IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For May 2016
By Ed Miseta, Chief Editor, Clinical Leader
Below are my top three articles downloaded on Clinical Leader for the month of May 2016. In case you missed them, please take this opportunity to see what everyone else was learning about Merck’s efforts to be a sponsor of choice, FDAs decision on Eteplirsen, and BMS’ success in clinical trials for Opdivo.
Merck Changes The Paradigm On Clinical Trials
Patient centricity remains a hot topic in the clinical space, and generated a significant amount of discussion at the CROWN Congress in Philadelphia earlier this year. Few would argue this will be a critical factor in turning around patient perceptions of the pharma industry, and hopefully solve the patient recruitment and retention issues that have long plagued the industry. But taking all of the hoopla and discussions you hear at conferences, running it through the internal channels within your company, and generating changes that have a real impact on patients is not an easy endeavor.
FDA Panel Decision On Eteplirsen: Disappointing But A Big Step Forward
ANSM, the national drug safety agency in France, has issued a timeline of the events that culminated in the death of one trial participant and the hospitalization of five others at a clinical trial performed at clinical research firm BIOTRIAL. As was speculated by researchers at the UK’s Royal Statistical Society (RSS) last week, the timeline confirms that all six of the volunteers who were hospitalized after the study received an escalation of the dose at the same time.
BMS' Opdivo Trials: What They Teach Us About Successful Studies
Lately, it’s hard to ignore the news around immunotherapies to treat cancer. Opdivo (nivolumab) is a Bristol-Myers Squibb (BMS) medicine that has been approved by the FDA for patients with previously treated advanced non-small cell lung cancer (NSCLC), metastatic melanoma, and renal cell carcinoma. While the medicine is a welcome treatment for cancer sufferers, it might also be a textbook lesson for sponsor companies on how to conduct a successful clinical trial.
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