Making a simple project plan can increase the chances of success for any clinical research tenfold. Under the guidance of an experienced project manager and equipped with a fully-costed feasibility analysis, a detailed plan should provide the basis for clinical protocol - and, if done well, should act as evidence when dealing with clinical trial sponsors and/or patient recruitment companies. With around 86% of clinical trials failing to meet patient recruitment targets every year, it is essential that research sites continue to remind themselves of both the do’s and don’ts of trial planning.
Check out our brief checklist below for a quick reminder of the essentials to clinical trial planning. Want to know more of our top tips and tricks to running successful clinical research? Take a look at some of the articles in our archives for information.
DO'S
Set clear goals and outcomes:
This relates to patient recruitment in terms of timeline, cost, retention rates, or even to the IRB approval process. Record and keep track of your KPIs in order to be completely clear on your trial’s aims and objectives.
Set a budget:
Staying on top of your finances is important. Think carefully how much you need to meet your desired goals and outcomes; but don’t be disparaged by high-cost opportunities as these could provide safe long-term solutions.
Allocate Resources:
This starts with our feasibility analysis, as mentioned above. Ask yourself the following: who is responsible for what?; which part of the procedure gets how much from the budget?; what resources do you need to complete the protocol in time?
Risk Assess:
Think carefully about the risk associated with the clinical protocol! For a fuller guide to risk assessment and risk management, try our previous article found here.
DON'T
Cement your goals, outcomes and budget:
While it is essential to establish aims that, as we have said, are primary to a successful trial budget and project plan, it is too easy for research sites to rely solely on the numbers they figured out before even starting their clinical research. As a wise man once said ‘the world is nothing but change’ and, if we know anything about medical research, it’s that it functions on near-constant change. We recommend conducting a monthly audit in order to keep on top of your project’s progress.
Communicate poorly:
Specifically when working with a larger team, communication is everything! Your trial, be it planned extremely well, can fail because of a simple misunderstanding. Make sure your teams and sub-teams understand who is responsible for what and how you want to execute your plan; and who reports to whom.
Ignore time constraints:
Make sure that you set deadlines for every single milestone; IRB approval, the completion of enrollment, the submission of the first trial report etc. Make sure that you communicate these deadlines properly to research site staff, clinical trial sponsors, and/or patient recruitment companies, using a proper monitoring system to stay ahead of those set deadlines. We took a look at some of the best automated assistants for clinical trial recruitment today that could be very useful for managing time constraints.
Here at Citruslabs, we've developed the ideal patient recruitment dashboard to help any researcher improve their current metrics. With over 3 million patients on record, we ensure researchers are connected to a thoroughly educated and engaged pool of participants; so, it is no wonder why we have such high patient confidence! Linked directly with our #1 health app in 17 countries, Mindmate, our patient-recruitment dashboard provides researchers access to our patient database via an easy-to-use interface that is guaranteed to streamline any clinical trial.