Running drug trials is a challenge for any company. These challenges are even greater for a small company. Tracking tools can be of enormous assistance, particularly supply chain management tools, but everything in the project flows from the design, and then the execution.
A small company by definition will not have the in-house resources to run a clinical trial without outside help. There are instances of small companies with only a handful of people managing successful trials, but such companies need to hire and manage their vendors and consultants with care, while supporting those teams closely.
Companies with a total employment of only four people have done this successfully. It is more common for a small company to have 20 or more people to successfully manage even a modest trial, and not unusual for a smaller company to have 100 people, even for a single drug candidate, or perhaps for a small pipeline of two or three assets. But even if your company has 10,000 employees and can run complex trials, study design and careful management remain essential. Smaller companies just have to do more of the work using vendors.
Looking first at management tiers, at the heart of the project, the sponsor needs to have someone with deep domain knowledge. This can be someone you work with only periodically, but their input is critical at the design stage and remains critical during project management. A good consultant can help set up a project, and can help you hire the many component groups you actually need to run the trial. That consultant can check in, even relatively rarely, to be sure the groups are staying on track. Nevertheless, it is foolish to run a trial without having a primary consultant who has the experience to see whether or not a project is on track, and what pieces may need a little more attention. What might seem like a small problem may be a small problem, or it may need to be managed closely so as to not become an unmanageable problem or something that may require costly rework.
An experienced consultant might be able to do this with only tens of hours of direct involvement, but hundreds of hours or more would not be surprising. For instance, an experienced consultant may be leading or guiding a team at a major CRO. The consultant works with the sponsor to be sure the project is well specified, and then hands this to a CRO team to write the detailed specification so that the key consultant needs only to check over the detailed work of others. Similarly for site selection, and then trial management, an experienced consultant can leverage her experience to see that good teams are chosen and that they are well managed.
Looking to the next tiers of vendors and management, the small sponsor will seek thissame high level of experience and success for each of the trial component tasks:
- Site selection and management
- Data management
- Central labs
- Medical supervision
- Clinical operations
- Trial supply
- Lastly, don’t forget QA teams, at all levels
Ultimately, it is critical to engage someone at each tier with experience to design and have all of the critical pieces done in a timely and competent manner. This is vital in ensuring the trial submission will have no execution or reporting flaws that will cause the reviewers to reject it. This always involves a team, so your central coordinator also needs to be a good manager.
The sponsor company management, ultimately the Board or Shareholders, need to understand that a drug trial is very complex even for a small study, and that starving the budget can easily cause the trial to fail, or drag on at a much greater expense.
Thus it is the responsibility of the trial manager to scope the project carefully. There is always room for efficiency in trial management – pick good people, give them good tools, manage them thoughtfully. Many trials do come in on time and within budget. Look for managers who have run such trials, and look to the tools they needed and the teams they organized. A great many trials do not come in on time or in budget. These problems may or may not lie with the management, but definitely be careful when engaging with teams that do not at least mostly deliver on time.
An experienced company leader or consultant will know all of the moving pieces that are required. Trials are of such complexity that even such a person likely isn’t aware of all the required tasks, despite identifying the categories, and knowing the vendors or leaders who know the details. For example, in hiring and managing CRAs (or study monitors), there are HR requirements, hiring, managing, work tools, skills assessment and training, managing, IT issues, and many other aspects of employing people that in the end need to be done competently. It is enough for the senior coordinator to know that a certain category of task needs to be done, and it is enough to hire a company, or department, or a consultant who can identify and manage all the finer points in as much detail as is needed to bring in a successful study. But the leaders of that functional task need to be competent as well, and they need to be sure the study-critical work is executed in a sufficient manner. It’s crucial the results here are reported up and integrated into the entire study project.
So there is a pyramid of responsibility.The central leadership needs to be sure each trial component taskis both managed well as well as coordinated with the overall study pace and expectations so that the overall project can move as smoothly as possible.
There are numerous components of a trial that simply do not justify hiring a full time person or team.
For example, central labs are often important even for basic blood chemistries, and often for blood levels of drug or metabolites. It would be an unusual trial that required such testing eight hours a day for months on end – so this is something that gets contracted out. Immediately we see that the vendor needs to be identified, vetted, selected, and then managed. Be sure to cover all bases: are they Part 11 compliant? How will you deliversamples to them?How will you collect and control the samples before they get to the lab? While these questions may sound obvious, it’s important no stone is left unturned.
Many other tasks are important for a time, and then not. Site selection, study monitoring, drug supply tracking, depot monitoring – there are dozens of categories and hundreds of people, ultimately, that are needed at some point in the project.
A trial sponsor can reach out to vendors of varying sizes to organize these many tasks. Many large CROs can handle the project “from soup to nuts”, but the responsibility ultimately falls on the sponsor. What’s more, the sponsor needs to be sure the project is providing useful data, that the pace of enrollment stays on track, and that every one of those hundreds of tasks is being done effectively. It is quite a waste to spend millions or tens of millions of dollars on a flawed study. Even a simple thing like mismanaging the supply of trial material can throw the study out of whack. There are a multitude of quality control and data security details that can cause the study results to later be questioned, challenged, or worst of all rejected.
So in the end, it is critical for the study sponsor to have a lead employee or consultant who is experienced at the big picture of trial design and management, and to be sure that within the key reporting group there are those who understand the tiniest critical details of the trial and that these are being looked after. It is a lot of work, but it is surely a joy to complete a successful trial!