Surviving the Tide of Trials
CULLEN T. VOGELSON
Learning the ins and outs of clinical research doesnt have to be experimental.
Almost nine years ago, I was hired by a contract research organization (CRO) to serve as a Phase I/II research coordinator. I began the job knowing little about clinical research, and even less about coordinating a study. The CRO I worked for had a training program that consisted largely of introducing me to the in-house medical team, handing me a protocol, and wishing me a hearty good luck. Then, six months into the job, I was suddenly promoted to the position of clinical trials monitor. As a monitor, my training consisted of little more; in addition to being given a protocol, my supervisor joined me in conducting one research site visit. If this training seems a bit absurd, it is. For the most part, however, it is also typical of the way clinical research personnel are prepared for their jobs. (For specific guidance in monitoring trials, refer to the Clinical Trials Track department .)
Clinical researchers (i.e., investigators, coordinators, and monitors) have varied educational backgrounds. Theyre not just doctors, nurses, and pharmacists. Theyre also degreed chemists, biologists, and psychologists. Some have medical backgrounds, but just as many do not. In fact, many coordinators and monitors start their jobs without having taken any formal courses in medical ethics or medical research. Even those with medical training often lack specific knowledge of research practice. So, most researchers learn their jobs as they go. Investigators usually have little formal introduction to clinical research methodologies, and thus rely heavily on guidance from the coordinators they hire and the monitors they encounter. Unfortunately, coordinators, monitors, and physicians often have similar levels of research education and training. So it is not uncommon for those engaged in research to guide each other through the complex process and the maze of regulatory requirements.
Traditionally, some CROs and most pharmaceutical companies have provided training programs to teach the basics of drug development to their newest monitors and in-house study coordinators. These courses tend to last two to five days and only cover the most important procedures and regulatory aspects intrinsic to the research process. Intensive training is terribly expensive and, as a result, most companies provide very little. Therefore, monitors initially gain experience by traveling with experienced monitors, as finances permit. However, there is usually great pressure on supervisors to limit the number of such training trips. In-house coordinators often receive less job instruction than monitors, because it is assumed that they will have ample opportunity to ask peers for assistance as questions arise.
To be sure, the FDAs regulations governing the introduction of new medications into human subjects can readily be obtained and are easily comprehensible. But there are more issues involved in clinical research than the regulations address. For example, an investigator should know the purpose and potential impact of periodic monitoring visits, coordinators must understand how sponsoring companies will use the collected data, and monitors need instruction on how a site should be reviewed. For all involved, there are ethical, statistical, financial, and administrative aspects of clinical research that lie well outside the scope of federal rules and regulations but directly affect the health of volunteers and the quality of the research data.
To fill this educational void, several new training programs have emerged. Some of these opportunities are in medical and graduate schools. For example, it is increasingly common for medical and nursing students to be exposed to coursework involving clinical trials early in their academic careers. In addition, several graduate schools now offer M.S. degrees in research conduct. Outside of academia, monitors and coordinators also have increasing opportunities to participate in continuing education and recognized certification programs. As a whole, these training courses aim to create consistent and complete job preparation that on-the-job training sorely lacks.
Academic training for investigators
Most medical schools include opportunities for students to become involved in research trials. In many cases, coursework providing appropriate training in research ethics, study design, federal regulations, study management, and patient rights are available as optional seminars. For example, the University of Texas Medical Branch at Galveston offers several lectures that are open (for a fee) to faculty, fellows, residents, and others interested in patient-oriented research. These classes are also approved for medical school course credit (1).
In addition to traditional coursework, medical schools have active research programs that involve residents as subinvestigators. For instance, the General Clinical Research Center at Stanford Universitys School of Medicine is currently investigating almost 140 protocols, nearly all of which involve resident assistants (2). As a result, during their medical training, interested students can become familiar with clinical research programs.
Additional degree programs
Several major universities now offer a masters degree in clinical research. These programs differ greatly in terms of the degree awarded (e.g., a masters of science versus masters of health science), the background required for program admission (several are available only to M.D.s or M.D./Ph.D.s), the department that determines the degree requirements, and the specific course work offered. These programs, in keeping with a traditional masters curriculum, are designed to be completed in two years and involve some sort of mentored research project that culminates in a defended thesis.
One of the more substantive degree programs is offered by Duke Universitys School of Medicine through a collaboration with the NIHs Warren G. Magnuson Clinical Center. This program, which began in 1986, requires students to successfully complete seven graded courses, two electives, and a defended research assignment. The required course titles include: An Introduction to Statistical Methods, Principles of Clinical Research, Ethical and Regulatory Aspects of Human Subject Research, Health Economics in Clinical Research, Statistical Analysis, Research Management, and a clinical research seminar series. The choices of electives must then be made from topics such as Clinical Trial Issues, Health Services Research, Genetic Analysis of Human Disease, Psychometrics and Reliability, and Principles of Clinical Pharmacology (3).
