Sanket S Dhruva

Nov 13, 2024 | jamanetwork.com | Maryam Mooghali |Yale Collaboration |Sanket S Dhruva

Representativeness of Studies Required Under Medicare’s Coverage With Evidence Development Program Medicare beneficiaries are often inadequately represented in clinical studies supporting US Food and Drug Administration medical product approvals.1 In certain circumstances, the Centers for Medicare & Medicaid Services (CMS) covers items and services under the coverage with evidence development (CED) program, which requires patient enrollment in CMS-approved clinical studies to generate...

Jun 11, 2024 | statnews.com | Sanket S Dhruva |Rita F. Redberg

Multi-cancer early detection tests (MCEDs), sometimes called liquid biopsy tests, are a new method of detecting cancer early. While the concept is promising, these untested tests currently pose significant problems. MCEDs look for circulating DNA or cells from cancers. The goal is to detect cancer in its earliest stages in people without any signs or symptoms of the disease.

Feb 15, 2024 | healthaffairs.org | Kushal Kadakia |Vinay K. Rathi |Sanket S Dhruva |Maryam Mooghali |Claudia See |Joseph Ross | +1 more

The Food and Drug Administration (FDA) issues recalls for thousands of medical devices yearly due to safety issues. In January 2024, the Government Accountability Office (GAO) formally accepted a request from Congress, initiated by Senators Durbin (D-IL) and Blumenthal (D-CT), to review FDA’s oversight of device recalls in the wake of the far-reaching and ongoing recall initiated by Philips Respironics, which affected 15 million devices.

Aug 28, 2023 | jamanetwork.com | Sanket S Dhruva |Rebecca Smith-Bindman |Rita F. Redberg

The Need for Randomized Clinical Trials Demonstrating Reduction in All-Cause Mortality With Blood Tests for Cancer Screening In recent years, blood tests that look for circulating tumor DNA and biomarkers (termed liquid biopsies) have been developed. As Carr and Welch describe in this issue of JAMA Internal Medicine,1 these tests are being explored for diagnosis of suspected cancer, cancer surveillance after treatment, response to therapy, and chemotherapeutic selection.

Mar 16, 2023 | dovepress.com | Maryam Mooghali |Joseph Ross |Kushal Kadakia |Sanket S Dhruva

IntroductionThe Food and Drug Administration (FDA) is responsible for monitoring the safety and effectiveness of medical devices in the United States.