Through a project plan, your increase the chances of your trial being successful by lightyears. On top, you should make sure to have a Project Manager who makes sure that the plan is implemented accordingly.
There are certain activities that benefit your planning process, and others that don’t add any value to the trial planning process.
Set clear goals and outcomes: This can relate to the recruitment process in terms of timeline and cost; it can relate to the retention rate; or even to the IRB approval process.
Set a budget: Staying in budget is important. Think carefully how much you need to meet your desired goals and outcomes.
Allocate Resources: Who is responsible for what? Which part of the protocol gets how much from the budget? What resources do you need to complete the protocol timely?
Risk Assessment: Think carefully about the risk associated to the protocol! Like this, you will be prepared for any event.
Not monitoring your goals, outcomes and budget: You set all the desired goals and outcomes, and also your budget. Great! But, why are you not monitoring them in the process of your trial? This uncovers gaps through which you can reassess your plan. If you unveil these gaps early enough, it probably helps to reduce problems later on. And, you should definitely follow where the budget is going! Like this, you can make sure than cash is going where it should be.
Not executing on your goals, outcomes and budget: It is important that you execute on your plan! Without a proper execution, it doesn’t make sense that you set your goals, outcomes and budget in the first place.
Not communicating properly: Specifically when working with a larger team, communication is everything! Your trial, be it planned extremely well, can fail because of bad communication! Make sure you communicate properly who is responsible for what; how you want to execute on your plan to reach goals and outcomes and stay in budget; and who reports to whom.
Not setting timelines: Make sure that you set deadlines for every single milestone. For example, IRB approval, complete enrollment, first trial report etc. Make sure that you communicate these deadlines properly and use a proper monitoring system to stay ahead of your deadlines.
Do you need help with planning your clinical trial and / or patient recruitment? CitrusLabs can help! Contact us now.