An experienced clinical psychologist, Doug Peddicord – Executive Director, ACRO (Association of Clinical Research Organizations), entered the clinical research industry following a year as a health policy fellow for the US congress. During the inception of ACRO, as a non-clinical researcher, Doug’s in-clinic insights, combined with health policy and lobbying expertise have led the trade organization since it was formed.
What interested you about clinical research that made you decide to make the move from clinical psychology?
I thoroughly enjoyed helping patients as a clinical psychologist, it was very fulfilling. As a healthcare provider, I’d also had an involvement to an extent with clinical research, but I only had a high-level understanding. In parallel, my interest in broader health policy issues continued to grow which is why I jumped at the opportunity to be a health policy fellow for the US congress. The timing meant that clinical research was evolving from a cottage industry into an industry with growing investment and a new commitment to professionalization and globalization. These two things were exciting so when I was given the chance to lead ACRO as the executive director, I was very happy to take it.
What do you enjoy most about working at ACRO?
ACRO was formed by the directors of leading organizations who are, in many ways, the founders of the clinical research industry itself. Working with these top executives of the organizations is a real privilege. I get to work with not only those who helped conceive the industry but also those who have helped it evolve over the past 30-35 years. These people pioneered the professionalization and globalization of clinical research.
Beyond who I work with, I enjoy the work we do. ACRO is organized into a series of committees such as global data protection, ethics and regulatory, compliance, and scientific and regulatory to name a few. Working with senior level executives from our member companies we use their wealth of experience to address these industry issues for the future. This is exciting work.
What is the most challenging part of your role at ACRO?
There are lots of challenges. At ACRO we are very much an advocacy organization. We advocate with our regulators – the FDA, EMA and others; we also advocate legislators such as US congress, the European Commission with the goal of fostering a regulatory and business environment worldwide that allows our members to pursue excellence worldwide. That’s a lot of work to be done. We are only a small staff so we’re certainly challenged all the time to reach our goals.
We are striving to ensure that there is a regulatory and business climate that allows our members to prosper whilst bringing efficiency and speed to clinical research. In an intensely complicated and detailed orientated profession, identifying and introducing efficiencies to the research process is complicated but it will have huge benefits for everyone, not least the patients.
Working with a lot of top executives, do you encounter many differing opinions when trying to agree the way forward?
Our member companies, in terms of business are fiercely competitive with one another – constantly competing for contracts, talent and beyond. However, in the context of the trade organization the members of the ACRO board are very collegial and focused on the clinical research industry. In the higher context, they all support advancing the industry broadly. They work to bring efficiencies to the marketplace via competition but they are also dedicated to cooperating and collaborating on policy frameworks that will advance all the stakeholders and all the people who work for CROs.
How do you identify what to focus on as an organization?
Across our committees, we work on a wide variety of issues and opportunities; but we’re always led by the industry itself. ACRO has recently been exploring the question of the quality and competence of the clinical research workforce which includes coordinators, monitors, project managers, amongst others; there are a great many people across a lot of disciplines. Given the professionalization of project management to the industry as a whole. We are looking at supporting various initiatives because we think this question of the quality of the clinical research workforce is central both to our excellence but to the excellence of the research industry overall, and certainly to the patients who are the stakeholders and beneficiaries.
What is the most rewarding part of your role at ACRO?
Over the 16 years, CROs are increasingly a source of not only experience but enormous expertise in clinical research. To think that 15 years ago, they were the arms and legs for clinical research projects, whereas now, beyond that they are increasingly involved in research and innovative trials design. CROs are increasingly seen as strategic partners.
The CRO workforce has grown significantly because of the changes in the world we operate in – pharmaceutical companies, for example, have cut back on the research workforce and are increasing outsourcing the clinical developments. This has been particularly rewarding because in many ways we’ve gone from telling people who we are and that we deserve a place, to having people understand that we are increasingly central to clinical research.
Do you think some of the changes have had a negative impact on the industry?
I think two of the biggest changes to the clinical research industry are globalization and the transition from a purely academic background. The globalization of the industry has an impact in so many ways, not least from a numbers game to recruit from, but also the potential and opportunities it offers to make trials available to much more diverse populations – this is good for science and patients in non-US, non-EU countries. There are enormous benefits working in Asia-Pac and Africa for science and patients.
As I mentioned, beyond globalization, we have been instrumental in moving clinical research beyond academic institutions and tertiary care facilities. Today, in the US, trials take place in academic institutions, hospitals, rural health clinics, even in individual physicians’ offices. I think that transition has been good for science and patients.
What advice would you give to someone starting out in clinical research industry?
I’m not a clinical researcher but I’ll say there are enormous opportunities in clinical research, both in the sponsor side of the world (pharma, biotech, med device) and in the CRO side. Like much of healthcare, the future will become increasingly shaped and influenced by technology, specifically health information technology. As such, there are new opportunities utilizing the data that comes not only from clinical trials as well as the data from clinical care. Electric records, IT devices as well as wearables will all shape what the clinical trial future will look like. This will create lots of new opportunities, particularly for technologists. Previously the Industry was all about scientists and clinicians, and while they’ll remain fundamental, technologists will also be added into the equation. We need to figure out how to better capture data but also how to capture new and better data and how to use that data in combination with the data of randomized clinical trials to produce an even stronger portfolio of evidence.
Describe yourself in five words…
While I sometimes use too many words I do try to be measured and thoughtful. I aim to be a connector; connecting health policy makers to those with real expertise in clinical research because I believe the policy makers need to hear from them. I like to think of myself as generous – in recognizing the role of all stakeholders in the Research Industry enterprise. Certainly, patients are central, but all of the stakeholders (sponsors, CROs, statisticians, regulators) have a crucial role to play. Beyond that I think I would like to say I’m effective, but we’ll have to look over time.
What do you think the industry should be doing to attract, train, qualify and retain talent?
The ACRO board of directors has been looking at workforce issues for a year now. The industry on the whole has a lot of thoughts about attracting, training, qualifying and retaining talent. As business people, they recognize that when there is a shortage, or perhaps a perceived shortage, of talent that has a number of effects throughout the system. CROs have to spend more time and money recruiting and attracting people, and then retaining them. However, everyone wants superior talent to be recognized and compensated; what we’d ultimately like is to have a larger workforce.
There are those who certainly believe there is not a shortage of recruit-able people. There are lots of fields that provide good preparation for a career in clinical research, from health professionals, to statisticians to project managers – so arguably there should be plenty of recruit-able people. The question is then one of qualifying and retaining those people; which is a more complicated issue. That is the one IAOCR is taking, a leadership role in terms of trying to provide a framework that assesses how you can know your workforce is competent and up-to the task. Different member companies are addressing that issue in different ways. It’s the qualifying and retaining part that is complicated; attracting and training is a numbers game. There are a number of efforts aimed at competence and I think if there is a stronger recognition of competence then the retention should flow naturally.
What do you think will be the top 3 challenges for the industry in the next few years?
- Having made the Industry significantly more efficient than it was 20-30 years ago we now need to make further gains; because there are still inefficiencies. It is clearly true drug and treatment development takes too long and costs too much. While we have made real meaningful gains in efficiency, how do we continue that pathway and not just make small incremental gains? That is a question that regulators and stakeholders can all agree; developing a new treatment takes too long and costs too much. That is the number one challenge.
- Further challenges, smaller but meaningful will be those questions around how will we use real-world data, real-world evidence, innovative clinical trial design and how we deal with the workforce question.
- The big one is where do we find the next leap in efficiencies to be gained.