ASCO defines meaningful

Share this article:

The American Society for Clinical Oncology is putting a definition to the FDA's term “clinically meaningful outcome.” BioCentury reports that the professional organization published its recommendations in the Journal of Clinical Oncology and developed guidelines for what constitutes "meaningful" in trials for pancreatic, breast, lung and colon cancers.

The group used overall survival as the primary endpoint and recommended a benchmark, such as establishing a period of 4 to 6 months, as the minimum median OS improvement for untreated, metastatic, triple-negative breast cancer.

The group also said the experimental treatments should not include a higher toxicity than current treatments.

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.