Good strategy bad strategy for study monitors in connected device studies

June 7, 2019

Friday is an off-day in Israel and I try to work on projects or read.

I am now reading Richard Rumelt’s book Good strategy Bad strategy: The difference and why it matters. 

The core content of a strategy is a diagnosis of the situation at hand, creation or identification of a guiding policy for dealing with the critical difficulties and a set of coherent actions.

For starters, strategy is not pie-in-the-sky visualisation of a better world/better product/better process.  Strategy is not about wanting  something bad enough and boom it  happens. It won’t.     The essence of a good strategy is a set of coherent actions. If we perform a diagnosis of EDC operations for connected medical devices, we often see strange things going on.  As a result of the diagnosis, you can formulate a set of coherent actions to fix the problem.

EDC work flow in a connected device study

1. We see sites doing SDV on device and patient-reported outcome data in the EDC.   When the source data is digital, there is no point in performing source document verification.

2.Then you see valid EDC inclusion/exclusion with queries that the source was not filled out. (Right now,  I see 40 queries with valid EDC data but missing questions in the paper source questionnaire).  There was a site monitoring visit June 6 and the CRA raised queries related to data entered on 19-Apr-2019. These are queries 49 days after the data was captured.

I happen to know the CRA and she is great.  No questions there at all.

But why fix paper source 49 days after the patient was found to be eligible for the study and is already in treatment?  Something seems wrong with the process.    What’s going on, is that we are fixing paper source over 6 weeks after the fact. That sucks.

You don’t need deep technology to reduce the data cycle by 98%

Let’s apply Rumelt’s strategy method to EDC for connected medical device studies. We create a guiding policy:

Reduce the data cycle to 1 day from 49 days

The set of coherent actions to execute the guiding policy is:

1.Do not SDV connected device and ePRO data. There is not point in validating electronic source against itself.

2.Improve GCP compliance and save time retroactively fixing paper documents.  Just enter the Inclusion/Exclusion criteria directly into the EDC and make the EDC the electronic source according to the FDA Guidelines on electronic source

If there is a connectivity issue in the treatment room, you can use Flask Forms on your phone to enter the IE CRF directly into the EDC.

It is easy to improve the process. All you need is a good strategy.

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