FREE Monitor Table of Contents, Lead Article

About the February 2014 Issue

Although the journey from first-patient-in to last-patient-out in a large study may, at the outset, seem as complicated as winding from point A to point B in a piece of M.C. Escher-like art, today’s complex study designs reward the dedicated efforts of researchers to plan, execute, and oversee the conduct of trials with disciplined rigor by advancing drug and device development with reliable results.

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Free Lead Article

FDA Guidance for IRBs: Implications for Investigators
Raffaella Hart, CIP
The U.S. Food and Drug Administration (FDA) has issued new draft guidance for the management of clinical trials in which the agency stresses the role of institutional review boards (IRBs) in evaluating the qualifications of clinical investigators and the adequacy of research sites. By understanding these guidelines, research institutions can mitigate against the risk of receiving Warning Letters or regulatory audits from the FDA.

Opportunities in the Evolving Complexities of Clinical Research
Lynn D. Van Dermark, RN, BSN, MBA, CCRA, RAC

The Complexities of Accountability and Competency
Samuel Simha, MD, FACOG, CPI

The Complexity of Clinical Trial Management
FDA Guidance for IRBs: Implications for Investigators
Raffaella Hart, CIP
The U.S. Food and Drug Administration (FDA) has issued new draft guidance for the management of clinical trials in which the agency stresses the role of institutional review boards (IRBs) in evaluating the qualifications of clinical investigators and the adequacy of research sites. By understanding these guidelines, research institutions can mitigate against the risk of receiving Warning Letters or regulatory audits from the FDA.

Clinical Research Nurse Perspectives on Unsupervised, Non-Nurse Clinical Research Coordinators
Carolynn Thomas Jones, MSPH, DNP, RN | Lynda Law Wilson, PhD, RN, FAAC
Increasing reports in the literature describe the roles and competencies required of clinical research coordinators (CRCs), and increasing complexity and intensity of clinical research studies have intensified the need for educated and experienced professionals in this position. Many CRCs have clinical nursing preparation, which some might argue is needed for components of the CRC role that include direct patient care or assessment of potential adverse reactions to study drugs or interventions. However, many CRCs do not have clinical nursing preparation. Few studies have compared the roles and activities of nurse and non-nurse CRCs (NNCRCs). Respondents to the survey described in this article reported that NNCRCs were performing most of the activities of nurse CRCs, but perceived that NNCRCs should not be performing many of these activities without supervision. Findings suggest the need for further research to clarify the scope of practice for NNCRCs.

Conducting Pharmaceutical Clinical Trials in India: A Clinical Operations Perspective
Niharika Kamat, MS | Linda Huynh, MPH | Ansy Mathews, MS | Joy Yllana, MS
Despite the availability of high-caliber medical professionals in India, the majority of the population faces a lack of access to cost-effective, new therapies. Clinical trials provide access to these therapies and comprehensive medical care, which otherwise would be inaccessible. Since the 1990s, India has become a fast-growing, emerging market for drug companies with hundreds of clinical trials in various therapeutic areas. However, in 2010, declines in new trials and sponsor investment were observed, resulting in a closer look at the underlying issues, such as regulatory processes and startup challenges. India remains a small player in the world's clinical trials. This article highlights several logistical considerations when planning and implementing clinical trials in India, utilizing clinical operations perspectives from observational, postmarket, and pediatric studies.

Training Clinical Trial Teams: Current Training Practices and Educational Needs of Clinical Research Personnel
Christina M. Canter, MT(ASCP), MEd, CCRP, RAC | Kadriye O. Lewis, EdD
Research into the education and training of clinical trial personnel is a neglected area, although research team members have the great responsibility of ensuring the safety of human subjects. This case study used a qualitative, phenomenological research paradigm utilizing semistructured, asynchronous, online interviews with 13 clinical research team members across the United States to gather data regarding research personnel training and their educational experiences. Current training practices need to be updated to offer clinical research personnel a strong educational foundation. The findings revealed that deficiencies exist in research training for clinical trial personnel, with 70% of respondents indicating their initial training in research did not prepare them for their job responsibilities. High turnover and hectic schedules appear to be the largest issues related to training, both initially and on an ongoing basis. Current training methods were not in line with the types of learning that clinical research personnel indicated they preferred.

