This case, about the claim that Merck failed to warn patients about the risk of typical femoral fracture, reaches past this suit to potentially change pharmaceutical companies’ relationship with the FDA.
The paradigm shift to more patient-centric, technology-enabled decentralized clinical trials during the pandemic has created an opportunity to strengthen patient care in research.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Informed consent isn’t as simple as getting verbal or written consent from a participant one time. Rather, it is the start of an ongoing relationship based on communication.
Creating the simplest process for informed consent benefits the potential participant by allowing them the time and resources to understand fully what they are consenting to. Through eConsent processes, research also opens the door to a more diverse population to engage in trials.
It can be vexing for them to choose among different medical options that are presented to them in an effort to meet our obligation to apprise patients of all reasonable treatment alternatives.
Informed consent is a very important issue in healthcare these days. As patients are viewed more and more as consumers, they must be informed of all the details in order to make the best decisions for their own health. But, are insurance company formularies disrupting informed consent? Before I prescribe a medication to a patient, […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Jaron Lanier is a computer scientist who thinks that Facebook should pay users for their data. After all it’s the content from individual users that has enabled the company to become a billion-dollar business ($1.81 billion in Q2 2014). Without users posting comments and pictures and links, what does Facebook have? Nothing. How do users […]