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NPR - To Improve Treatments, Researchers Want To Hunt For Clues In Medical Records

When you go to your doctor's office, sometimes it seems the caregivers spend more time gathering data about you than treating you as a patient.


Electronic medical records are everywhere – annoying to doctors and intrusive to patients.


But now researchers are looking to see if they can plow through the vast amount of data that's gathered in those records, along with insurance billing information, to tease out the bits that could be useful in refining treatments and identifying new uses for drugs.


Medical News Bulletin - Are FDA labels on prescription drugs reliable for clinical use?

A recent study has quantified the wide disparity between the FDA-approved labelling of prescription drugs and real-world clinical practice.

When new prescription drugs are approved for marketing in the United States, the Food and Drug Administration (FDA) provides the accompanying drug-related information. Once the drug is in use in the population, clinicians and researchers observe new indications and evidence for safety. If this information is not submitted to the FDA by the drug manufacturer, the original labelling becomes out of date.

STAT - Could FDA use off-label data for drug approvals? It’s possible, agency official says

The Food and Drug Administration might one day use data gathered from off-label uses of drugs to determine whether or not to approve the drugs for those uses, an agency division director said Tuesday.


The FDA approves drugs for specific conditions in certain groups of people and then spells out those prescribed uses on a drug’s label. But physicians can prescribe the drugs to anyone for anything, so-called off label.


Regulatory Focus - RWE Pilot Shows Promise as FDA Seeks to Leverage EHR Data

A pilot study released Tuesday supports the use of real-world evidence (RWE) to understand mortality data while highlighting the barriers to using such data in regulatory decision-making.

The retrospective observational analysis was the result of a pilot project aimed at determining whether RWE can provide early insights into patient outcomes through the use of electronic health records (EHRs) and claims data. Data sets were provided by six partners, including COTA, Flatiron, IQVIA, Kaiser Permanente, OptumLabs and PCORI.

BioCentury - Pilot Supports Real-World Endpoints as Surrogates for OS

Friends of Cancer Research released data Tuesday that support the use of real-world evidence (RWE) outcomes -- including real-world progression-free survival (rwPFS) -- as surrogate endpoints for overall survival to evaluate a treatment's long-term effects.


Vital Transformation - Podcast with Jeff Allen, CEO Friends of Cancer Research

Duane Schulthess of Vital Transformation sits down at the DIA Global conference in Boston, for a one on one discussion with Jeff Allen, CEO of Friends of Cancer Research from Washington DC.

Pink Sheet - Real-World Evidence Could Help Relax Clinical Trial Enrollment Criteria

Executive Summary

FOCR study suggests overall survival for PD-1s seen in real-world datasets is similar to results from clinical trials.


BOSTON – Results of an upcoming study on the correlation of real-world endpoints to overall survival in trials could encourage sponsors to adopt broader inclusion criteria in clinical studies, according to Friends of Cancer Research President and CEO Jeff Allen.


OncLive - The Comorbidity Checklist: New Strategies Needed for Cancer Care

Although patients with cancer have high rates of comorbidities that often correlate with poorer outcomes and complicate treatment decisions, hard data are frequently lacking on the interaction between specific regimens and health conditions.


Oncology experts are increasingly turning their attention to the disconnect between patient populations recruited for the clinical trials that lead to the approval of new drugs and individuals in the real world who are treated with those medicines. A push for better metrics to assess and manage comorbidities is also under way.

Healio - Clinical trial inclusion, specialist collaboration can improve cancer outcomes for those with HIV

Individuals with HIV are living longer than ever due to tremendous advances in treatment.


However, as survival has increased, so has the incidence of cancer. Malignancy is a leading cause of mortality for this population.

Individuals with HIV have a substantially higher risk for certain types of cancer than the general population. Typical AIDS-defining cancers include non-Hodgkin lymphoma and Kaposi sarcoma.


Cancer Today - Opening Clinical Trials to HIV-Positive Cancer Patients

In December 2017, the National Cancer Institute (NCI) announced that preliminary results from an NCI-sponsored phase I clinical trial​ showed it can be safe to treat HIV-positive cancer patients with the immunotherapy drug Keytruda (pembrolizumab).