The FDA has cleared Brainstorm to initiate a Phase 3b clinical trial testing NurOwn (debamestrocel) in people with moderate ...

Deepak Bhamidipati, MD, discusses a review conducted to investigate how the design of early-phase clinical trials has evolved.

Ethics and dissemination This protocol (V.5, date: 25 October 2019 ... Figure 1 shows Consolidated Standards of Reporting Trials (CONSORT) flow chart of the study. We will run this trial in six ...

The use of digital health technology (DHT) is increasing worldwide. Clinical trials assessing available health tools for the ...

This study presents a valuable meta-analysis that highlights low and highly variable breast cancer survival rates across Africa, emphasizing the pressing need for public health in Africa. The evidence ...

Furthermore, there might be ways to tweak the PAX LC Trial protocol so that more people may benefit. "The case study goes on to show that maybe the duration of the drug wasn't long enough ...

This publication details the full protocol for the pivotal Phase 3 trial to support the use of hydronidone in Chinese patients with liver fibrosis associated with chronic hepatitis B (“CHB”).

The trial protocol was approved by the institutional review board ... Figure 1 displays the patient flowchart. A total of 437 patients were screened, of whom 230 (53%) entered the placebo run-in; 28 ...

This protocol study was guided by the standard protocol items: recommendations for interventional trials. Figure 1 shows the CONSORT (Consolidated Standards of Reporting Trials) flowchart, enrollment ...

For example, an investigator’s failure to perform a protocol-required test being discovered by the study monitor during a routine monitoring visit would be a protocol deviation. It may also ...

The Draft Guidance defines “protocol deviation” as “any change, divergence, or departure from the study design or procedures defined in the protocol.” In contrast, an “important protocol ...

Placebo-Controlled Study will outline the study protocol of the Company’s upcoming Phase 2 trial evaluating bezisterim people with Parkinson’s disease who are naïve to carbidopa/levodopa ...