Developing a Workflow Application: Clinical Data Management

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The ABC Pharmaceutical Company is a leader in the discovery, development, manufacturing, and marketing of prescription medicine. There goal is to provide a broad range of innovative, effective and safe products. There products are provided to patients through healthcare professionals around the world.

In 2004, the Company posted sales of USD 18.5 billion. Research & Development spending increased substantially and reached 18.8% of sales. The Development portfolio involves more than 100 projects - including potential new products in various stages of clinical development. 

Clinical trials are research studies which try to answer scientific questions and find better ways to treat or prevent diseases.  A clinical trial is conducted to determine whether a new drug or treatment is both safe and effective in people. Extensive clinical trails need to be conducted before being approved by the Food and Drug Administration (FDA) for sale in the United States.

Almost 50% of medical needs are still to be answered by pharmaceutical and biotechnology companies. As specialists with all the skills in bringing chemical entities to the patient, pharmaceutical companies spend half of overall drug development costs in phase II, III and IV. New drug discovery technologies and methods increasingly fill the pipeline of products going into phase I.  


In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

Bridging the gap between drug candidates and affordable new drugs is becoming a serious challenge. Reducing the cycle time will decrease the cost thereby making the drug affordable.

Process Description

The Clinical Trial Data Management contains several sub processes that provide the framework for how clinical trial data is gathered, entered, reviewed, and stored by a pharmaceutical company throughout the lifecycle of a clinical trial up until the time the data has been formally submitted to the Food and Drug Administration (FDA) for review and approval of a drug compound.  For this exercise, the sub processes of Clinical Data Entry and Review will be discussed in the context of implementing the new and improved sub-processes.

End to end, the Clinical Data Management (CDM hereafter) process contains six sub processes. Each of these sub processes are made of several tasks. The Clinical Data Entry and Review sub-processes contain approximately twelve steps combined.  Because of the numerous steps associated with the data entry and review sub processes, these tasks become tedious for the respective teams to complete.  In addition to the several steps of these sub processes, a set of data entry and handling guidelines need to be applied to each and every data point stored in the already superfluous database.  Because of the current convoluted Clinical Data Entry and Review sub processes and the inefficiencies observed (time, resources and work load), the Clinical Data Entry and Review sub processes are ideal candidates for analyzing and applying business process reengineering principles in order to gain leverage at the onset of the overall CDM process.

The Clinical Data Entry sub process assumes the kick off point of the CDM process.  Upon receiving completed worksheets from the investigators conducting the clinical trials, an internal data entry teams is poised to handle the receipt and entry of the collected data (entered on worksheets by the investigator).  The data entry team is responsible for entering, reviewing and flagging the data for the next sub process in CDM.  The data review team monitors flagged data via queries against database views that provide the information regarding the number of completed patient visits by data entry and prepares to engage in the review process.  The data review team is responsible for encoding any data terms that require FDA standardization, reviewing the results of system validations run against the collected data and is responsible for correcting any discrepancies in the data found during the review process as required.  Both the data entry and review teams perform data review and this redundancy in the process creates a bottleneck that often times pushes timelines out further for sub processes downstream.

The following diagram outlines the current data collection (at the investigative site), data entry and review sub processes correlate to one another.

The length of time it takes from the time the worksheets are received in-house and the marking of data for medical review were significant and required several resources to accomplish especially for large studies.  Several of the tasks had both manual and automated steps in order to complete the work.  The data entry staff was also responsible for providing a preliminary review of the data and mixing minor issues prior to sending it off to the data review team for a complete analysis.  There was an overlap between sub processes and needless to say, the delineation between sub processes was needed as was the review of what each of the groups was responsible for in terms of their duties.

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The current Clinical Data Entry sub process contains seven tasks before redesign of the sub process occurred:

  1. Worksheets received in-house for data entry (mail-room)
  2. Worksheets sorted by study and placed on rack for pick up (manual)
  3. Worksheets picked up for entry and sorted by patient/visit by data enterer
  4. Data Entered (Clinical Data Entry application)
  5. Data Entry completed for patient/visit and reviewed for discrepancies (errors) (automated and manual)
  6. Discrepant data verified and corrected (automated and manual)
  7. Data marked for review by patient visit (automated)

The current Clinical Data Review sub process contains five tasks before ...

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