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Managing the Challenges
The challenges facing today’s clinical operations director are many, including accurately measur ing siteperformance,managing partner relation ships,andovercomingthecommunications barriers between clinical and data operations. Our experts discuss these and other hurdles that are all part of theevolving clinical process. GOTTINGSMITH. ASTRAZENECA. We have entered an era of radical change for clinical program delivery. The pharmaceutical indus try is experiencing pressures on price, earlier entry of generics, and lower output of new approved medicines. R&D spending has increased 70% during the last decade. Deliv ery of the clinical programs has a critical impact on both the time to delivery and the cost required to develop new medicines. The focus on improving clinical operations and finding new models to deliver has intensified over the last five to seven years. Many options for different elements of operational delivery have emerged, ranging from centralized data management in lowcost countries to offshore options for medical writing and safety surveil lance. The large size of clinical programs, new technological solutions, new requirements for translational science, and the conducting of studies across 20 or more countries has result ed in a large, global, and complex infrastruc ture that is expensive to manage. The main requirements for new operational models are, therefore, centered on consolidation, driving adherence to simple standards, accessing the best and most experienced talent, and finding costeffective options while maintaining qual ity. GORDON. KING PHARMACEUTICALS. Within the clinical operations segment of the pharma ceutical industry, improvements in availabili ty of trained human resources are needed. The identification and recruitment of personnel with the appropriate skills and experience are enormous challenges. Currently, training in the clinical operations function occurs primar ily inhouse, because there are few academic programs preparing people to work specifical ly in this field. Most of the candidates for clin ical operations who we see have a sound scien tific knowledge base and come from a pharmacy, nursing, or scientific background. Yet, when a person assumes a clinical opera tions position, there is often a learning curve in developing the necessary skills for the posi tion. Not only is it a challenge to identify individuals who know and understand the clinical operations process in the United BY ROBIN ROBINSON Keeping Pace WITH THE CHANGES IN CLINICAL OPERATIONS The clinical operations function is a crucial element in the overall success of a pharmaceutical organization, and like the rest of the industry, the individuals who are on the clinical front line are facing pressure to do more, faster, better, and of course, more costeffectively. PharmaVOICE asked industry experts to find out how the changing environment is affecting clinical operations. # 10 J un e 2 008 PharmaVOICE PV0608 Layout FINAL2 5/20/08 12:44 AM Page 10 CLINICAL operations States, but it is increasingly difficult to find individuals with experience in global clinical studies, where a number of studies are now conducted. DOYLE.KFORCE.There are several challenging areas facing today’s clinical operations man agers. First, there is a need to focus on cycle times and how to improve efficiencies within site management, which will positively impact site and study collaboration. If pro cesses can be improved and errors can be reduced, then collectively we can improve the industry as a whole. To accomplish these goals, we can look to other industries, such as the IT and automotive industries and leverage the process improvements they have gained by fully outsourcing specific functions to strategic partners. Patient recruitment and improved investigator performance are two other critical success factors to any trial. There is a renewed focus on measuring site perfor mance in terms of recruiting patients and developing better relationships with those who are participating. By applying lean oper ational processes to measure and improve effi ciencies, we can improve the quality of life for monitors and directly impact cycle times as institutional process redundancies are elimi nated. Managers should be analyzing current MICHAEL J. BUTLER,PH.D.Chief Scientific Officer, Aptuit Inc., Greenwich,Conn.; Aptuit is a pharmaceutical service company that conducts research, development,and manufacturing on a contract basis. For more information, visit aptuit.com. ELEANORE DOYLE.GroupVP,Clinical Research,Kforce Inc.,Tampa,Fla.; Kforce is a professional outsourcing firm providing flexible and permanent solutions for organizations in the technology, finance and accounting,clinical research, and health and lifesciences sectors. For more information, visit kforce.com. CHERYLE EVANS.Executive Director, Operations,Essential Group Inc., Gurnee, Ill.; Essential Group is a specialized CRO and patientrecruitment service organization.For more information, visit essentialgroupinc.com. SUSANGORDON.VP,Clinical Operations, King Pharmaceuticals Inc., Bristol,Tenn.; King Pharmaceuticals is a vertically integrated branded pharmaceutical company that develops,manufactures, and markets therapies and technologies in specialtydriven markets.For more information, visit