Effect of spirulina on risk of hospitalization among patients with COVID-19: the TOGETHER randomized trial.

Background: Algae-derived nutraceuticals, such as spirulina, have been reported to have biological activities that may minimize clinical consequences to COVID-19 infections.

Objectives: This study aimed to determine whether spirulina is an effective treatment for high-risk patients with early COVID-19 in an outpatient setting.

Methods: The TOGETHER trial is a placebo-controlled, randomized, platform trial conducted in Brazil.

Matched vs Nonmatched Placebos in a Randomized Trial of COVID-19 Treatments.

Importance: Matched placebo interventions are complex and resource intensive. Recent evidence suggests matched placebos may not always be necessary. Previous studies have predominantly evaluated potential bias of nonmatched placebos (ie, differing on dose, frequency of administration, or formulation) in pain and mental health, but to date no systematic examination has been conducted in infectious disease.

The Inflation Reduction Act: An Opportunity to Accelerate Confidence in Real-World Evidence in the United States.

Objectives: The Inflation Reduction Act (IRA), enacted in 2022, brings substantial reforms to the US healthcare system, particularly regarding Medicare. A key aspect includes the introduction of Medicare price negotiation. The objective of this commentary is to explore the implications of the IRA for US pharmaceutical companies, with a specific focus on the role of real-world evidence (RWE) in the context of Medicare reforms.

Quantitative bias analysis for external control arms using real-world data in clinical trials: a primer for clinical researchers.

Development of medicines in rare oncologic patient populations are growing, but well-powered randomized controlled trials are typically extremely challenging or unethical to conduct in such settings. External control arms using real-world data are increasingly used to supplement clinical trial evidence where no or little control arm data exists. The construction of an external control arm should always aim to match the population, treatment settings and outcome measurements of the corresponding treatment arm.

Adapting Health Technology Assessment agency standards for surrogate outcomes in early stage cancer trials: what needs to happen?

Introduction: An avalanche of early stage cancer clinical trials is coming. The majority of these solely use surrogate outcomes that have not been validated against a target outcome of interest (e.g.