ASCO urges industry to share real-world data for clinical trial efficiency

“Conventional clinical trials are becoming obsolete,” ​American Society of Clinical Oncology (ASCO) executive Richard Schilsky told delegates last month, arguing that an increasing number of cancer drugs and indications​ is forcing the industry to re-think clinical trials.

With more than 800 new cancer drugs in development – many of which target rare genotypes – it is no longer possible to conduct randomized clinical trials in every population, said Schilsky at the BioPharma Ambition Conference in Dublin, Ireland.

“We cannot learn everything that remains to be learned about all the various subtypes of cancer, by doing individual, prospective clinical trials about each subtype.​

“We have to rethink the way we do clinical trials, in order to design clinical trials that are appropriate for the patient populations and the biology that we're trying to study,” ​he said. ​

As a result, Schilsky urged delegates collect and share information over the entire lifecycle of the drug: “Learning needs to combine trial data and real-world data.”​

The executive argued that firms do not need to know everything they eventually would like to know about a drug, at the time of market entry. While there is certain information required in order to justify market entry, there is a lot of information that can be developed about the drug in the post-market phase, he said.