Think about what could go wrong

Problems in the supply of clinical trial materials from the manufacturers can cause delays and cancellations of trials, and these unfortunate outcomes can have a number of different causes. According to the U.S. Government Accountability Office, shortages of drugs, particularly cancer and nutritional drugs, have tripled since 2006, and most of these are caused by manufacturing shutdowns, inadequate supplies of the ingredients for the drugs, or even communication breakdowns.

Other causes of plant shutdowns include strikes; for example, a strike at a Sigma Pharmaceuticals warehouse delayed shipping of drugs in Australia. Any of these can have an impact on supplies of comparator drugs or drugs used for standard of care.

Johnson & Johnson's ($JNJ) Doxil illustrates the impact of drug shortages. Doxil is a liposome-encapsulated form of doxorubicin used to treat used as a comparator drug in clinical trials. In November 2011, there were around 30 clinical trials under way that relied on Doxil. Already in short supply, the shortage of Doxil was worsened by manufacturing problems at the Bedford, OH, site of Ben Venue Laboratories, a unit of Boehringer Ingelheim and the sole manufacturer of the drug.

The lack of access to Doxil slowed Eli Lilly's ($LLY) trial of tasisulam as a treatment of ovarian cancer. It also threatened to affect Endocyte's recurrent, platinum-resistant ovarian cancer trial, which compared the combination of its experimental drug EC145 and Doxil with Doxil alone. The Ben Venue Laboratories plant also manufactured methotrexate, which is used as a comparator drug in clinical trials. In addition, Ben Venue Laboratories manufactures investigational drugs, including Clavis Pharma's elacytarabine, in Phase III trials, and the manufacturing issues have delayed the drug's development.

Think about what could go wrong
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