Data law adds to cost & time of clinical trials, says ACRO
IMS’ five-year fight to keep PI data accessible has now reached the US Supreme Court. A number of groups, including the Association of Clinical Research Organizations (ACRO), have raised concerns about the impact PI data restrictions would have on clinical research.
“It would be more difficult to design clinical trials to test new medicines, identify doctors to participate in clinical trials, recruit patients who would most likely benefit from a new treatment, and compare the efficacy of new medicines to those already on the market”, said ACRO.
However, some want to restrict PI data use. IMS has fought a series of court cases to overturn PI data availability legislation passed in New Hampshire, Vermont and Maine. The Vermont law has been upheld by one court, overturned by another, and is now before the US Supreme Court.
“Vermont doctors pressed for this law because of their concerns about privacy and because they view this data mining practice as an intrusion into the way doctors practice medicine”, said William Sorrell, Vermont attorney general.
Doug Peddicord, executive director of ACRO, said: “To be clear, the data in question in the IMS case meets the standards of HIPAA (Health Insurance Portability and Accountability Act) and is not ‘personally identifiable health information’ so privacy is not the issue here.”
“A disturbing trend”
Vermont is just one small US State but its PI data law, coupled to moves in Maine, New Hampshire, and other locations, is, according to ACRO, part of a shift towards “overreaching restrictions”.
In response ACRO has spoken out against further restrictions on de-identified data. “We see a disturbing trend toward unnecessary restrictions being placed on the use of medical data, which can result in making research more time-consuming and expensive”, said Peddicord.
The Vermont law makes an exception for data used in research. However, ACRO fears “the restriction on the use of the data for marketing will severely curtail the economic incentive to gather the data in the first instance”.
Oral arguments in the case, Sorrell v IMS Health, will be heard on April 26. ACRO has filed an amicus curiae, or friend of court, brief in support of IMS. A ruling is expected in June 2011. The Biotechnology Industry Organization (BIO) has also filed a brief in support of IMS.
