spacer
home > white papers > Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials - Perceptive Informatics
WHITE PAPERS
logo_Perceptive2.jpg

Perceptive Informatics

phone +1.781.487.9900
web http://www.perceptive.com
email 195 West Street, Waltham, MA 02451, USA

Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials

Standardized assessment criteria are becoming increasingly important in obtaining valid outcomes in oncology clinical trials. While standardized criteria encourage a more uniform approach to assessing clinical trial data, they are often subject to the interpretation of the user. These differences in interpretation, while seemingly minor, can have a major impact on assessments. The most commonly used standardized criteria for lymphoma have been no exception. Differences such as minimum new lesion size, lymph node normalization size requirements, inclusion of extranodal lesions and assessment of organomegaly can have a profound effect on overall response. Additionally, heightened scrutiny of the assessment criteria used in a given protocol can lead to questions about a drug’s efficacy if not applied correctly according to regulators’ interpretation.
Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

Staffordshire company Woolcool wins 2018 Queen’s Award for Innovation

The world is crying out for genuinely sustainable alternatives to manmade plastic packaging, so the winning of a Queen’s Award for Enterprise in Innovation by Staffordshire company Woolcool demonstrates the very real credibility of using a natural, renewable packaging resource – sheeps wool. First conceived by founder and CEO Angela Morris in 2001, Woolcool is a superior insulated packaging solution for the transportation of temperature-sensitive goods for the food and pharmaceutical sectors.
More info >>


White Papers

Challenges of Analytical Method Transfer in the Pharmaceutical Industry

RSSL

The development and validation of suitable analytical methods is a critical part of the overall drug-development life-cycle. For the majority of products, particularly those that are clinically successful, the transfer of the analytical method between laboratories will be required. This process is designed to verify that a given laboratory is capable of performing a test method for its intended purpose. This can be performed either internally (at the same company), or, with the on-going increasing trend in outsourcing, to an external Contract Research or Development organisation (CRO or CDO).
More info >>


Industry Events

SMI Immuno-Oncology Conference

25-27 September 2018, Copthorne Tara Hotel, London, UK

Immuno-Oncology is a fast-paced field with massive potential to deliver successful and durable cancer therapies, and SMi's Immuno-Oncology Conference will focus on a few key areas of the field with a representation of the whole industry under each area. These areas will be drawn together to look towards the future of Immuno-oncology and how the field can progress.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement