Medical trials are the trailblazers in modern medical science. Without them, there is no sure-fire way to fully understand the indications and contraindications of a new drug or treatment method. Without clinical trials and the people who run them, we wouldn’t have gotten a COVID vaccination as fast as we did, smallpox might still be running wild, and polio may be a common disease.
Setting up a clinical trial is no mean feat; the amount of admin, paperwork, emails, phone calls, and information needed and created is absolutely staggering in most cases. All this information being passed back and forth between patient and doctor or nurse, and the scientists who work in the trial lab, can quickly go astray. Losing even one small and possibly insignificant piece of information can be the undoing of an entire trial, which means lost work hours and a lot of money down the drain. To successfully implement all phases of a clinical trial, you’ll need a working clinical trial management system; a hierarchy, set roles, and officially designated ways of recording and storing data so that all of the information that trial staff or investors need is available at the touch of a button, and everyone is clear on their role in the trial. Let’s take a look at some simple guidelines that can help streamline the whole process.
The most vital thing in any clinical trial is the information that is collected from the tests carried out by the trial staff. So keep this in order and make sure that nothing is lost or mislaid; you need a reliable admin system. Break your administration down into the following subsections:
1. Integrations and Interfaces. Trial techs, doctors, scientists, and patients all need a reliable system where they can input data; a simple user interface is best. This information will go from the trial clinic to the review committee overseeing it.
2. Analytics and Reporting. Manually creating reports is a massive waste of time that could be better spent on the trial itself. Hire tech support if you need to, but be sure that you have a system that can generate accurate analytics and reports on a daily, weekly, and monthly basis.
3. Billing/ payment portal. You will submit all your financials to the review committee along with your findings, so be sure that you have accounting/billing/payment software in place to track all your numbers.
Communication is another administrative key to running an adequate clinical trial. All findings MUST be compiled into reports, newsletters, or emails on a regular basis, and all trial staff and patients should have access to all the necessary information at all times.
It’s best to have very defined roles within your team to avoid duplication of work, unnecessary confusion, and time-wasting during the trial. We suggest the following positions as a basic template:
It’s recommended that all primary trials have one dedicated trial manager, though finances often make this a challenge. This role steps in at the earliest phase of the trial and assists with design to keep the project flow smooth and logical. Streamlining a project from the start like this may save time and money in the long run. A trial manager is also responsible for overseeing the diversity of the project, and their basic functions and assets would be:
A project planner’s role is short-lived but vital to the success of a trial. Though the Manager may assist in developing the plan, the bulk of the responsibility here will lie on the shoulders of the Project Planner. Having your Trial Manager present in the planning stage is essential so that they have a good understanding of the Project Planner’s goals and the flow of the trial to pass along to other team members. A Project Manager needs to map out the details of the trial from start to finish, encompassing all of the following phases:
The number of people involved in a clinical trial is enormous, and the trial needs to be relevant to every person involved at every stage and level. This applies especially to doctors and nurses as they are the most likely to be in the best position to recruit participants for the trial. Having a group of collaborators who feel well informed and on the same page is the only way the process will run smoothly. Arranging newsletters or meetings that run on a weekly or monthly basis, depending on the needs and duration of the trial, is an excellent way to keep all collaborators adequately informed and feeling like an appreciated part of the undertaking. Provide any necessary training for collaborators to be up to date on the technology and drugs used in the trial.
These basic systems and roles will help you keep a handle on a large number of staff and participants, as well as the volumes of information that are collected during the various stages of a clinical trial. Some simple planning steps will go a long way to ensuring organizational success.