As previously stated, many monitors and study coordinators have little or no medical background and thus virtually no academic-level clinical research experience. Even coordinators and monitors with medical training, most of whom are nurses and pharmacists, are exposed to very little academic research. Further, there are many practicing research physicians who, for various reasons, were never formally trained to manage research trials. As a result, there is a great need for educational opportunities outside the traditional academic sphere. To fill the void, a plethora of continuing education (CE) programs have been developed, most of which also provide health care professionals with the CE credit they need to maintain their professional licenses.
The Association of Clinical Research Professionals (ACRP) is the largest (with 13,500 members), and oldest (it began in 1976) organization created to support coordinators and monitors (4). Other smaller groups have come and gone, but this association is the only one to achieve both industrial support and recognition. In addition to its efforts to help members secure employment and stay abreast of a dynamically evolving industry, ACRPs mission has always been one of education. For years, in fact, ACRP has held annual meetings featuring numerous CE programs for member attendees. Specifically, these symposia include topics as practical as Preparing for an FDA Audit, as broad as Fundamentals of Clinical Research Trials, and as specific as The Impact of the International Conference on Harmonization.
In addition to the lecture series, the association provides its members with a quarterly magazine that routinely features articles devoted to educational topics. These articles help monitors and coordinators stay on top of changes in FDA regulations and practices, as well as learn about new research methodologies. One interesting facet of the articles is that reading them can also be used to obtain CE credit; members simply complete a multiple-choice questionnaire after reading each piece, mail it to ACRP, and receive a valid certificate of credit.
ACRP is certainly not the only game in town, however. There are numerous other CE opportunities, many sponsored by members of the research industry. For example, employees of teaching hospitals routinely attend lectures that incorporate various research topics, and many CROs offer in-house courses commonly taught by experienced staff members. Finally, the NIH became part of the act in 1995, when it began directly offering research training courses to physicians via local meetings and national teleconferences (5).
Beginning in the early 1990s, ACRP proposed a certification program for coordinators and monitors. The purpose of the program was to help its members in two distinct ways. First, low starting salaries, high employee turnover, and burnout rates (for monitors, in particular) often define the clinical research industry. Therefore, the ACRP governing board believed that if it began formally recognizing the knowledge and skills of its members, monitors and coordinators would improve their salary opportunities, employment perks, and overall standing in the workplace. Second, board members realized that given the industrys exponential growth, training was increasingly inadequate. It was therefore decided that the research community would embrace opportunities that could result in improved research skills and provide professional certification for individuals with those skills.
ACRPs proposal was implemented and, for almost six years, members who can meet the eligibility requirements and demonstrate competent knowledge of research practices, ethics, and regulations have been eligible for recognition with the designation of Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Associate (CCRA). (In the field, the title of research associate commonly refers to research monitors.)
Competency is determined via a multiple-choice exam given on certain dates and in specified locations. The questions for the exam were originally created by a volunteer team of monitors and coordinators, but, according to ACRP, are now based on the industrys largest validated job analysis to ensure the exams reflect the frequency and importance of what clinical research coordinators (CRCs) and clinical research associates (CRAs) do in the [field] (6).
Before taking the certification test, many individuals attend a preparatory course similar to those for students preparing for scholastic achievement exams. These courses help ready participants for the exam and also serve as excellent training opportunities. The current demand for prep classes has grown to the extent that, this past winter alone, 11 CRA sessions were held in 15 North American cities.
The educated researcher
Over the past decade, both the number of health care professionals involved in research and the number of trials conducted in the United States have grown exponentially. Unfortunately, the opportunities for individuals to learn the ins and outs of their professions have hardly kept up. It is true that there are more ways to learn about clinical research than there used to be. But it is also true that the majority of researchers still learn their jobs by trial and error. Medical schools have long held the belief that physicians need to be instructed in medical practice and that research practice can be self-taught. As a result, investigators often take for granted the complexities of drug development, and monitors and coordinators are left without much guidance. The impact of this lack of knowledge and skill on a participating patients health and overall care is very real, as is the potential for an adverse impact on the quality of clinical data obtained. It is therefore in the best interests of research sponsors to recruit and hire well-trained researchers, just as it is in the interests of those researchers to achieve as high a degree of training as possible.
- University of Texas Medical Branch Galveston, course catalog, academic year 20002001.
- Stanford University School of Medicine, course catalog, academic year 20002001.
- Duke University School of Medicine, course catalog, academic year 20002001.
- Association of Clinical Research Professionals (ACRP). Home Page. www.acrpnet.org (accessed March 2001).
- National Institutes of Health. Training programs in clinical research a priority at the NIH Clinical Center. www.cc.nih.gov/ccc/aboutcc/media_resources/news_features/edu.html (accessed March 2001).
- ACRPs certification program information. www.acrpnet.org/certification/index.html (accessed March 2001).
Cullen T. Vogelson is an assistant editor of Modern Drug Discovery. Send your comments or questions regarding this article to firstname.lastname@example.org or the Editorial Office by fax at 202-776-8166 or by post at 1155 16th Street, NW; Washington, DC 20036.
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