There is something I just don’t get about the whole contracting-out-data-management thingy. Sometimes it's done because of lack of resources, or lack of internal expertise, which is understandable and part of a flexible business model. Sometime, though, organizations look at data management and decide it is not a core competency, and that's why they outsource it or offshore it, or whatever the flavor du jour is, and that is the part I don't get. Many don't stay with only one CRO, and the studies are spread around. Often the protocol is tossed over the wall, and the CRO is expected to develop the database, cleaning rules, CRFs, etc., using their own approaches. Sure, the sponsors review the specs that the CROs produce, but either don't have the time or else the expertise in-house to assess them for relevance, completeness, and consistency with other vendors in the study, let alone poolability with other studies in the development program. If data are not consistently defined and captured, then pooling them may not be valid, and thus conclusions drawn from the data may not be valid.
Data management is about the design of the data, about its definition and assurance of its quality, with quality meaning "fit for its intended purposes." It’s about knowing how to capture data efficiently and accurately, and in accordance with the word and spirit of the protocol. Without the data, the study drug/biologic/etc is just another pile of white powder (or whatever) sitting in a jar. The data are what tell the story of the safety and the efficacy of the treatment. The data are the basis for the label, for marketing, for answering questions from the FDA and the public, and for finding new potential indications. The data are the foundation of the whole thing.
So help me understand.
What is it about this whole process that
ISN’T COMPLETELY ABOUT THE DATA??????
How on earth can data management be a non-core competency!?
Data management is about the design of the data, about its definition and assurance of its quality, with quality meaning "fit for its intended purposes." It’s about knowing how to capture data efficiently and accurately, and in accordance with the word and spirit of the protocol. Without the data, the study drug/biologic/etc is just another pile of white powder (or whatever) sitting in a jar. The data are what tell the story of the safety and the efficacy of the treatment. The data are the basis for the label, for marketing, for answering questions from the FDA and the public, and for finding new potential indications. The data are the foundation of the whole thing.
So help me understand.
What is it about this whole process that
ISN’T COMPLETELY ABOUT THE DATA??????
How on earth can data management be a non-core competency!?
Photo: the world at night, from orbit. NASA website.
