By Heidi Goldstein
Everyone has an important role to play on the clinical trial team including colleagues from data management, clinical, medical, programming, statisticians, medical writing, and regulatory affairs’ departments. Not any one individual group could get everything done from start to finish, nor can the end-product be a success if each group just works on their own piece and passes the information on to the next when their part is done.
A critical piece to being able to provide results, as a team, is to make sure everyone is talking to one another right from the beginning. When should the programmer and statistician become part of the conversation? It is important that early on the programmer and statistician are included in the protocol discussions.
If the data are not collected in a format that can be summarized and analyzed appropriately, then all bets are off when it comes to writing up the results.
Data management can create the best-case report forms (CRF) but they might not always frame the question to ensure the right information is being collected. For example, data management might include a free text field rather than a drop down. This can cause havoc with analyzing the data. Free-form answers may result in having to manually group the data together due to spelling differences, abbreviations, etc.
To further explain, let’s say there is a category of the CRF called “Body Location of Infection”. This can be further completed by having the medical specialist provide a basic set of answers that are expected to be considered appropriate responses to the question. This further enhancement along with an “Other” field will do quite well. This will reduce the number of records that need to be manually reviewed for grouping purposes.
The statistician and the programmer have the insight to translate what information the study needs to obtain and in the best format for collection purposes.
Once team members understand how each piece of the puzzle fits together and how the roles intertwine, it is much easier to get to the end goal of a locked database and clinical study report in an expedited fashion.
If everyone is working together right from the start – protocol design – the team can plan for the topline report along with the full study report prior to database lock. Then, the actual results are truly just being plugged in along with the interpretation in the results section to finalize the documents.
In conclusion, the statistician and programmer can add so much insight to the team beyond just producing summary tables and outputs. Their minds think about the intended use of the information and what needs to be done to get there.
It is best to have a group meeting during protocol design to learn about the study together and to ask questions early on. The half-day of planning to set a timeline will move the study along as quickly and smoothly as possible. Everyone on the team has an important role to play and you don’t want any part of the team sitting in the locker room until it is their turn at bat.