• Shafi Consultancy

Are these the only challenges we face in reporting clinical trials?

The key challenges programming teams face when reporting clinical trials are oversight, standards, programming environments and reusability of code. I am sure there are others and I would be very happy to hear about the challenges faced by the different organisational structures.


Assigning primary programmer and validator roles to individuals and checking status of tasks when programmers are spread across the world in multiple time zones is often both time consuming and inefficient. Spreadsheets with out of date data are often used, and many regular meetings are required to ensure the data is up to date, to communicate task allocation and to review status. In the 21st century, we should look beyond what we used some 25 years ago to manage these tasks.


There are company, project, trial as well as client standards that organisations have to maintain. Their versions and usages also have to be documented in the trials where they are used. Standards can be for data, documentation and reporting, e.g. CDISC standards, Statistical Analysis Plans and shells for tables, listings and figures. It should be clear to the programmers what is required, what is being used and how much is following standards. Obviously the more that follow, the less programming is required, allowing programmers time to spend time on complex tasks.

Programming Environment:

Automation can help to produce most of the TLFs, but standard macros and templates as well as developing programs from scratch are still required. Programmers should be able to do all these easily. Often the programming environments mean it is not easy to show traceability, to automate, or to use macros without falling into the black box trap. We should be able to automate 70-80% of the TFLs, and distribute tasks to the team members of various skill sets to both make the process efficient and to help develop the skills of the programmers.


Programmers are all too often writing programs for things that have already been programmed by others within the organisation. Ability to search what has been done is critical in this global environment. Once found, the ability to re-use them is equally important. Too often they are not re-used because they look too complicated, and this is where maximum usage of template programs and macros make a huge difference in the success of the programming team.