Introduction/Background
KANDEH
GLOBAL (a fictitious contract research organization) is a proven and committed partner to drug developers and medical device
manufacturers looking to bring innovative new products to market. Its
patient recruitment service focuses on an array of activities leading to
filing clinical trials. Despite these recruitment tactics and activities, the
problem of patient recruitment continues to grow at an alarming rate due to the
limitations and inefficiencies inherent in traditional patient recruitment
methods. Doctors, who patients trust to refer them to clinical trials, often
cite limited time, lack of support staff, lack of awareness of trials, and
complex enrollment procedures as reasons for not recruiting patients for
trials. Normally, it often takes longer than planned to complete a trial due
to difficulty recruiting enough patients in a timely fashion.
Recent
studies by Gartner demonstrated that improvements in automating clinical trials
processes can improve efficiency by 30-50 percent and result in cost savings of
$5.8 to $6.6 billion.[1]
A software solution integrated with the provider’s health information system to
alert doctors to the existence of a clinical trial that some of their patients
might be eligible for overcomes those limitations to speed and improve the
recruitment thereby increasing business.
Business
Objective
Use
of a clinical alert system integrating with provider’s EHR systems is expected
to reduce study start up times by 70-90 percent and reduce overall cycle time
for a project by 60 percent. This amounts to an estimated cost savings of about
$6.7 million per study and about 6 months of recruitment time per study.
Current
Situation and Problem/Opportunity Statement
Unfortunately, the identification and recruitment of subjects on a busy clinical practice can be difficult. In order to successfully recruit patients, physicians engaging in traditional recruitment have to remember which local clinical trials is active, recall the trial details in order to determine the patient eligibility, take time to explain trial details to potentially eligible patients and often take more time to perform other recruitment activities. Doing all this while also attempting to provide the individual patient with good care during a short clinic visit can be difficult. KANDEH GLOBAL has an opportunity to breaking down barriers for provider’s participation in clinical trials and maximize profit by automating these time-consuming and error-prone manual tasks.
Critical
Assumption and Constraints
The
proposed clinical alert system must be an invaluable tool in KANDEH GLOBAL’s
patient recruitment endeavor. The product must be able to pay for itself within
one year by shortening the time it takes to recruit the required number of
subjects for a study, reducing the rate of screen failures and protocol
violations that often result into site closure and overall speed up the time it
takes for a clinical trial. The project management director must lead the
effort and the team must include participants from several parts of the company
including patient recruitment and Software Development. Also there must be
participants from our clients, physicians and site monitors. The new system
must integrate with the existing information system especially electronic
medical record of provider organizations that will also serve as clinical
sites. The technology must be easy to use by physicians and be able to
interface with other systems to be able to send secure messages to site
coordinators.
Analysis
of Options and Recommendation
Three
options were examines for addressing this opportunity:
1.
Continue the present manual process - Consistent with KANDEH
GLOBAL’s commitment to innovation, consistently questioning the status quo
and seeking opportunities for continuous improvement, doing nothing to improve
the existing patient recruitment system is not an option to consider.
2.
Purchase vendor driven electronic medical record - A vendor
driven EMR with clinical alert system is not cost effective and may not fit our
specifications without significant customization leading to higher cost. It
will take longer time and cost maybe five times more to implement a complete
EMR solution for providers
3.
Develop a product in house using our software development
department - Many healthcare organizations are now investing in EMR and
therefore it would be prudent to develop a software solution using internal
resources that can interface and interoperate with providers’ existing health
information system. Based on discussions with stake holders, this is our
recommended alternative.
Preliminary
Requirements
The
Clinical alert system must be able to interoperate with the provider’s
computerized health information system. The system must be able to trigger an
alert to pop up whenever care provider accesses or enters the records of
patients with characteristics that match criteria related to a specific
clinical trial underway.
Care
provider must be able to ignore the alert or respond to it in one of three
ways: refer the patient to the trial (with the patient’s permission), indicate
that the patient wasn’t eligible, or indicate that the patient wasn’t
interested in taking part in the trial.
When
the doctor referred a patient, the system must be able to send a secure message
to the person in charge of recruitment for the trial. The message must include
confirmation that the patient had given his or her permission for the trial
coordinator to view the patient’s electronic chart, and also provide a link to
the chart.
Budget
Estimate and Financial Analysis
There
is not enough information available at the present to come up with an estimated
budget. Initial analysis reveals that most of the cost will go into planning,
research and development and personnel hours for project management team and
development. Effort is ongoing to meet with various stakeholders and develop a
detailed financial analysis and budget estimate.
Schedule
Estimate
A
proof of concept must be developed within six months and development work
begins after one year of preliminary analysis and ready for unit testing within
a year. There is an assumption that the new system will have a useful life of
at least five years.
Potential
Risks
First
and foremost, there must be providers who will agree for our software to
interoperate with their electronic medical record for the solution to work.
Additionally, there must be cooperation from EMR vendors to be able to tweak
their product if need be so as to integrate with our solution. Also there must
be interest on the part of care providers to participate and respond to alerts
positively. There is some risk involved in the type of system developed that
will first be able to integrate, interface and interoperate with the existing
health information systems of providers. There is risk of security and privacy
with patient data making some providers organization unwilling to accept an
outsider querying their data. The main business risk is investing all the time
and money in developing a product without realizing its benefits.
© 2010
© 2010
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