Jonathan Seltzer, MD, MBA, MA

This article originally appeared as a peer-reviewed article in the June 2014 issue of ACRP's Clinical Researcher. 

http://www.acrpnet.org/MainMenuCategory/Resources/Clinical-Researcher.aspx

Medicines development and clinical research are among the most heavily regulated activities on a global basis.  As our understanding of pathophysiology and therapeutic intervention has increased, there has been a concomitant increase in the complexity of clinical trial protocol requirements

 and in the number and complexity of the regulations and guidelines related to the preclinical and clinical testing of new drugs and devices.

  Quite curiously, though, there are only very general requirements ad scant detail in the regulatory authority definitions of the criteria required of individuals who are responsible for the conduct of human clinical trials.  Previous versions of the Declaration of Helsinki

 list only vague requirements for education and experience.  In most countries, anyone with a medical license can serve as a principal investigator of a clinical trial, regardless of whether or not he/she has had previous training or experience in clinical research.  For physician investigators, clinical research coordinators (CRCs) and clinical research associates (CRAs), there are certification programs which are highly regarded, but there are no formal regulations which define the educational or experiential requirements and personnel certification is not mandated.  The tide is beginning to turn; however, the latest version of the Declaration of Helsinki, dated October, 2013, now states that “medical research must be conducted by individuals with appropriate training and qualifications in clinical research.”

 India is moving towards mandating certification for clinical investigators, but it I uncertain what competencies such certification will require.  Many professional organizations have developed training programs for individuals who conduct clinical trials and some clinical institutions require clinical research training as a prerequisite for participation on the research team.

 During the last decade, academic institutions have developed programs which award advanced degrees in clinical research, clinical trial management and regulatory affairs.

 Although one can infer that education and training will enhance the level of regulatory compliance, we have been unable to translate this into a measurement of competence. This is perhaps because there is no systematic harmonization of job descriptions and performance outcomes for the many roles that exist in the clinical research enterprise.  Recently, several professional groups related to the clinical research enterprise have published articles and white papers or presented content at professional meetings which have brought this message to light.

As the concept of competency based education and training has spread to the medicines development industry, many groups have produced a listing of knowledge, skills and attitudes which define the core competencies required of the clinical research professional.  For the most part, the approach of each group has been focused on a specific component of the clinical research enterprise.  Some examples are the National Center for Advancing Translational Sciences institutions in the US which have developed listings of core competencies for translational research scientists,

 the International Federation of Associations of Pharmaceutical Physicians and the Academy of Physicians in Clinical Research have developed listings of core competencies for pharmaceutical physicians and clinical investigators,

 the Consortium of Academic Programs in Clinical Research has developed core competencies for graduates of academic programs and to guide curriculum development,

 the Association of Clinical Research Professionals has defined a career development pathway for CRCs, CRAs and investigators which incorporates competency statements,

 and the Regulatory Affairs Professions Society has adopted core competency statements that relate to regulatory affairs professionals.

  Furthermore, professional nursing in the US and United Kingdom has contributed to this effort through a variety of clinical research role delineation studies and competency defining publications.

  These combined efforts have begun the process of moving the clinical research enterprise from a focus on regulatory compliance to a focus on professional competency.

In an attempt to bring together these disparate, but high quality efforts focused on clinical trial competence, a meeting of representatives from pharmaceutical companies, contract research organizations, academic institutions, clinical research sites and professional societies was hosted by the Multi-Regional Clinical Trial Center at Harvard University during spring, 2013. A broad based and widely representative group was formed and named the Joint Task Force for Clinical Trial Competency (JTF).  The members of the JTF agreed to work toward aligning and harmonizing the many more focused statements relating to core competency for clinical research professionals into a single, high-level set of standards which could be adopted globally and serve as a framework for defining professional competency throughout the clinical research enterprise.  The JTF had a second face to face meeting in June, 2013, which included participants from an even broader representation of the clinical research community.  A listing of the collaborating organizations is found in Figure 1.  The JTF then worked through the summer of 2013 and presented its final report in October, 2013.

The process used by the JTF was designed to acknowledge and incorporate the inputs from the many participating organizations.  It required reviewing the many competency statements and identifying Competency Domains, or broad categories of knowledge, skills and attitudes which are necessary to function within the field of clinical research.  It was determined that all of the competency statements could be aligned within eight Competency Domains which are listed in Figure 2.

