Pharmaceuticals
Context: Composite Clinical Benefit End Points. A composite end point may be appropriate when the drug¡¯s benefit is multifaceted. The end-point components should be related and generally of similar clinical importance. Pamidronate was the first bisphosphonate drug approved to decrease morbidity of skeletal metastases£» it was initially approved for myeloma and, subsequently, for breast cancer. The applicant developed the end-point SREs, which included one or more of the following£º pathologic fractures, radiation therapy for local pain, surgery to stabilize near-fractures, or spinal cord compression. In the applicant¡¯s myeloma and breast cancer trials, treatment with pamidronate resulted in both a decrease in the proportion of patients with at least one SRE and an increase in time to first SRE. Recently, a second bisphosphonate, zoledronate, was approved on the basis of similar end points. Composite end points can also be constructed from symptoms. Clinical benefit response¡ªa composite end point of pain, performance status, and weight gain¡ªwas supportive of regular approval of gemcitabine for treatment of pancreatic cancer, although a small, statistically significant survival improvement was the primary approval basis.

Doest the sentence mean the ¡°The end points¡± are be related to one another, or they are related to clinical importance? I saw a Chinese version of the sentence (¡°The end-point components should be related and generally of similar clinical importance¡±) in a book, which if translated again into English literally means that the composition of the end-points should be related to clinical importance? Is the Chinese version makes sense?

Responses

+6
2 hrs
Selected

related and similar

Clinical end-point is a characteristic or variable that reflects how a patient feels, functions or survives.

The end-points of a clinical study are therefore, always related to particular type of clinical importance.


What the sentence said that the end-points should be related to each other AND have similar clinical importance.
Peer comment(s):

agree Aleron
52 mins
Thank you!
agree Refugio : related to each other
3 hrs
Thank you!
agree Jeannie Graham
9 hrs
Thank you!
agree Alfa Trans (X)
13 hrs
Thank you!
agree Jörgen Slet
1 day 19 hrs
Thank you!
agree Saleh Chowdhury, Ph.D.
4 days
Thank you!
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4 KudoZ points awarded for this answer. Comment: "Thank you both for kind help!"
+1
4 hrs

The end-point components should be related to **each other** and...

The original article appears in the Journal of Clinical Oncology. The author makes a general statement that the end-points should be related (to each other) and illustrates this by listing a series of skeletal-related-events (SRE) which are related in that they all involve complications of cancer affecting the spine.
He also states that the endpoints should have similar clinical "importance" and by this I assume he means that the different end-points would result in interventions or decision-tree node branches of similar significance.
The translation from Chinese does not mean the same thing. The reference to similarity of complications is gone. I would interprete the resulting sentence to mean that the composite end-points should be selected according to the relevance of the clinical events, which is self-evident. Why would one pick clinical outcomes which were not clinically important?
Peer comment(s):

agree Jörgen Slet
1 day 17 hrs
Thank you.
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