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Oncology Practice - ASCO calls for expanding clinical trial eligibility

The American Society of Clinical Oncology and Friends of Cancer Research have submitted recommended language to the Food and Drug Administration for ways to expand eligibility criteria for cancer clinical trials.

 

The recommendations address five specific areas that were identified as most likely to restrict participation, but least likely to affect the safety of participants, and include minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.

 

Inside Health Policy - Device Makers: FDA Expands On Concepts In Lab Test Oversight Bill Draft

Representatives of the device industry praised FDA for expanding on concepts included in a diagnostic test oversight bill floating on Capitol Hill, such as creating efficient, predictable pathways to market for diagnostic tests; accrediting third-party organizations to help with the review process; and recognizing the effect of special controls, which exempt certain in vitro clinical tests from premarket review.

 

The ASCO Post - ASCO and Friends Submit Recommendations to FDA Aimed at Reducing Barriers to Clinical Trial Participation

ASCO and Friends of Cancer Research (Friends) have submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO and Friends collaboration to broaden eligibility for participating in clinical trials by addressing five specific areas: minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.

 

Regulatory Focus - ASCO and Friends of Cancer Research Draft 5 Guidances for FDA

The American Society of Clinical Oncology (ASCO) and Friends of Cancer Research have drafted five US Food and Drug Administration (FDA) guidance documents focusing on cancer clinical trial eligibility criteria for patients with brain metastases, HIV/AIDS, organ dysfunction, prior and concurrent malignancies and minimum age for enrollment.

 

Bloomberg - Cancer Clinical Trial Proposal Could Open Door to Thousands (1)

  • Groups ask FDA to issue five guidance documents to increase clinical trial eligibility for cancer patients
  • Trials could open to patients with HIV, spread of brain cancer, teenagers

 

New cancer therapies could reach patients more quickly under a proposal by two cancer groups to increase access to the clinical trials that are essential for FDA approval.

Pink Sheet - US FDA Wants More Examples Of Real-World Data Use

Executive Summary

CDER Director Woodcock says for regulatory purposes, using real-world data likely will remain a case-by-case decision.

 

The US FDA does not appear ready to add indications to drug labels solely based on real-world evidence, even if the correlations to clinical trial data are strong, but still wants the experiments to be done.

 

Bloomberg - Pandemic, HHS Funding on Congress’ Post-Summer To-Do List

Health-care legislation may take a back seat in Congress as Trump’s pick for the Supreme Court and must-pass spending bills will dominate the debate on Capitol Hill.

 

The House has already left for a month-long summer break; the Senate is off the week of Aug. 6 but otherwise is in session. Congress will have about six weeks to get work done between the time both chambers convene after Labor Day until they leave again to campaign for the midterm elections, with the House in session only 19 days.

 

GenomeWeb - Guardant Silent on TMB Plans as Study Adds Evidence for Immunotherapy Prediction in Blood

A new study this month has added to the so-far scant data available on the ability of Guardant Health's Guardant360 assay to predict responsiveness to immunotherapy using a blood-based signal to infer how highly mutated a patient's cancer is.

 

Becker's Hospital Review: How EHR data can inform better treatments: 5 things to know

Medical experts are turning to EHR data, coupled with billing records, to help refine treatments and find new uses for drugs that have already been approved, according to NPR.

Here are five things to know:

 

Facts Herald - Researchers are looking forward to find the medical records for improved treatment

When we go to the doctor. Then the doctors administer the problem and try to reach the possible best treatment possible for a certain problem. Sometimes you will feel that the doctor is spending more time to know and collect the data about you rather than giving you some prescriptions.

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