DATA MANAGEMENT
phase 1 trials. In oncology protocols, there will often be unique adaptive cohorts designed to grow later in the study. Data managers will need to know the protocols in-depth in order to design a database that can be adaptive and flexible for any amendments. Another challenge we come across is that we will regularly encounter very sick patients who will come off the studies. End of treatments, end of studies, and death are regular occurrences in an oncology trial. Because of these varying factors, data managers must be more cautious and attentive to tracking these patients.
How can a data manager play a key role in oncology trials? Learn the technology and take advantage of modern tools. Participate in the vendor selection to better understand what each can offer and how their products can integrate with the EDC system. Get involved with the protocol design and synapsis
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“As a data manager, you will see the data differently from others. Share your experience, your knowledge, and get involved in discussions. Don’t be afraid to voice your opinions”
reviews. Get a head start on CRF development and involve the study team early. Familiarise yourself with the primary and secondary objectives of the trials, and partner with medical teams and biostatisticians to construct the SAP (statistical analysis plan). As a data manager, you will see the data differently from others. Share your experience, your knowledge, and get involved in discussions. Don’t be afraid to voice your opinions, you are the data expert.
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