“Complete Your Clinical Trial With Our File Data”

Clinical trials that support new drug development can cost over a billion dollars.  A new industry has popped up – data collectors and aggregators that provide digital data from their files as evidence in pharmaceutical clinical trials.

The gold standard in a clinical trial is the randomized controlled experiment.  In the classic design, one group is given a new drug therapy, while another group is given a placebo or, more likely, the standard prevailing therapy.  Evidence of how a completely new drug performs typically must be derived from the treatment group in an expensive experiment. However, companies are now offering vast stores of data from which the control group may be drawn.

Iqvia, Inc. collects and markets prescription and health data, and has several projects underway in which this information is provided to pharmaceutical companies involved in clinical trials.  Patient recruitment is a big expense in clinical trials, and is unavoidable for the patient group that is receiving a new drug therapy. However, for the control group, a company like Iqvia can supply data on how patients on a standard existing therapy are doing, yielding big savings on several fronts:

• lower patient recruitment costs 
• lower administration costs (fewer patients overall)
• faster time to market

These savings are amplified for relatively rare diseases, where patgient recruitment takes longer.

Two other companies with a similar line of business were recently acquired by Roche Pharmaceutical:

• Flatiron collects data on cancer treatments from software that it provides to cancer clinics
• Foundation Medicine obtains data on patients’ cancer tumors from its laboratory testing

Some analysts sound a note of caution – the beauty of a RCT is its ability, via randomization, to wash out factors not related to the treatment being tested. When the control group is not subject to the same conditions as the treatment group, this assurance is lost.  However, data gained from files, as opposed to a “live” control group, may still be “good enough,” particularly when taken in conjunction with other evidence. In 2016, the U.S. Congress mandated that the FDA actively consider alternative sources of data, other than strict RCT’s, as a basis for drug approval.