kingpharm.com. KARENGOTTINGSMITH,PH.D.VP, Business Performance and Continuous Improvement (formerly VP, U.S. Clinical Development),AstraZeneca,Wilmington, Del.; AstraZeneca is an international healthcare business engaged in the research, development,manufacture,and marketing of prescription pharmaceuticals.For more information, visit astrazenecaus.com. MARYT.STEFANZICK.Associate Director of Operations,Criterium Inc., Saratoga Springs, N.Y.; Criterium is a global, fullservice, and technologydriven contract research organization that offers a mix of clinicalresearch solutions for the biopharmaceutical,pharmaceutical, medicaldevice,and CRO industries. For more information, visit criteriuminc.com. JAYETHOMPSON,PH.D.SeniorVP, Emerging Biotech &Device Business, inVentiv Clinical Solutions,Houston; inVentiv Clinical Solutions,a division of inVentiv Health,provides flexible, scalable clinicaldevelopment solutions, including trial management,monitoring,data management,statistics,medical writing, regulatory,and clinical staffing.For more information,visit inventivclinical.com. RONALD S.WAIFE.President,Waife & Associates Inc., Needham,Mass.;Waife is a management consulting company focused on the clinicalresearch process for biopharma,devices,and CROs.For more information, visit waife.com. The only way to better manage data and results is through continued focus on standardization using CDISC or HL7. ELEANORE DOYLE KFORCE CLINICAL RESEARCH # 11 PharmaVOICE J un e 200 8 PV0608 Layout FINAL2 5/20/08 12:44 AM Page 11 CLINICAL operations processes to understand if assigning monitors to sites instead of trials might be a more efficient way of resourcing. For example, they should evaluate whether it makes more sense to send multiple monitors to the same site to monitor multiple studies, or does it make better sense to send one monitor to the same site and align them across therapeutic areas for greater efficiencies. Improving the myriad technology sys tems used for communications and reducing the instance of duplicate data entry will reduce the overall time con sumed in redundant processes and also provide greater visibility to lead indica tors, rather than reacting to lag indicators. Retention of staff is another critical element in the overall cycle time of a trial, and empowering frontline teams to achieve oper ational excellence and execute accordingly will be a powerful tool in reducing turnover. EVANS. ESSENTIAL GROUP. I believe there are two major areas for improvement in the clini cal operations space. One is to improve turnaround times of approved monitoring reports via electronic reports with esigna tures. CRAs must be able to access a Web based CTMS (clinical trial management sys tem) database to import and export data while at the site. It is also important that they have the ability to generate the monitoring report in real time during the visit. By doing this, monitors could decrease turnaround times by days or even weeks compared with traditional methods. This not only improves quality but in many cases could favorably impact site pay ments. Sites are motivated to enroll more patients when payments are timely. The other aspect involves improved CRF or EDC mod ule designs that minimize redundancies in data collection, minimize collection of unnec essary data points, and are intuitive to the study coordinators while still meeting the needs of data management. THOMPSON. INVENTIV CLINICAL. The industry is in dire need of common tools and metrics that can be used across studies and sites to optimize overall project management. Specifi cally, we need common metrics that can be tracked on both a historical basis to ensure site/study productivity as well as during the actual conduct of the clinical trial to ensure that corrective actions can be put in place before a clinical trial is in jeopardy. GORDON. KING PHARMACEUTICALS. There is also a need to refine EDC, a tool that has dra matically advanced in the last decade allowing site clinicians to capture data in real time. Many challenges remain in optimizing the production of these tools accurately and expe diently. Moving toward a system based on EDC allows information to be better integrat ed and more efficiently downloaded at the end of the study, but improvements are needed in study startup requirements. In addition to EDC use by clinicians, recording of patient data electronically has improved accuracy by allowing patients to efficiently report progress in real time. This concept has evolved sub stantially over the past 10 years, but there is room for improvement in the development and validation of patientfriendly data capture systems. STEFANZICK. CRITERIUM. There is always room for improvement in communications and workflow, and that is an ongoing process. A clinical operations manager needs to be con sistently attentive to the systems, the people, and how they interact with each other in each study. For instance, studies should have teams of inhouse monitors or clinical data liaisons who communicate with monitors in the field. Breaking down the division between clinical and data operations improves communica tions, speeds up the data flow, and maximizes the use of technology for better data manage ment and reporting. BUTLER. APTUIT. Integrating operations to remove the inefficiencies that exist because of traditional operational silos is a necessary improvement as the industry works to