full access: Cancer Genomics: Conducting Exemplary Trials With Biospecimen and Biomarker Components

Note: long article regarding efforts in progress

One specific area of importance to patients:

"As clinical trials become more complex, so do the concerns researchers must address. Original correlative trials have now led to a new generation of clinical trials, some of which exclude patients who do not possess the specific biomarker being studied. When these biomarker tests must be completed before enrollment onto a clinical trial, it is important that the study budget provide reimbursement for testing of individuals who are afterward deemed ineligible. Additionally, because biomarker testing is generally completed at a central laboratory designated by the sponsor, it is important that physicians know how long it will take to receive the results. If the turnaround time is 3 to 4 weeks, it should be considered whether patients will agree to wait that long to begin treatment, especially if they may ultimately be excluded from the clinical trial on the basis of the test results. Considerations such as these should be discussed in advance with the sponsor, so efforts can be made to expedite testing. The research site should also be aware of all options that can be provided to patients who are excluded from the clinical trial. Sometimes sponsors will offer an expanded access option or suggest alternative trials using the medication, important factors when enrollment onto the clinical trial is the only remaining treatment option for a patient."