Clinical trials don’t always go as planned. Even under the most watchful eye, timeline and budget issues can cause a trial to easily get off track. Missing key milestones over the life of a study can result from a number of different issues: patient enrollment, communication, site training, data quality, administrative management or execution issues. These are the trials that often find themselves in danger of not being completed on time and will likely need a study rescue.
Recognizing that your trial is off course is just the start of the process. Mitigating risk is the crucial next step in the rescue of a clinical study. Trials that experience issues stemming from human error are most likely to be in need of a rescue. Rushed deadlines, lack of communication, disorganization – the same people who get the trial off the ground could also be the ones dragging it down.
A thorough analysis must be done to get to the bottom of the issues plaguing the study. Conducting a structured and systematic review will need to be done before anything else. Where are things getting jammed up? What is preventing the trial from running as smoothly as it could be? Project managers and administrative staff need to take a harder look at the tools that they are using and the workflows that are in place. Are these providing the efficiency, clarity and accuracy that your trial needs? The clearer you can see the issues, the more effective your solutions will be.
If the problems lie in outdated technology, it’s time to upgrade. Utilizing a program that will provide your team with up-to-the-minute, real-time data increases efficiency and accuracy. Plus, it saves time and keeps you on schedule. You can immediately identify any problems that may arise and act proactively, rather than making fixes after the fact.
If the study’s issues stem from the people involved, you need to get everyone on the same page. Lack of coordination and organization can quickly lead to chaos and frustration among the team. Adequate resources, training and support are needed on the administrative side for clinical trial success. Clearly defined workflows and expected performance metrics must be established to eliminate confusion or question.
Don’t forget – study rescue is a team effort. You want to start with mapping out possible plans of action and then conduct a strategy meeting with the entire team. It is important for everyone involved to come to an agreement, to understand the new implementations and to be comfortable. This clear cut plan of action will define performance metrics and establish appropriate parameters that let everyone know the range in which they should deliver. Anything that falls out of that range is an indication of a potential root problem.
If your clinical study has found itself off track and in need of a helping hand, Map & Story can be your rescue. We will help get to the root of your issues, re-establish your goals, and set you up a plan to carry you through to success. Contact us here!