In a recent study, many trials leading to the approval of a targeted therapy were not fully transparent about the risk for adverse events (AEs), and most were deficient in reporting recurrent and late toxicities. Underreporting of AEs might be more frequent with targeted treatments than conventional chemotherapies. AEs associated with targeted agents persist longer may not be not fully captured by physicians. (Clinical Oncology)
Reconstruction of the “Elephant Man” trial
Shares of Intercept Pharma soar after change in protocol
Shares of Intercept Pharmaceuticals (ICPT) jumped after the drug maker announced it was changing an ongoing late-stage clinical trial for a drug that treats liver disease. Patient enrollment in the study has been too slow, so Intercept has changed protocols, drastically cutting the number of patients to be enrolled and lowering the bar for clinical success. Intercept said the changes were based on discussions with the FDA. (Barrons)
CAGED// The Cases For and Against Animal Testing
In this short film, the pros and cons of animal testing from a bioethical and biological standpoint are examined. CAGED was produced and created for a final project for Miramar College’s Journalism 202: Introduction to Mass Communications course. Enjoy!
Who are the PharmaVoice 100?
PharmaVoice 100 by Marie Jung The July/August Special Issue of PharmaVoice Magazine features 100 individuals designated by the publication as some of the “Most Inspiring” people in the life sciences, and the event celebrating the honorees took place in New York City in September. Influenced by the inclusion of adjectives Read more
Biomarkers – A New Era in Clinical Research
The CRO success stories of the next decade will be the organizations that can keep up with the latest drug development trends and harness new technologies and regulations, and increased reliance on biomarkers seems to be the way forward. Most pharma companies and smaller biotech companies have already embraced a biomarker approach to drug development, particularly in areas such as oncology, plus cardiovascular, metabolic, infectious and inflammatory diseases. (medpace.com)
San Ysidro Health Center To Enroll Patients In Nationwide Study
The Obama Administration’s Precision Medicine Initiative is a long-term nationwide study aiming to find out how people’s health can be influenced by individual differences in their genetics, lifestyle and environment. Doctors in San Diego are participating to make sure low-income patients of color are included in the research. The project’s Read more
Why a Missed Primary Endpoint Isn’t the End of the Road
In this 150-second video analysis (2 1/2 min), MedPage Today clinical reviewer F. Perry Wilson takes a closer look at two points raised in the review: the interpretation of P values that determine whether a trial outcome is negative or positive, and when it’s appropriate to look to secondary outcomes. Read more
The Primary Outcome Fails — What Next?
The failure to achieve the 5% level of significance is certainly not promising for the test treatment. Typical first reactions include the following: What went wrong? Is the treatment truly ineffective? Are there glimmers of hope? What next? Addressing the 12 questions below provides a path forward. (Table 1) (The New England Journal of Medicine)
Biomarkers triple clinical trial success rate, says report
A recent study of clinical drug development success rates found that biomarker-enabled drug programs are three times more likely to reach approval. (Outsourcing-Pharma.com)
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