Is there a license fee for use of the LCSS?
· The Lung Cancer Symptom
Scale (LCSS), a site-specific quality of life measure for patients
with lung cancer, is now in its second decade of development. Our
group, Quality of Life Research Associates, believes that each clinical
trial has had the benefit of the extensive testing of the measure,
and now, availability of 42 languages. In addition, we have tried
to provide recommendations, based on our experience to date for
this controversial but valuable endpoint, for avoiding problems
such as measurement bias in clinical trials. The FDA has found this
instrument acceptable in supporting new oncologic agents, and has
specifically encouraged its use. Our experience with this measure
on six continents is that once the LCSS is part of a clinical trial,
its ease for patients and staff is recognized, enhancing its use
in additional trials.
· For a clinical trial with a sponsor, there is a license
fee for use in each clinical trial of 50 or more patients.
This fee for use also includes permission to reproduce as many
copies of the copyrighted manual as needed and use of five translations
(see web page chart) for that specific trial. The fee variation
scale is simple: (1) for a smaller trial of less than 50 patients,
the fee is reduced; (2) if more translations are needed beyond the
five, there is an additional fee. In special circumstances for studies
without a sponsor or for special uses, one can apply for a partial
waiver of fees by letter. The license fee information is included
in the initial LCSS packet (see order form on website) and can be
obtained using overnight mail.