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How Will the Stimulus Package Affect Clinical Research?

To borrow from Oprah, here is what I know for sure:

  • Each physician could receive over $48,000 from Medicare, or $65,000 from Medicaid, by implementing or already using Electronic Health Records (EHR) (See article).
  • To qualify, the EHR system users must be a ‘meaningful user'. This means users should be trained on how to use the system and must use it in a meaningful way such as by using electronic prescribing, exchanging data with other systems and reporting on quality and safety measures. (Full HHS overview of meaningful use here).
  • Government will take a leadership role in developing standards that allow for the electronic exchange and use of healthcare information.

I've been trying to figure out how this will affect the future of clinical research. Here are my thoughts so far, and yes, I do think in bullet points!

Implication on Clinical Research:

  • Study sites will be using EHR. But all the sites in a clinical trial will not be using the same EHR. What will this be like for the monitor who has to visit 10 different sites that use six different EHR systems? Will the monitors even be allowed to login? What will source verification look like?
  • The data in an EHR isn't exactly the same as what is needed for clinical trials. For example, in the EHR would be listed all surgeries for a patient, where the clinical trial protocol may only call for surgery relevant to a certain indication. All of a patient's medication would be listed, but perhaps only the medication taken within the past 30 days may be collected for the clinical trial.
  • Clinical trial data isn't always represented in the EHR. An example of this is drug accountability showing compliance with a study drug. So, what is the source for this data?
  • CDISC and the Integrating the Healthcare Enterprise (IHE) have developed technology that is used to push forms into an EHR called Retrieve Form for Data-Capture (RFD) (See full CDISC article). This technology can be used to collect clinical research data within an EHR and pass it out to an external system such as EDC. BioClinica has exhibited this technology, so it does work and it is real. How is this going to play out? Is this the solution to pulling data from EHR to EDC?
  • Physicians are saying that the HITECH Act is turning them into an IT shop. (Referenced by article on Boston.com). They must buy hardware and software, provide training, figure out disaster recovery plans, and deal with installs and updates. Is this how we want our physicians using their time?

I welcome comments, opinions and thoughts on any of the items above.

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