What do you enjoy about working at Covance?
I love being part of a global organization; being able to think about ideas and solutions that must work not just for where I am but also for Rio or China or in any country in the world. I like that we work in a demanding environment, and I find the organization here offers a creative environment. It has allowed me to consider not only what do we need to do today, but what we must do tomorrow and the evolving needs of our clients and our business.
I can honestly say my role has always been interesting. There is variability in health care when we’re dealing with patients, their lives and their response to drugs in development. We need to be agile, and comfortable in the knowledge that what we’re doing today, to the best of our ability, may only be good until tomorrow. You don’t want to change for change’s sake, but you do want to be able to evolve and do so relatively quickly. I find Covance has allowed me to do that, which has kept me challenged, engaged and motivated over time.
How do you think the industry has changed from when you first started out twenty years ago?
The robustness of standards, particularly standards like Good Clinical Practice (GCP) has strengthened. As an industry we’ve made significant progress and put consistent baseline standards in place that protect patient safety and data integrity. I think that’s a great positive trend for our industry.
Also, the global nature of trials and roles has changed. Twenty years ago, having a single country or handful of countries in a study was pretty common. Whereas now, a large study could include almost any country around the world with potentially thousands of patients and millions of data points.
Would you say that the change is a change for the better, in terms of how the industry has evolved over the last twenty years?
In many ways, yes. The focus on patient safety and data integrity is obviously important for us and has evolved on a global basis. Studies are more complex now. In many cases, we have double the number of inclusion/exclusion criteria and double the number of end points. We’re collecting more data and yet we are still trying to answer the same questions – Does this drug work? Is it safe to take in a large scale population? Is it efficacious? Does it deliver value?
What advice would you give to someone starting out in their clinical research career?
This industry is a fabulous place. I encourage people entering the industry to keep an open mind and to be broad and be flexible, particularly at the start of their careers. Focus on gaining exposure to as many aspects of the industry as possible, as you just don’t know which area will resonate most with you.
Remain open as you progress in your career and consider making lateral moves, as well as upwards moves in your career ladder. Gain exposure and experience. Everything is so much bigger now; our companies are bigger, our projects are bigger and we have much more specialization. It’s sometimes easy for people to grow their careers in a very narrowly focussed manner; however, when it comes to getting to the senior leadership level, I think having broad exposure to different areas is critical in a highly interconnected healthcare ecosystem.
What do you think the industry should be doing to attract and train CRA’s and project managers?
This is an amazing industry to be part of, but you can become too narrowly focused in a specific area. As an industry, we should be investing in training programs that focus on competency development and looking at rotational assignments so people can be exposed to other functions, different thinking and problem solving.
The focus of many of the roles in this industry is risk mitigation — anticipating, identifying and helping prevent potential problems – be it monitoring data or spotting potential patient safety issues at a site. Still, we don’t want CRAs to just check off a list to say “yes” these things have been done. We need them to be an important part of the process that helps protect patients and safeguard the integrity of the data. Be curious about looking under the covers and thinking about the environment in which the patient has been treated and the environment in which their data have been collected. I would love to see us – at an industry level – positioning those competencies of critical thinking and problem solving against key roles. The people who I see in those roles who do it best, are the people who are curious, ask questions and interrogate their roles and their day-to-day activity.
How is Covance addressing this industry wide issue for these roles?
At Covance we’re looking at it from a number of different ways from a CRA perspective. We’ve launched a monitoring academy where we’ve identified the competencies we value in our CRAs and determined how we can bring people in who start from the right baseline, meaning they can be deployed very effectively. This, combined with a certification program, means we’re investing in training the right individuals. Last year (2016), more than 350 people participated in the program, and they are proving to be some our key talent who perform their jobs effectively. For us, it’s been a huge success.
Do you think there’s going to be move away from length of service?
Yes, there will be a shift toward competency-based measures. If people have the right competencies and skills to do the role effectively, that’s what matters. For example, just because a person has been in a role for five years doesn’t necessarily make the person effective. Someone with far less experience who undertakes intensive training and is educated on all the key issues could be much more effective, with far less experience. I’d like to see the industry recognize a competency basis and a proficiency basis as opposed to just years of experience.
How do you think IAOCR are helping to address the talent crisis?
I think having a central focus on talent is critical and a central body that helps advance the whole industry is important. Raising global, visible standards is key; setting targets for competencies and standards is very important. I think it’s then up to the individual company to apply the competencies and standards.
I also think there’s a huge value to having a central group which can help us promote careers in this industry. The clinical research industry in general doesn’t always get much press coverage, so it is maybe not on the radar for many university students as they plan their careers. What can we do to attract more people into this industry? We need to raise awareness that there’s not just opportunities for science graduates. We need people with backgrounds in statistics, human resources, operations and people management. There are rewarding roles for many different types of people within our industry, but I’m not sure we promote our industry as well as we could or should.
What do you think the top three challenges are for our industry in the next few years as you would see it?
Simply put, I think about the challenges as the three P’s: people, patients and policies.
Finding talented staff, particularly those people who are able to make the transition as we evolve our risk-modulated approaches. Those who can think critically and evaluate an environment as opposed to relying on a standard checklist or a standard operating manual. We’re evolving our understanding of what should be standardized and automated and what needs a higher-order level of thinking. So we need people who have a deep, holistic understanding of their roles. Ultimately, that will be more rewarding and will help us attract the most talented people.
Secondly, I think finding the number of eligible patients required to conduct future clinical trials will remain challenging. We are seeing significant increases in the number of patients being entered into trials and the demand and competition for those patients is high. We have to look further, broader and wider geographically, using sophisticated analytics, to find them. As we look at more sites per study, we need those sites to have the requisite competencies, experience and ability to look after the patients in the context of a trial.
Finally, we are in a rapidly changing and evolving environment, with new policy frameworks, such as the 21st Century Cures Act and new regulatory standards, such as the launch of ICH E6 and the E.U. Clinical Trial Regulation. As we mature the implementation of Risk-Based Monitoring, realise true value from big data, deploy m-health options and reach out to patients in novel ways, it is critical that our industry and each one of us in it, consider how to engage effectively. It’s a remarkable time to be part of this exciting industry, and we have an opportunity to take an active part in evolving the drug development paradigm so that more patients can benefit from effective, safe treatments in the future.