The Use of Electronic Medical Records for Clinical
Trial Recruitment
About EMRs
With the advent of the HITECH Act and Meaningful Use, EMRs
(electronic medical records) have become very popular among practicing
clinicians. The technology enables medical providers to chart patient data into
structured fields. This allows information to be easily retrieved for analysis
and reporting. Another major advantage of the EMR is the ability to provide
clinical decision support (CDS). Rules can be set to alert or inform about
patient clinical information that would affect treatment at the point of care.
Rule parameters are configured on a settings screen and the rule is run on
patient data captured in those structured fields. One example of CDS in action
is an OB/GYN clinic that set for an alert to come up for every woman that was
overdue on her PAP smear based on age, prior history of PAP abnormalities and
family history of cervical cancer. EMRs and CDS can play a vital role in
clinical trials.
Clinical Trial Enrollment
Clinical trials are divided into the following phases: 1)
using healthy subjects to test for drug safety 2) using a larger group healthly
subjects tested for drug efficacy 3) treatment and control groups involved in a
randomized control trial 4) post marketing surveillance. The enrollment requirements significantly
increase in each phase (see table below).
Table 1. Typical Enrollment Estimates of Clinical Trials1
Phase
|
Subjects Needed
|
1
|
20-100
|
2
|
100-300
|
3
|
300-3000
|
Some reasons why recruitment and retention of subjects for
clinical trials presents a challenge include:
1)Finding patients that meet
the criteria and finding them quickly. The study design specifies very clearly
who does and does not quality for trial participation. Also, requirements
change based on the phase of study. These inclusion and exclusion criteria are
very strict and need several levels of approval (ie. IRB, sponsor,
investigator) before any exceptions are
made.
2)
Patient interest. Many patients may not elect to
be part of a trial when they otherwise had there been better explanation about
the drug being tested or condition being treated. Furthermore, some patients
are just too scared to be part of an “experiment” and are not convinced by all
the precautionary measures that trial staff explains they have taken.
Conclusion
It is true that not all patients are suited for participating in
clinical trials. Also, despite all the information and intelligence available
at the point of care, some providers may choose not to use the EMR to help with
trial recruitment. Nevertheless, the fact remains that clinical trial
enrollment is a big issue and the EMR with its CDS and other features can help
in this endeavor.
In the next article, I will go through an example of how a rule
is set up in the CDS module of a typical EMR and give some real-life case study
examples of organizations that have leveraged this technology to help them
successfully recruit for their clinical trials.
References:
1) wikepedia
2) http://www.promodel.com/solutions/pharma/clinicaltrials.asp
3) http://www.pdpipeline.org/2011/clinicaltrials/recruitretention.htm
Electronic Records are very reliable. No errors in transcription, very easily retrievable and transportable
ReplyDeleteThis is an interesting perspective about electronic medical records technology. In fact, it is the first I've read where EMRs potential to expedite the clinical trial process has been discussed. Thank you for this information.
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