Ahead of Clinical Trials Day, which takes place on May 20th, Outsourcing-Pharma.com talked to Jim Kremidas, Executive Director, Association of Clinical Research Professionals (ACRP), about the history of the day, why awareness is needed, and how the industry can continue to move forward.
Melissa Fassbender, Outsourcing-Pharma.com: What is the history of Clinical Trials Day?
Jim Kremidas: Clinical Trials Day historically has been celebrated to recognize what many consider to have been the first randomized clinical trial conducted by James Lind in May 1747. But it’s equally important for us to celebrate and recognize the women and men at the grassroots level of clinical trials – clinical research professionals – and the contributions their work has made to public health and wellness.
Diseases have been eradicated. Improved quality of life has been provided to those suffering illness. And hope exists today for those who will be afflicted tomorrow. All of this is a direct result of the day-to-day work of clinical research professionals.
Fassbender: How has the event changed over the years?
Kremidas: Clinical Trials Day has evolved into a global celebration of clinical trials and those involved in their conduct, whether they are at sites, sponsors, contract research organizations, academic institutions, independent review boards, or elsewhere. ACRP’s celebration of Clinical Trials Day continues to evolve.
We are providing a platform for clinical research professionals to share their success stories and to share what inspires them to remain so dedicated to medical innovation. We are sharing the stories of volunteer patients; stories that reinforce the direct and personal impact clinical trials have on patients and their families. We are thrilled this year to also provide clinical research professionals with free educational sessions designed to support their work today and into the future.
Fassbender: Why does more awareness need to be brought to clinical trials? And how has this need changed in the past five years?
Kremidas: Awareness is critical to finding volunteer patients, without whom clinical trials would be impossible. As many as 40% of clinical trials fail to meet recruitment goals, which ultimately delays development of new therapies and treatments and their delivery to those in need. The need for volunteer patients itself has not changed, and will not change, but I fully expect to see greater emphasis within industry and government on increasing awareness of clinical trials among underrepresented populations. The U.S. Food and Drug Administration is working to increase clinical trial participation among people in racial, ethnic, and other minority groups, and has dubbed 2016 “the year of diversity in clinical trials.”
But I also think the industry as a whole can do a better job informing the public about clinical trials and the professionalism of those who conduct them. Clinical research professionals are just that: professionals. They have specialized training in Good Clinical Practice, the international ethical and quality standard for clinical trial conduct. Many have earned certification as specialists in clinical research, an achievement demonstrating an ongoing commitment to excellence, professionalism, ethical behavior and patient safety. Those who are members of professional organizations such as the ACRP commit to, and are held to, a code of ethics. They also hold themselves accountable for continuous improvement by actively developing their professional competencies. We need to make sure we as an industry do a better job shaping our image in the public eye.
Fassbender: What is some of the work ACRP is doing to promote excellence for the clinical research profession?
Kremidas: ACRP promotes excellence in clinical research by training and certifying clinical research professionals, and by being their long-term partner in career growth and development. While many initiatives are bringing forth excellent technology solutions to clinical development, ACRP is focused on standardizing and enhancing competencies of the people who ultimately conduct clinical trials at the grassroots level.
Currently, there is no standard path for becoming a clinical researcher. Most people gain knowledge on the job, and organizations utilize disparate onboarding and training programs. This creates a tremendous amount of variance in research conduct, processes, and workforce competence, which culminates in a detriment to research quality. Look no further than the persistence of common FDA inspection findings for proof that the current approach to workforce development is not working.
ACRP is playing a central role in defining and developing clinical research professional competencies through the Joint Task Force (JTF) for Clinical Trial Competency, a multi-stakeholder group seeking to align and harmonize core competencies for clinical research professionals into a single, high-level set of standards. The JTF, which includes representation from the Clinical Trials Transformation Initiative, Multi-Regional Clinical Trials Center, Pfizer, and more, has proposed eight core competency domains for clinical research professionals and is working to fine tune them. ACRP will be leading the process of advocating their industry-wide adoption.
Fassbender: The “war on talent” in the industry has been a prevailing issue. How can this be addressed?
Kremidas: There is a major shortage of clinical research associates (CRAs)/monitors in the workforce. As a result, sponsors and CROs are battling CRA turnover and substantial compensation increases. At the same time, it’s clear from our own data and continued FDA inspection findings that there is an insufficient level of knowledge, skills, and abilities in the CRA workforce.
We believe the root cause of the CRA shortage is prioritization of a 2-year experience requirement over validated competence. Competency based on tenure discourages a talented pool of potential CRAs who lack an industry-imposed, calendar-based requirement from trying to advance and fill the rising number of open positions. The current system in place to train and mentor new CRAs is demonstrably inadequate to meet a growing demand for new skills and talents.
That’s why we’re leading an initiative to identify and advocate a set of core competencies required of entry-level CRAs though a multi-stakeholder CRA Workforce Development Task Force. Many pharmaceutical companies, academic institutions, and CROs have expressed interesting with working with us on this effort.
Fassbender: Based on the current state of the industry, what changes do you expect over the next five years?
Kremidas: We anticipate a growing demand to bring new treatments and therapies to market more efficiently and more effectively. This pressure will force change across the clinical research enterprise and require greater public awareness of clinical research and its benefits, improvements in patient recruitment and greater trial participation, and improvements in clinical trial operations that cannot be addressed by technology alone.
Our vision is that clinical research is performed ethically, responsibly, and professionally everywhere in the world, and we believe this vision can only be realized through an industry-wide commitment to workforce development.