Clinical Monitoring in a Federally Funded Environment: Evolution and Opportunities in the Cardiovascular Cell Therapy Research Network
Sibi R. Mathew | Kristen D. Lucas, MS | Shelly L. Sayre, MPH | Judy Bettencourt, MPH | Tina Collins, RN, BSN | Dana Leach, DNP, ARNP-C | Rachel E. Olson, MS, MBA, RN, CCRC | Doris A. Taylor, PhD, FAHA, FACC |
Lemuel Moyé, MD, PhD
Well-conducted, randomized clinical trials represent a gold standard for research in the scientific community. A well-developed monitoring program is critical in multicenter trials to ensure data accuracy and ultimately demonstrate safety and efficacy of the treatment. While monitoring has traditionally been dominated by onsite industry models, alternative approaches are emerging in investigator- and network-initiated studies, including establishing collaborative relationships with centers, utilizing a team approach to ensure effective monitoring, and implementing remote and risk-based monitoring. In an era of diminishing research resources, thoughtful use of monitoring models must be applied. The federally funded Cardiovascular Cell Therapy Research Network (CCTRN) investigates new cardiovascular treatments using stem cells. This collaborative environment provides opportunities for innovation in monitoring. This paper describes the experience of clinical monitoring in CCTRN, contrasts it with industry-based models, and highlights the evolution and opportunities in what has become a well-integrated monitoring program in an active research network.
Electronic Data Capture: Six Sigma and Metrics to Drive Performance
Ashish Rastogi, MBBS
Electronic data capture (EDC) has become the norm in clinical research, with advantages that are well known and accepted in terms of allowing EDC’s various stakeholders to manage project timelines. Six Sigma is a quality management technique used mostly in manufacturing industry; however, it can be used successfully to improve the quality of any process. This article describes the use of available EDC metrics to manage and improve site performance by incorporating Six Sigma techniques. The article presents three case studies from India, where a performance metric was developed and implemented as part of Six Sigma.

Drug-Induced Liver Injury Continues to Haunt Drug Development: Why This is Still a Problem and How to Identify it Early
Charles H. Pierce, MD, PhD, FCP, CPI
The one overlying and all-important function of clinical research is to protect the welfare and safety of not only the subjects of research, but also of those members of the general public who will be prescribed tomorrow the medicines being studied today. As highlighted in this article, one problem that has long been a thorn in the sides of medical researchers is drug-induced liver injury, which is the most frequent single cause of safety-related drug development and drug marketing withdrawals in the past 50 years.

Getting the Most from Your Clinical and Translational Science Award
Erika J. Stevens, MA | Jim Moran, JD, BS, CPA
At the end of the initial five-year funding period for a Clinical and Translational Science Award (CTSA) from the National Institutes of Health (NIH), institutions can apply for a renewal grant for another five years. This is not, as some have perceived it, a mere formality. The NIH is cracking down on institutions that did not have much to show for their original promises when it came time for renewals; and as a result, some institutions have experienced funding reductions. What many institutions are realizing through the CTSA grant process is that monetary support is not the only catalyst for transformation. Historic business processes are often rooted so firmly within an institution that true change is difficult, and the healthcare industry is the poster child for this phenomenon. This article explores some of the common pitfalls that institutions have been facing since receiving the award, and how they can better use the award to its full potential.

Translation of Informed Consent in Clinical Trials
Zoe Laventhol | Afaf Steiert, MSc
Given that clinical trial participants often are treated with completely new drugs and medicines, ensuring their informed consent is ethically and legally integral to clinical trial proceedings. As with practices in many industries of global scale, clinical trials are beginning to be outsourced. It is extremely important that participants in clinical trials are accurately informed of the precise details of the study in a way that they can understand, as miscommunications about the effects of a drug could have disastrous and even life-threatening effects. Thus, the language translation of informed consent documents must be held to high standards. Informed consent translation can face a number of challenges resulting from a lack of linguistic or even cultural equivalents for key concepts, and the fact that some participants may not be proficient in a country's official language must also be taken into account.

Using Soft Skills in Clinical Research
Carol Opalek, MSN, CCRC, CCRA
Almost anyone can learn to make a spreadsheet and an exhaustive checklist to monitor metrics or to ensure that steps are taken to maintain compliance in a clinical trial. These tasks are, in fact, integral parts of a research professional's role. Less recognized, although by no means less valuable, are a research professional's "soft skills." Soft skills are not as readily learned as tasks such as Excel spreadsheets or checklists; in fact, they are often considered to be simply built into one's personality. However, by raising awareness of the nature and elements of soft skills and learning to incorporate them into one’s interactions with others, these skills can prove to be among the most valuable assets in a professional’s clinical research career.

The Impact of the Federal Shutdown on Academic Medical Centers: Hindering the Process of Discovery
Paula Smailes, RN, MSN, CCRC, CCRP

An Interview with David M. Vulcano, LCSW, MBA, CIP, RAC
Beth D. Harper, MBA

Pervasive Complexity
Kirk Mousley, MSEE, PhD

Medical Device Recalls: From First Alert to Effectiveness Checks
Roberta A. Buckles, BSN, MPH

Challenging the Complexities of Clinical Research
Gary W. Cramer

Lesser Known Guidances and CRF Cautions
Michael R. Hamrell, PhD, RAC, FRAPS, RQAP-GCP, CCRA

Fraud and Abuse Laws and Physician, Hospital, and Industry Relations
Brent A. Ibata, PhD, JD, MPH, RAC, CCRC

Home Study: Clinical Trial Management
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