What makes a clinical trial succeed or fail? That question seems to be being answered by every article, white paper, video, and advertisement on this website, as well as on nearly every outlet across the clinical research space.
There are many things that cause a trial to fail that are, unfortunately, unavoidable: ineffective compounds, poor pre-clinical to clinical translation, safety issues, running out of money, to name just a couple. However, one area that continues to trip up sponsors and solution providers alike, and one that is entirely controllable, is the structure of the clinical trial team. This article will seek to examine some key strategies to consider when putting together a team for a clinical trial:
1. Know your onions
Delegate and assign tasks to the best people on the team. This may seem obvious but it is an area often overlooked in favour of speed of action. Allocation and delegation of tasks to either less experienced or overqualified staff can cause both research errors and reduced motivation within the team, with staff not engaging with tasks for which they feel they are ill-suited.
It is also worth mentioning here, as it leads neatly to the second point in this list, that allocation of the best suited staff is of key importance when managing that curse of the clinical trial team: loss of staff. When team members leave, as always happens, it is significantly wiser (if possible) to promote from within to fill that role, covering the now vacant position with a new hire. Existing staff moved into a more senior role are, firstly, already well versed on the nature of the trial, the protocol, and team structure and can keep disruption to a minimum. Secondly, filling any position at short notice will cost a pretty penny, and any number of recruitment providers will happily lighten your purse; recruiting a junior position will make a much smaller dent in your budget.
2. Investing in staff to the benefit of the trial
The Journal of Clinical Oncology estimates that technical staff (nurses, data managers, etc.) account for 30% of time allocated to a clinical trial, but only 9% of the budget. It seems counterproductive to skimp on staffing costs, and cutting corners by having staff cover multiple roles – it is better that one job gets full attention than two jobs are done poorly. A recent joint NIHR and UK MRC study found that studies that recruit a dedicated trial manager, responsible for only that trial, were nearly four times as likely to achieve patient recruitment targets so it certainly seems like it is worth losing a little off the bottom line, by investing in the right staff, to ensure you have a bottom line to look at.
3. Doctor knows best
Engagement with physicians, especially in a hospital based trial or study where drugs are perceived as part of wider healthcare delivery, is crucial to trial success. Doctors should have clearly defined roles in the trial process; patient recruitment, data collection, and patient adherence can all fall under the doctor’s purview and are all roles they can perform admirably. What is key is that they are clearly aware of the role they are performing (and how it fits into the wider team), and that they are fully engaged in the trial process and aims. It has been suggested, particularly in North America, that physicians see clinical research as an inconvenience and a process in which they should not have to play a role. Education of doctors, and empowerment of them within the research team, will go a long way towards trial success. One key way to do this is by allocating a dedicated physician liaison, included within the clinical operations team. This role ensures that physicians are fully engaged in the wider team, channels of communications and instruction are open, and any potential issues with physician compliance can be dealt with before they have an impact.
4. Join the dots
There is no escaping the fact that a clinical trial is a complicated and disparate beast, especially in later phases where thousands of patients are spread across multi-national sites. There is also no escaping that clinical research requires service provision from a number of different kinds of providers: laboratory services, manufacturing, packaging and labelling, data management, and logistics all need to be delivered by separate providers, and that is just a drop in a vast ocean.
There is no avoiding working with a huge number of solution providers; what can be avoided is delays, confusion, and error in bringing all these parties to sing from the same hymn sheet.
In many situations outsourcing and procurement managers have secured the services of solution providers and simply handed over contact to the clinical operations team. This creates a lack of coherence for all concerned, double handling instructions and adding time to the process. It is much more sensible to incorporate management of vendors into clinical operations functions from the start of the process, ideally having a clinical operations manager covering providers grouped either by location, or by service type. Again, arguably a higher investment required, but worth it if clinical supplies reach their location at the right temperature, or sample results come back from the lab in time.
In summary, this is by no means an exhaustive list and pulls together a range of established opinions. What it should serve to do is illustrate the following key factors in the efficient planning and running of a clinical research team:
- Recruit the right staff
- Place those staff in the right roles
- Have clear lines of communication across all aspects of the trial
- Don’t avoid spending at all costs – more money will be made on an approved drug than will be saved on one that never makes it.
Clinical trials will never be without pitfalls; you can never foresee the drug, which cured every monkey and rat it was tested in, failing as soon as it reaches human subjects. What you can do it to control the controllable, and give your trial the very best chance of success.