Patients in fibromyalgia clinical trials are an interesting bunch. On one hand, you’ll seldom find a more accommodating and cooperative group of people. For years the condition was so poorly understood that many patients were treated dismissively by physicians who didn’t recognize fibromyalgia as a genuine affliction. And even today, the disease’s many symptoms continue...
Both understanding the role of patient advocacy groups in building better clinical trials and improving the research process mean first taking a look at the history of orphan drug development in the United States and Europe. An “orphan drug” is a drug that treats a condition that fewer than 200,000 people have. Because rare diseases...
Wearable medical devices are yielding increasingly important insights into health. Rosalind Picard, Sc.D., professor of Media Arts and Sciences at MIT, discussed the applications of one such device, wearable wrist sensors that measure electrical changes in the skin, in an informative plenary lecture we attended at the American Pain Society’s 36th annual meeting in Pittsburgh,...
In evaluating patient response to treatment of solid tumors, the nearly decade-old RECIST 1.1 guideline remains the gold standard. But the implementation earlier this year of the iRECIST guidance is focusing attention on how the many wide-ranging approaches to tumor assessment interrelate, and how they rank in relevance — today and looking forward. It all...
The most prevalent gauge of efficacy in the study of fibromyalgia drugs is — no surprise here — pain relief. But analgesic effect alone is not a sufficient measure in the eyes of the FDA, which seeks evidence of overall benefit and improvement in patient function when evaluating treatments for a condition commonly associated with...
Scott Millard of Premier Research reviews how to best operationalize fibromyalgia clinical trials in a 2017 APS Town Hall Talk in Pittsburgh, PA.
DURHAM, N.C., MAY 23, 2017 — Interleukin-2, interferon, and other immune-modulating agents have long been used to treat some solid malignancies, but their efficacy is generally limited to immunogenic cancers such as melanoma and kidney cancer. Until now. Today, multiple immuno-oncology pathways are under development, and we’ll explore this promising trend in a webinar on...
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 the...
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 a...
Both registry studies and natural history studies play important roles in rare disease research. Understanding the differences between the two types of studies and how they can be used to inform clinical development can help sponsors plan for success. Sound drug development requires a comprehensive understanding of the disease being treated. To design reliable clinical...