You Are Misunderstood

You are a CRC or CRA. You are swamped with paper. Your life is paper. Charts, CRFs, Labs, Reports, Queries. Pharmaceutical companies ¡© the people paying for the clinical research which is your livelihood ¡© think you are afraid. They think you prefer to work with all that paper rather than be faced with that “frightening” contraption, the computer. They think you won’t use it. That you can’t use it. That you’re not smart enough, or creative enough, or innovative enough. They don’t realize you are already using computers in your home, office or site. They don’t realize that among yourselves, you are imagining your own computer solutions ¡© drawing dreams on a paper napkin, or programming your own applications with a spreadsheet or word processor. They don’t realize that, in fact, many of the most active research sites have already used EDC tools, and depend on computers for study tracking, and are willing to use their computers more, if only the software was improved. Pharmaceutical companies have convinced themselves that you are too busy, too rigid, or too disinterested to learn how to use technology to replace the paper covering your desk. You are misunderstood.

You are ignored. You are a site director or investigator. When a pharmaceutical company is considering the design, acquisition or implementation of a new computer application for clinical research, you are ignored. Yes, you will be expected to use it, and they will be impatient when you find it hard to use or make errors, but you will not be asked about it while they are building or buying it. Several informal surveys of pharmaceutical company application projects, whose use involved the investigative site, have found that despite months of meetings, planning and design debate, no site was ever invited in to comment on the application, explain the work environment, or communicate their ideas for how computers can improve their daily real-life work. You need to make yourself heard ¡© in conferences, in meetings with your clients, in your professional associations.

You are mistrusted. You are a clinical project manager, whose responsibility to your company is to get this new drug out on time, on budget, or kill it before you spend too much time on a dead end. The site mistrusts you for checking up on them all the time, and for your obsession with the timetable instead of the drug. Your data management colleagues think you don’t appreciate them, and that you will try to go around them to use new technologies, or use a new CRO, just to avoid them. But you hold more power than anyone to change things, and many of the improvements in the process have come from the vision and innovation of individual project directors.

You are resented. You are the clinical data manager, the protector of the data, the data upon which the sponsor’s submission will succeed or fail. You established detailed SOPs, you enter the data from the CRFs, and enter it again. You check the data over and over, spending hours ensuring cleanliness, proper procedure, and rigorous security. You struggle with outdated computer systems, with code held together with gum and rubber bands, and yet you get the job done every time, and the submissions are completed. Through it all, you raise concerns and push back on vague ideas for improvement that have holes in them like craters. You protect the data against unproven technologies for the sake of the company. But the world is not standing still around you, and if technologies or processes are inadequate you must nurture those vendors or colleagues who can join with you to help.

You are in the middle. You are the CRO, that extra staff, the outsider brought in to carry the load the sponsor cannot handle themselves. You see the clinical research process with an outsider’s eyes, yet you get your work from someone asking only for performance, not innovation: “Do it for me, my way, as fast as you can.” You hear the misunderstood study coordinator, you see the ignored site, you get your work from the clinical project director, you understand the concerns of the clinical data manager. Somehow, you have to make sure all these players work together so that your project is a success. In fact, many CROs have proven their value-added in just this manner, achieving success where the sponsor alone could not.

We all need to understand. We all need to respect each other’s responsibilities, and yet not be stalemated into inaction by our sensitivity. The clinical research process is serious flawed; proper use of enabling technologies is critical to improving this process. Too often, technologies are not adopted because key users are ignored, or key staff erect obstacles based on sincere professional beliefs. The consensus to move forward, which senior management so wishes it could find, remains elusive. This is fatal. Understanding each other’s perspective is an important first step to joining together for change. We all must trust each other, to change together, to step off the line and move, with enthusiasm and mutual respect.