We are quite honestly a bit unsure how to extrapolate from these data the likely sample sizes for clinical trials submitted for 510(k) clearance in connection with nonsignificant risk devices.

Neuronetics Inc. (NASDAQ:STIM) is one of the best-performing NASDAQ stocks according to analysts. On June 10, Neuronetics ...

Researchers investigated timelines for ethical, administrative, regulatory and logistical procedures across Europe.

Under the new leadership of Marty Makary, the FDA should focus more attention on the critical role of real-world clinical data — such as from health insurance databases — in the ongoing assessment of ...

The original proposal for SDG treated it as a form of multiple imputation. 100 Under the multiple imputation model, multiple data sets, say m, are synthesized for each clinical trial data set and ...

Data will guide upcoming “Lithium in Brain” Phase II clinical trials in partnership with Massachusetts General Hospital, which were announced in August 2024 October 16, 2024 08:00 AM Eastern ...

He highlighted data from the L.E.K Clinical and eClinical Pharma survey showing that 21% of phase 3 trials used site management organizations in 2023, compared to only 15% in 2021.

The global clinical trial imaging market, valued at approximately USD 1.13 billion in 2022, is projected to grow at a healthy compound annual growth rate (CAGR) of over 5.38% during the forecast ...

The emphasis on “quality by design” within E6(R3) underscores the need for proactive risk mitigation and precision in managing biospecimens and their associated data. The guidelines call for “clinical ...

On November 13, 2023, Kyverna Therapeutics announced that it had received IND clearance from the FDA for an open-label phase 2 clinical trial in 10 patients with MG for its CAR T KYV-101. 5 ...

PURPOSEThere is strong interest from patients, researchers, the pharmaceutical industry, medical journal editors, funders of research, and regulators in sharing clinical trial data for secondary ...