Please Wait...

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 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.



Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

Medical Imaging of Non-Alcoholic Fatty Liver Diseases in Clinical Trials – Where Do We Stand?…
Bioclinica (21 hours ago)
Bioclinica's Electronic Data Capture #EDC has been used in thousands of clinical studies worldwide. Why? Our single…
Bioclinica (4 days ago)
Is Your Study Supply Chain Management Solution Increasing the Risk of Stock Out Situations?…
Bioclinica (5 days ago)
Here are the five questions to ask your IRT vendor. #clinicaltrials #irt
Bioclinica (6 days ago)
Over 25 years of experience, we offer world-renowned scientific expertise, regulatory leadership, and integrated te…
Bioclinica (1 week ago)
Your trial needs Bioclinica experts who can see more deeply into essential imaging data. We offer expertise in…
Bioclinica (2 weeks ago)

Latest Blogs:

Medical Imaging of Non-Alcoholic Fatty Liver Diseases in Clinical Trials
EDC Provider Selection
Site Payments Solutions
Nonalcoholic steatohepatitis (NASH) development programs
Dr. Joby John
Transformational Trends in Investigator Site Payments
Clinical Supply Chain Success: Leveraging Technology
Blood pressure monitor
Prescription box