elimi nate the obstacles and redundancies that slow drug development and clinical operations. Integration at an operational level requires drug developers to leverage available scientific expertise and organize project teams in such a way that scientists ordinarily involved in sep arate aspects of the project collaborate at an early stage to anticipate and address potential inefficiencies. By taking advantage of the syn ergies that are inherent in the scientific pro cess, we not only anticipate and overcome organizational obstacles, but also gain better insight into the drugs being developed, see improved safety data, and advance drugs into the clinic more efficiently. GOTTINGSMITH. ASTRAZENECA. Techniques that focus on the voice of the customer and analyze current inhouse capabilities and activities are just a couple of approaches we are using to determine which activities may be DR.KAREN GOTTINGSMITH ASTRAZENECA The focus on improving clinical operations and looking for new models has intensified over the last five to seven years. # 12 J u n e 20 08 PharmaVOICE PV0608 Layout FINAL2 5/20/08 12:44 AM Page 12 Sound Bites From the Field Larry Brownstein, MBA, is Chief Administrative Officer of CRI Worldwide, Clementon, N.J., a clinical research company committed to helping find safer and more effective treatments to central nervous system disorders. For more information, visit criww.com. Rebecca Causey is VP of Clinical Development Operations Americas at INC Research Inc., Raleigh, N.C., which is a therapeutically focused CRO with a trusted process for delivering reliable results. For more information, visit incresearch.com. Robbie Franks, RN, BSN, is VP of Clinical Operations at Trio Clinical Research, Durham, N.C., a clinical research services company supporting the pharmaceutical, biotechnology, and medical-device industries in their quest to bring novel products to the market. For more information, visit trioclinicalresearch.com. Renate Gast-Heimann is Corporate VP of Clinical Operations, Clinical Research Services, at Parexel International Corp., Waltham, Mass., a global services organization that provides expertise in integrated clinical development, medical communications, and regulatory affairs, as well as technologies to expedite time-to-market. For more information, visit parexel.com. Bill Gwinn JR. is VP, New Product Development, at Inclinix Inc., Wilmington, N.C., an enrollment CRO and resource for clinical-trial recruitment solutions. For more information, visit inclinix.com. Michael Harte is Senior VP, Strategic Accounts, at etrials Worldwide Inc., Morrisville, N.C., an e-clinical software and services company that provides services to pharmaceutical, biotech, and contract research organizations. For more information, visit etrials.com. Karen Massand is Managing Director, Strategic Advisory at Skila, Morris Plains, N.J., a provider of knowledge-driven management solutions for the pharma industry. For more information, visit skila.com. Thought Leaders Michael J. Butler, Ph.D. Chief Scientific Officer, Aptuit Inc., Greenwich, Conn.; Aptuit is a pharmaceutical service company that conducts research, development, and manufacturing on a contract basis. For more information, visit aptuit.com. Eleanore Doyle. Group VP, Clinical Research, Kforce Inc., Tampa, Fla.; Kforce is a professional outsourcing firm providing flexible and permanent solutions for organizations in the technology, finance and accounting, clinical research, and health and life-sciences sectors. For more information, visit kforce.com. Cheryle Evans. Executive Director, Operations, Essential Group Inc., Gurnee, Ill.; Essential Group is a specialized CRO and patient-recruitment service organization. For more information, visit essentialgroupinc.com. Susan Gordon. VP, Clinical Operations, King Pharmaceuticals Inc., Bristol, Tenn.; King Pharmaceuticals is a vertically integrated branded pharmaceutical company that develops, manufactures, and markets therapies and technologies in specialty-driven markets. For more information, visit kingpharm.com. Karen Gotting-Smith, Ph.D. VP, Business Performance and Continuous Improvement (formerly VP, U.S. Clinical Development), AstraZeneca, Wilmington, Del.; AstraZeneca is an international healthcare business engaged in the research, development, manufacture, and marketing of prescription pharmaceuticals. For more information, visit astrazeneca-us.com. Mary T. Stefanzick. Associate Director of Operations, Criterium Inc., Saratoga Springs, N.Y.; Criterium is a global, full-service, and technology-driven contract research organization that offers a mix of clinical-research solutions for the biopharmaceutical, pharmaceutical, medical-device, and CRO industries. For more information, visit criteriuminc.com. Jaye Thompson, Ph.D. Senior VP, Emerging Biotech & Device Business, inVentiv Clinical Solutions, Houston; inVentiv Clinical Solutions, a division of inVentiv Health, provides flexible, scalable clinical-development solutions, including trial management, monitoring, data management, statistics, medical writing, regulatory, and clinical staffing. For more information, visit inventivclinical.com. Ronald S. Waife. President, Waife & Associates Inc., Needham, Mass.; Waife is a management consulting company focused on the clinical-research process for biopharma, devices, and CROs. For more information, visit waife.com.