The next step required assigning the individual statements of knowledge, skill and attitude (KSA) learning objectives from each of the many publications and presentations and aligning them within the appropriate Competency Domain.  The final step involved reviewing all of the KSA learning objective statements within each Competency Domain and harmonizing them so the wording of the final KSA statements were inclusive and represented each individual organization’s priorities, but were not redundant or repetitive.  It was decided that the harmonized competency statements at this level should reflect primarily the cognitive skills and that the performance or attitudinal aspects of learning objectives were best defined at a more granular level by groups which would be using these harmonized competency statements as a framework to further develop the focused expressions for specific components of the enterprise (e.g. job descriptions, accreditation criteria, training requirements).  The JTF and collaborating organizations were then given the opportunity to systematically review the proposed competencies and domains.  Comments and suggestions were integrated into the final product which is presented in Table 1.

Moving Toward the Future:  Implementation of the Harmonized Core Competency Framework

The Core Competency Framework can be used in many ways toward improving the quality and safety of the clinical research enterprise; for example, to define certification criteria used by personnel or site certifying agencies.  The Core Competency Framework could be used to formulate accreditation standards for academic programs to both standardize curricula and to ensure that programs are sufficiently comprehensive.  Ultimately though, the most effective method to improve clinical trials would be to ensure that those responsible for the various aspects of the clinical trial bring the 

 time.  The greater challenge is implementation of this conceptual framework into an operational model.  A good place to start could be the clinical research design, whereby a look at competencies across two different types of studies can reveal variability in requirements.  For instance, when an investigator-initiated observational trial is compared to an industry sponsored pre-market interventional clinical trial; it is possible to illustrate how this framework might be used to qualify a principal investigator.  As illustrated in Table 2, the competencies for the Study and Site Management Domain are identical, but not so for the Scientific and Research Design Domain.  

This does not imply that a less competent trialist can perform an observational study, but that a lower level of competency is required for that study method.  Furthermore, the level of competency might be quite different for other clinical research team roles, such as CRC, CRA, data manager or regulatory affairs coordinator.  Once the necessary competency is defined, then it is up to the principal investigator, study sponsor and interested regulatory authority to ensure that the study team member possesses the necessary competencies to carry out the selected protocol defined tasks.  If additional knowledge or skills are needed, this would be the proper place to integrate with training programs that have training materials and processes which are harmonized to the protocol specific competency requirements.

As a second example, Table 3 illustrates how one could utilize the Core Competency Framework to define the Good Clinical Practice knowledge requirements for an interventional clinical trial based on the functional roles of a principal investigator, CRC or a CRA.

The mission of this JTF initiative has been to bridge the gap between “what to do” and “how to do it”.  For the first time, a universally applicable, globally relevant framework exists which identifies the Competency Domains and the associated cognitive skills necessary to conduct a high quality, ethical and safe clinical trial.  It is obvious that all members of the clinical research team do not require the highest level competency in all of the areas listed, but these harmonized core competencies can provide a basis for development of more specific statements of knowledge, skills and attitudes required by clinical research professionals in more focused environments.  The leveling of competencies from novice to expert, or by professional role can be a next step in this endeavor.  Competency-based curricula or job descriptions can lead to standardization and elimination of redundancy in training requirements, standardization and accreditation of educational programs, better definition of career tracks and performance evaluations.  Table 4 lists several of the possible uses and outcomes which can result from the adoption and utilization of the Harmonized Core Competency Framework by the clinical research enterprise and global regulatory authorities.

It is the desire of the JTF to approach the regulatory bodies of the world for recognition and acknowledgment of the Core Competency Framework and to ultimately house the document and its future evolutions within the International Conference on Harmonization as a guideline similar to the E6 Guideline for Good Clinical Practice.

The authors would like to acknowledge Jason Nyrop (Deloitte, Inc.), for his expertise in production of the graphics and tables included; Norman Goldfarb (MAGI. Inc.), Jim Thomasell (ACRP), and Jennifer Webb (DIA) for their support in facilitating the meetings of the JTF; and Jacquelyn Murphy of the Harvard University Multi-regional Clinical Trials Initiative for her administrative support.

