Well, maybe, not so secret. Successful management of all elements of the Trial process will substantially improve the outcomes of clinical trials.
If all aspects of a trial are not carefully managed, a trial can very quickly spiral into the abyss of nothingness.
So, let’s take a look at the ingredients that make up a successful trial.
1. A Dedicated Trial Manger
A common mistake that is made is that a dedicated Manager is not nominated at the start of a trial. The Manager is brought in after the framing of the design of the trial…by then, very often, the horse has already bolted.
A common reason for this is financial constraints. However, trying to scrimp on the investment in a Dedicated Trial Manager is a false economy. A good trial manager will not only provide insightful and knowledgeable input and commentary in the design phase, but can often help in the budget allocation process.
A trial manager should essentially have excellent project management skills. The ability to plan, coordinate and a dedicated approach to timeliness are “must haves”.
In addition, a successful trial manger will almost always be a “people person” with the ability to motivate and harness the capabilities of, often times, individuals with different temperaments and varying skill sets.
2. Project Planning
That old adage – If you fail to plan, you are planning to fail, never rang truer than in the world of Clinical trials. A properly conceived project plan which includes a PDCA (Plan Do Check Act) approach is invaluable.
Beyond just timelines, a project plan should have the following elements:
- Clear, unambiguous Objective(s): What are we trying to achieve? Is there a distinct outcome that we are looking for?
- Timelines: Length of the study/protocol? Duration of projected “study startup”? Due dates for items such as IEC reviews, enrollment activities, etc.?
- Defined Resources: Personnel and resources required…do you have everything you need for a successful trial?
- Accountability: Who will be accountable for which tasks? A clear matrix outlining tasks and accountabilities is a must.
- Communication flows: What, who, when and how? What will need to be communicated to the team, who will communicate? When and how will communication take place?
- Risk Management: How will risks be mitigated? What might these risks be? A Risk management approach to project management is a must for a successful trial.
3. Willingness to negotiate and prioritize project elements
Negotiation and prioritization in a complex Clinical Trial Project will ultimately lead to a successful trial. With the pull-push nature of the three main elements – budget, time and quality, a successful team will be able to traverse the project constraints upfront and negotiate project priorities at the very outset.
These upfront deliberations also provide the project manager of the Trial to adapt to unanticipated variations throughout the project lifecycle. To cite an example, based on discussions in the planning stages, the project manager may allocate a contingency amount of the budget to for any clinical trial protocol adjustments that may occur.
4. Holistic approach to Systems
All aspects of a trial must be carefully logged and stored. But, this in itself is not enough. The system in use must allow for the creation, or at the very least integration of Gantt charts (project timelines), daily monitoring, centralized data storage and access capabilities; reporting and any other trial-specific requirements.
There are a host of Clinical Trial Management Systems available. The trick is to ensure you use the one that is fit-for-purpose.
5. Effective Communication
Communication is of paramount importance to a successful Trial.
The establishment of clear communication channels and guidelines at the very outset of the trial will ensure that team members and participants are engaged in the process. It also ensures that any issues are dealt with in a timely manner.
All communications should be documented. This is best practice. Even a short meeting or verbal instruction should be documented (minutes of a meeting, email confirming a discussion etc.) This makes a review process much easier and simpler.
To summarise succinctly, the success of a clinical trial is dependent on strong and effective Leadership, robust Planning, the willingness and ability to Negotiate Priorities vis-à-vis known resource constraints, the use of appropriate Systems and Technology; and, clear Communication.
Nothing is ever guaranteed with Clinical Trials, but, if you follow the above basic tenets, then, there is a greater likelihood of success!!
