Successful clinical trials are all about management. If you aren’t able to manage each and every aspect of the trial, the clinical trial is unlikely to succeed. A successful trial is also an outcome of plenty of factors falling into place. It needs the right participants, the perfect trial team, and the right trial manager; all these factors need to come together for a more cohesive trial.
So, let’s take a close hard look at 5 mission critical factors that ensure a trial is conducted successfully and delivers the results you are looking for.
1. A Dedicated Trial Manger
A clinical trial needs a dedicated trial manager, not somebody who works on different projects at the same time. Sometimes the people in charge make a cardinal error. They bring the manager on board much after the trial has been designed; one reason for this is funding constraints. But a good trial manager will not only provide valuable inputs during the trial design phases but will also put in his/her two cents as far as the funding is concerned.
A trial manager should have the ability to plan, coordinate a project and ensure it is completed within the pre-designated deadline. Something else the manager must have is good motivational and organizational skills. This is crucial because even the most results oriented trials have their downs. It is when the project is not delivering the expected results or facing problems like funding issues that managers need to come into their own to motivate the team to stick to the action plan, no matter what. Successful trial managers also have a deeply ingrained sense of leadership and have the knack to innovate as they go along. What’s even more important is they have the strategic and tactical sense to keep the project within the precincts of the budget and ensure that it’s executed the way it is supposed to be executed.
2. Comprehensive Project Planning
You can’t have a successful clinical trial without sound project planning. It’s important to think of a clinical trial as a project and planning it using the best tenets of project management. In fact, a clinical trial manager does a lot of things that project manager does and more. So, a typical plan for a clinical trial should include.
- Working out the modalities of the objectives and change that the trial’s objectives will usher.
- Hiring the right team, where the right people are given the right responsibilities.
- Setting a timeline for the clinical trial and its various stages.
- Identifying, defining and assigning trial resources.
- Preparing a list of tasks, aligning them with pre-specified standards and working out how they need to be completed.
An effective project management plan needs to chart out the life cycle of a clinical trial and put in place the various processes needed to develop and monitor the various aspects of the trial. A trial is a collection of various activities that are working towards an objective. Some of these activities include data management, data evaluation, reporting, analysis etc. Proper project planning ensures all these activities having abearing on the clinical trial are conducted with precision.
3. Spirit of Collaboration
A clinical trial is a collaborative effort, and this not only includes the team but also the participants. Clinicians, nurses, project managers and administrators, all need to collaborate effectively on the trial to ensure success. Inclusivity is the mark of all successful projects, and the job of the trial manager is to ensure that certain groups are created within the project to ensure better collaboration. The collaborative spirit can only be fostered if the various people who’re a part of the project feel they own the project. This can only happen if the various project stakeholders are involved in every step the project takes and the concerned people are consulted at every stage. Interpersonal relationships play a significant role in effective project collaboration. The people in charge of the project must do everything necessary to ensure people who are a part of the project understand one another and don’t step on each other’s shoes. The idea is to allow a person to work without inhibitions, which in turn ensures the trial is completed successfully.
4. Effective Communication
You can call communication the centerpiece of a collaborative environment. The whole purpose of a clinical trial is to find answers for a specific clinical question. This means investigators who’re a part of the project need to talk to each other and as mentioned before must feel involved with the project. This is only possible if effective channels of communication have been integrated with the project right from the design stage. The clinical trial must have a communication strategy in place to effectively track the project progress. What communication also involves is getting regular feedback from the various investigators who are working on the different aspects of the project at the same time. Effective methods of communication like telephone, emails and personal contact must be identified and institutionalized. Proper communication ensures problems are identified and the various issues that are a part and parcel of every clinical trial are resolved quickly.
5. Robust Systems
A trial, its participants and all its aspects need to be monitored on a day to day basis to make sure the trial is on track. This is only possible with the implementation of reliable computerized systems whose job is to monitor activities like participant recruitment, data management, central data monitoring, randomization procedures and others to make sure the necessary reporting takes place at the right time in the right manner.
If you are able to manage the trial effectively, you will get your hands on high quality data. As can be imagined, getting access to high quality data is not easy as it needs to be sensible, reliable and reflect the true situation of the trial. This is complicated and requires a fair amount of detailing. Therefore, the system that you choose needs to be able to validate data through strict quality control and must also be scalable to keep up with the growing demands of the clinical trial. It’s of paramount importance that the computer system be developed keeping in the mind the specific requirements of the clinical trial. The trial and its data requirements must not be made to fit into an existing computer system. This defeats the purpose of having a system in place altogether.
The Objective is to simplify a Complicated Process
All clinical trials are complex and their effective management is not easy. But, it is simplified if you are able to get the various factors that ensure successful clinical trials, right. A trial needs to follow all due processes and this is only possible if the right factors are added to the clinical trial mix.
