New medical approaches need to be tested out to determine if they work. The research to find solutions for preventing, screening, diagnosing, and treating diseases is carried out through clinical trials. Not every trial is successful, and the ones that succeed share a common element: they have strict clinical trial management.
Importance of Effective Management in Clinical Trials
Trialists have asked for bigger randomized controlled trials for decades. Such trials produce evidence that could guide clinical practice. However, the issue of how to manage trials like these barely get a mention.
One of the reasons many trials fail is mismanagement. For a clinical trial to succeed, it must have structure and be approached in a business-like manner. After all, many elements are shared between conducting a trial and running a business: time, money, and people are involved.
Just like a business, good management practices should be implemented from inception all the way through publication. Making sure that everything flows smoothly behind the scenes is just as important as the science that will be conducted during the duration of the trial.
Regardless of a trial’s size, scope, or cost, there needs to be a system in place to ensure that all aspects of the study are taken care of. This includes having a post-trial process in place to see the study through the peer reviews.
Many trials have failed not because of issues with the science, but because of problems with trial management.
Elements of Clinical Trial Management
All clinical trials should have an action plan or protocol outlining how they should be conducted. Protocols should not only be detailed, but also be compliant with applicable regulations. In addition to being detailed, protocols should be straightforward and easy to understand.
Every single aspect of a clinical trial should be actively managed to ensure its success. Conduct is extremely important not only to ensure that participants feel comfortable, but to guarantee that everything is done right.
To manage all these is the duty of a trial manager, who should be appointed and should ideally be present from the very beginning. Doing so ensures they can make valuable contributions during the duration of the trial.
Helping out a trial manager is a team whose make up will be decided depending on the needs of the study. A trial team can include data clerks, administrative staff, and a data manager. Each of their roles should also be clearly defined to ensure every aspect of the trial is well managed.
The five basic process stages in project management apply to clinical trial management:
- monitoring and controlling
- analysis and reporting
A project plan for a clinical trial should provide detailed information for developing and monitoring every single aspect, from initiation all the way to analysis and reporting.
Clinical trials also work best when other groups are involved. Forming a collaborative network ensures that all the right parties are involved and consulted with in every aspect of a study.
Communication is also key to a trial’s success. Regular feedback is necessary to see the progress being made, solve any potential setbacks, and even resolve conflicts.
Effective clinical trial management is essential to the success of a study. The life-cycle of a clinical trial and its goals must be understood fully in order to develop a plan to ensure a high success rate.
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