FDA

Using Quantitative and Qualitative Research to Enhance Patient Focused Drug Development

Using Quantitative and Qualitative Research to Enhance Patient Focused Drug Development By Hannah Eccard FDA’s focus of incorporating the patient voice into the drug development process requires the life science industry to engage in new research strategies. Based on what we're seeing so far from the FDA, it appears that the agency [...]

How You Can Achieve Patient Focused Drug Development

How You Can Achieve Patient Focused Drug Development By Monica St Claire The application of a sociolinguistic lens can glean hidden meanings within seemingly ordinary communications. On the Society of Linguists website, Walt Wolfram, director of the North Carolina Language and Life Project at North Carolina State University said, “We use [...]

Federal Agency Perspectives on Clinical Trial Eligibility: Spring 2018

Federal Agency Perspectives on Clinical Trial Eligibility: Spring 2018 “Most current [breast cancer] clinical trials only enroll what I call the metastatic cancer ‘Olympians:’ the healthiest of the dying, those who are on their first or second line of therapy, who have limited metastases, who don't have brain mets, who don't have [...]

Inspire posts forward medical research in adverse drug reactions, new study shows

Inspire posts forward medical research in adverse drug reactions, new study shows Over 2 million injuries, hospitalizations and deaths in the US each year are associated with post-approval adverse drug reactions (ADRs).1 The usual method of gathering ADR data is through provider reporting.  Research suggests that health care providers tend to under-report [...]