Stephen A. Sonstein, PhD; Eastern Michigan University, Ypsilanti, MI 48197, 

Jonathan Seltzer, MD, MBA, MA, FACC, ACI Clinical, 

Carolynn Thomas Jones, DNP, MSPH, RN; University of Alabama at Birmingham, Birmingham, AL 35294  

Honorio Silva, MD, Alliance for Clinical Research Excellence and Safety (ACRES), 

Esther Daemen, MBA, RN, Association of Clinical Research Professionals, 

Getz, KA. Assessing the downstream impact of protocol design complexity. 

http://www.touchbriefings.com/pdf/3322/kenneth-a-getz.pdf

Getz KA. Drowning is  sea of regulatory compliance.  

http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=401621

World Medical Association. Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. 2013. 

http://www.wma.net/en/30publications/10policies/b3/

International Conference on Harmonization.  ICH Tripartite Guideline: Guideline for Good Clinical Practice E6(R1).1996.  

http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1_Guideine.pdf.Accessed January 9

Speicher, LA, Fromell G, Avery S, Brassil D, Carson L, Stevens E, Toms M. The critical need for academic health centers to assess the training, support and career development of clinical research coordinators:  Recommendations from the clinical and translational science award research coordinator taskforce. 

Carter, SC, Jones CT, Jester PM.  Issues in clinical research manager education and training.  

Jones, CT, Browning, S, Gladson, B. Defining competencies in clinical research:  Issues in clinical research education and training.  

Sonstein, SA.  Core Competencies for entry-level positions in clinical research.  44th Annual Meeting of the Drug Information Association; June 22-26,2008, 2008, Boston, MA.  

Sonstein, SA, Silva H, Jones CT. Harmonization of core competencies across the clinical research enterprise to help enhance the quality of clinical trials and the personnel who conduct them. 48th Annual Meeting of the Drug Information Association; 2012; Philadelphia, PA.  

Silva H. Challenges to clinical research in the USA and Latin America. 2009. Pan American Conference on Medical Education. Buenos Aires, October 9-13.  

Clinical and Translational Science Awards.  Core competencies for clinical and translational research. 2011; 

https://wwww.ctsacentral.org/education_and_career_development/core_competencies-clinical-and-translational-research

Silva H, Stonier P, Buhler F, Deslypere J-P, Criscuolo D, Nell G, Massud J, Kesselring G, van Olden R, and Dubois D. Core Competencies for pharmaceutical physicians and drug development scientists.  Frontiers in Pharmacology. 2013;4(105):1-7. 

Koren M, Koski G, Reed DP, Rheistein PH, Silva H, Stonier P, and Seltzer J. APPI Physician Investigator Competencies Statement.  

Association of Clinical Research Professionals.  Find Your Pathway.2013; 

http://www.acrpet.org/MainMenueCategory/Education/Find-Your-Pathway.aspx

Regulatory Affairs Professionals Society.  Regulatory Affairs Professional Development Framework:  An Overview.  White Paper. 2013. 

http://www.raps.org/portals/0/documents/pdf_framework_whitepaper.pdf

Bevans M, Hastings C, Wehrlen L, Cusack G, Matlock, AM, Miller-Davis C, Tondreau L, Walsh D. and Wallen GR. Defining clinical research nurse practice:  results of a role delineation study.  

Castro K, Bevans M, Miller-Davis C, Cusack G, Loscalzo F, Matlock A, and Hastings C. Validating the clinical research nursing domain of practice.  Oncol Nus Forum; 2011;33(2):E72-80. 

Ehrenberger H, Lillington L. Development of a measure to delineate the clinical trials nursing role.  Onc Nurs Forum. 2004;31(3):E64-68. 

Competency Framework Working Group.  Competency Framework for clinical research nurses:  A tool to promote patient safety and quality data.  2nd ed: Competency Framework Working Group; 2011:  

http://www.rcn.org.uk/_data/assets/pdf_file/0019/201466/Research_Nurse_Comptency_Framework-Version 2-Full-Oct_2011.pdf

Hastings C, Fisher CA, McCabe MA. The National Clinical Research Nursing Consortium.  Clinical Research Nursing:  A Critical resource in the national research enterprise

Articles

Medicines development and clinical research are among the most heavily regulated activities on a global basis.

Jonathan Seltzer, MD, MBA, MA

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Moving From Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research Professional