Mapping the ethical landscape of digital biomarkers: A scoping review.

In the evolving landscape of digital medicine, digital biomarkers have emerged as a transformative source of health data, positioning them as an indispensable element for the future of the discipline. This necessitates a comprehensive exploration of the ethical complexities and challenges intrinsic to this cutting-edge technology. To address this imperative, we conducted a scoping review, seeking to distill the scientific literature exploring the ethical dimensions of the use of digital biomarkers.

From Research to Policy: Unveiling Dementia Prevention Efforts in Switzerland.

Recent research has challenged the notion that dementia is an inevitable outcome of age-related cognitive decline, highlighting the possibility of preventing or delaying onset by addressing specific risk factors. This paradigm shift suggests that prevention through lifestyle modifications and early interventions is possible, potentially averting millions of cases worldwide. This study explores the translation of scientific evidence on dementia prevention into public health policy in Switzerland.

Accelerated drug approval: Meeting the ethical yardstick.

Drugs addressing unmet medical needs can change the lives of millions. Developing and validating new drugs can, however, take many years. To streamline the assessment of new drugs, regulatory agencies have long established shortened review pathways.

A defense of surgical procedures regulation.

Since the advent of drug regulation in 1962, regulatory agencies have been in the practice of using strict standards to test the safety and efficacy of medical treatments and products. Regulatory agencies, such as the FDA, demand two full-fledged Randomized Clinical Trials demonstrating the safety and effectiveness of drugs to grant its marketing authorization. On the contrary, surgical treatments are left completely unregulated.

Genuine versus bogus scientific controversies: the case of statins.

Science progresses through debate and disagreement, and scientific controversies play a crucial role in the growth of scientific knowledge. However, not all controversies and disagreements are progressive in science. Sometimes, controversies can be pseudoscientific; in fact, bogus controversies, and what seem like genuine scientific disagreements, can be a distortion of science set up by non-scientific actors (e.

More Than One Way to Measure? A Casuistic Approach to Cancer Clinical Trials.

Testing new oncological treatments in the era of personalized medicine is raising many challenges to the current regulatory paradigm. In particular, randomized controlled trials (RCTs) have proved to be inadequate for testing targeted therapies. Nonetheless, the Food and Drug Administration (FDA) still requires them to grant market approval.

[Reliability of biomedical research.].

In the last century, use of statistics became widespread in biomedical research, making medicine more scientific. However, the misuse of statistical methods may have a negative impact on the reproducibility of experiments, which instead should be at the core of scientific method. The consequence is the so called "replicability crisis", which can affect the reliability of scientific results: if one cannot replicate a published finding, she would hardly trust it.