Clinical Trial Resources

Clinical Trial Background

• A Patient's Experience With Several Clinical Trials by Ian Liston

• A Patient's Experience with IMC-A12 and MDV3100 by George Kosaly

• Clinical Trials - Should we Participate? A contemporary analysis of the clinical trial process by W. Aishman.

• Evaluating Solid Tumors, the RECIST 1.1 Guidelines (2009).

• Evaluating Toxicity. Adverse events in clinical trials are graded 1,2,3 and 4 (mild to fatal). See Common Terminology for Adverse Events 2009.

• Evaluating Performance Status - The ECOG Scale

• Evaluating Performance Status - The WHO scale.

• Evaluating Performance Status - The Karnofsky scale.

• How to Read a Paper (important for reading phase I, II, III trial results.)

• Insurance Coverage for Patients Participating in Clinical Trials. 26 states require health insurance companies to pay for "routine" care.

• Median Explained -- read Jay Gould's "The Median Isn't the Message."

• National Cancer Institute – Cancer Trials; Finding Clinical Trials; Understanding Clinical Trials and other Clinical Trial Resources.

• Israel Barken's "Why Join a Trial" essay: http://www.prostatepointers.org/barken/study.html

• Onconurse Factsheets (http://onconurse.com/factsheets/trials_resources.html)

• Understanding Prognosis and Cancer Statistics -- National Cancer Institute.

Compassionate Use of Investigational Drugs

• Compassionate Use for Access to Unapproved Drugs. This link will take you to an articlethat 1st appeared in the Fall 2004 issue of Cure Today. It describes the FDA's Early Access Program and single patient use.  You need to know the criteria, understand the law, do a lot of leg work and enroll your doctor in this quest.

• Another resource for compassionate use is located on the .American Cancer Society Compassionate Use webpage;

• The US National Cancer Institute also covers this topic - "Access to Investigation Drugs - Questions and Answers." 

• US FDA has, "Access to Unapproved Drugs." It is not an easy process. 

• An editorial written by Jerome Yates, M.D. entitled Food and Drug Administration, Partner in Drug Development contains many useful insights into the process.

Clinical Trials Consortiums

• Cancer and Leukemia Group B www.calgb.org

• National Comprehensive Cancer Network (NCCN) - also has links to member websites.  See the NCCN's Clinical Trials page.

• Southwest Oncology Group www.swog.org

Organizations That Help You Find a Trial or Provide Information on Clinical Trials

• Prostate Cancer Research Institute (PCRI for short) has a list of prostate cancer trials from the NCI's website.  They also have a page with additional information on trials.

• Us Too Clinical Trials Pages - access to many resources.

Clinical Trial Results Evaluation

RECIST - this stands for Response Evaluation Criteria in Solid Tumors. Version 1.1 has been published in Eur J Cancer, 2009 Jan 1, EA Eisenhauer, et al  and you can download the PDF of the paper from http://www.eortc.be/recist/documents/RECISTGuidelines.pdf. Revisions include the use of fewer lesions for assessment, evaluation of short-axis lymph nodes, FDG-PET interpretation, and clarification of the definition of progression.

Revisions

Updated 28 June 2009 Howard Hansen
Updated 20 January 2008 Howard Hansen

Updated 1 August 2008 H. Hansen