Protecting Identity in the New Digital Age

Now that HITECH has been able to increase the adoption of electronic medical records (EMRs), the focus is on interoperability. The market has been flooded with various EMR and PM (practice management) systems but how do they communicate? The challenge of interoperability is being addressed aggressively as we go into Meaningful Use Stage 2 and Health Information Exchanges. However, according Jitesh Chawla, MD the piece that might be forgotten is maintaining patient privacy in this new digital age.

As the nation progressively implements electronic healthcare records, stakeholders have uncovered an elephant in the room – how to implement patient identity and integrity solutions. Linking an individual’s electronic health records across disparate systems, many suggest, will more likely than not require a unique patient identifier. Yet from a policy perspective, implementing this identifier has been extremely difficult. Medical banking, or the convergence of banking and heath IT systems, is spawning new ideas that could impact this difficult area. New forms of efficiency in payment processing may yield a technology platform for managing digital identity by banks that could also be used for healthcare.

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Then please post comments and join Dr. Jitesh Chawla for an interesting discussion on this topic.

The Use of Electronic Medical Records for Clinical Trial Recruitment

By Jitesh Chawla, MD.

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

  Since clinical trials can account for at least 50% drug development costs, which may run up to 1 billion dollars per product, delay or cancellation of a trial due to inadequate or late enrollment is very costly². Once source cites a company lose from $600,000 to 8 million per each day a trial is delay³. Furthermore, with increased government regulations of the pharmaceutical industries and fierce competition, many drug companies cannot afford any major delays or a cancellation.

Challenges and Possible EMR Solutions for Trial Recruitment

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.

The beauty of the CDS feature in the EMR is that each inclusion/exclusion criteria can be put as a separate rule. Furthermore, the patient reminders feature can cause a pop-up window to appear every time that rule is satisfied. Secondly, there is no better person than the patient’s provider to convince them that trying an experimental treatment might be the best option and that the benefits outweigh the risks. The relationship between provider and his or her patient is a unique one and cannot be replaced by any clinical trial staff member. EMRs have a patient education button that contains information about disease conditions and can be customized such that details about the clinical trial can be included.  Providers can go through the education sheet with their patients.

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