FEATURED ARTICLES
What You Need To Know About FDA's Clinical Outcome Assessment Compendium
One of the goals of CDER (The FDA’s Center for Drug Evaluation and Research) is to foster patient-focused drug development. As part of that effort, the agency has published a compendium of clinical outcome assessments (COAs) to promote the use of patient-focused outcome measurement in the drug development process.
-
![Do Your Clinical Trial Participants Feel Like Valued Customers?]( "Do Your Clinical Trial Participants Feel Like Valued Customers?")
Do Your Clinical Trial Participants Feel Like Valued Customers?According to Roslyn F. Schneider MD, MSc, Global Patient Affairs Lead at Pfizer, patients can often have a feeling of being powerless, and be left with the impression they are there to serve the drug development process, and not the other way around. “There are times when it seems we are asking patients for their opinions simply so we can paste them in a pre-defined place in an existing system,” she says. “That is not how a company should be treating one of its most critical stakeholders. As an industry we need to continue to find new ways to incorporate participant feedback in a way that is good for patients, their families, and caregivers. This will be beneficial for our companies and societies as a whole since all of these stakeholders are very closely aligned.”
-
![Can You Guess What This Trial Is Using To Fight Obesity?]( "Can You Guess What This Trial Is Using To Fight Obesity?")
Can You Guess What This Trial Is Using To Fight Obesity?A promising new diet may work wonders for helping individuals lose weight and fight obesity. The trial will involve taking fecal matter from the digestive tracts of healthy and thin humans, which would then be freeze-dried and put in a pill. Individuals in the study would then ingest the pills. The research does have some validity. Researchers at the Massachusetts General Hospital in Boston have discovered the microbes in digestive tracts of healthy individuals are different from those in obese individuals.
-
![Speed, Savings And Security: Leveraging The Power Of E-Signatures In Clinical Trials]( "Speed, Savings And Security: Leveraging The Power Of E-Signatures In Clinical Trials")
Speed, Savings And Security: Leveraging The Power Of E-Signatures In Clinical TrialsThe devil is in the documentation. At least, so it seems with clinical trials. Every step, decision and result of each trial phase must be inked, approved, filed and submitted to appropriate parties. Because trials are part of drug and therapy development, keeping detailed records is a must. But the sheer amount of paper-pushing can dramatically slow the pace of a clinical trial.
