Author Archives: Tom Laage

In 1978 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued the Belmont Report, which has since become a pivotal document in medical research ethics. This report pointed to three unifying ethical principles that must be followed in clinical research: respect for persons, beneficence, and justice, which are considered fundamental forRead more

Adaptive design is a type of clinical trial methodology that incorporates prospectively planned opportunities for modification of one or more aspects of a study’s design or its hypotheses based on interim analysis of study data. Explicitly planning these pre-specified changes helps to maintain scientific integrity while also introducing greater flexibility in the clinical research environment. The majorRead more

Dr. Thomas Laage,  Director, Product Development Consulting and Regulatory Medical Writing Support shares more about his participation in MIT’s Hacking Medicine Grand Hack Weekend. As I mentioned in my last post, I was excited to participate in MIT’s Hacking Medicine Grand Hack. I paired up with two other attendees to develop and pitch our idea to theRead more

Dr. Thomas Laage,  Director, Product Development Consulting and Regulatory Medical Writing Support tells us about his experience with MIT’s Hacking Medicine Grand Hack Weekend. It started with an email from Dan Morden, a young biotech entrepreneur in Cambridge whom I had met during a business call several months ago. “MIT’s Hacking Medicine is holding aRead more

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