Category Archives: Clinical Development & Medical Affairs

A “Like “ for Using Social Media in Clinical Research

Recently, I was astonished by the conversation taking place at a Massachusetts Biotechnology Council (MBC) Forum on the topic of using social media to encourage open dialogues with patients and patient advocacy groups. Social media has become an effective method for patients to connect with one another and also to key opinion leaders and experts…
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Registry Principles and Clinical Evidence

Core Principles for a Successful Registry. Research institutions, patient advocacy groups, and biopharmaceutical companies, especially those conducting research in rare or orphan diseases, are launching patient registries at an ever-increasing pace. Registries are valuable research tools, as illustrated by the diversity in their sponsors, objectives, and target audiences. They can span the research continuum from…
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Patient Registries: A Smart Investment for Rare Disease Research

In the current health care environment, marketing approval for a new drug is a critical milestone, but it may not guarantee that your product realizes its full potential after launch. This is becoming truer now for rare (orphan) disease indications in which the market sizes are already very small. The challenge: the race for a…
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Gathering Clinical Evidence In Orphan Indications

Given the very small patient population and even smaller number of investigators associated with clinical trials in orphan indications, every research participant and every piece of data is critical in building the required clinical evidence to support new drug treatments. To accomplish this objective more easily, sponsors should consider the many advantages of starting this…
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