Sarah Fal: Who is involved in the clinical data management process?

Kumar Komuravelli: In general, it tends to be clinical data managers as well as programmers and designers. To some extent, clinical operations, clinical scientific leads, biostatisticians and IT professionals are involved when it comes to the data collection, review and integration side of things.

SF: To what extent are clinical operations involved?

KK: They have interest in the area but the main party involved are clinical data management folk as they gather site information, collect payments and patient data. They pull this from the clinical management systems and feed it into the EDC system.

While the clinical operations team also work with data, much depends on the type of data that’s needed. They would look more from an operational standpoint. They are also the owners of the electronic Trial Master File (eTMF) which relates more to documents rather than data. Other systems that fall in their remit are the CTMS and IXRS. The people that own these systems are part of clinical operations, but also have interest in tracking products.

SF: Are there any external parties involved?

KK: Yes, there are external parties involved. There is an external data acquisition group in most of the companies where the data is received by them from external partners (for example lab and ECG data) who use a database to collect data.

For instance, lab samples may be taken as part of the visit/assessment schedule and sent to the appropriate lab partner of the assigned study and the results are sent back to sponsor and CRO. This data (normally SAS datasets) then needs to be reconciled with the EDC and in some instances entered into the EDC.

Regarding data collection tools, data is entered in EDC (CRF) where external parties like Oracle or Medidata are involved in hosting the trial databases. Dataflow occurs from EDC  to SAS Programming group further to biostatisticians for analytical purposes.

SF: What would you identify as your biggest challenge in the entire process?

KK: Data repository is among one of the more major challenges. Let’s say you have three different trials for in a certain therapeutic area, you would want to combine the data from these to spot trends and look at the data more holistically. This comes down to pooling data from multiple studies. The use of data repositories tend to be limited to bigger companies like Merck or Allergan. Steps are being made to have this, however, this has not reached its full potential. There needs to be a high level of integration to make this possible.

SF: Fantastic, are there any tools that can help on the overall process?

KK: Yes, to some extent this links closely to eSource which is a major topic at the moment. There is still heavy usage of paper-based data collection. Some of this information goes to the EDC, but now they are coming up with a new approach where you’d carry an iPad or touch screen device to take all information directly. This reduces manual entry and creates deeper integration.



*Disclaimer: Kumar Komuravelli is the Director of Clinical Data Management at Mallinckrodt Pharmaceuticals. Views expressed herein are his own, and not that of his employer