{"title":"Strategies for Defining Key Performance Indicators in Research","authors":"P. Sahai, Rashmi Sahni","doi":"10.14524/CR-16-0010","DOIUrl":"https://doi.org/10.14524/CR-16-0010","url":null,"abstract":"The article explores frequent challenges that research sites confront while setting up key performance indicators (KPIs) to track the success of their clinical research program. Worried about what metrics to track, sites either attempt to measure all research activities or spend considerable time and resources in pursuit of a magical number of metrics. The authors propose best practices for clearly defining objectives and related KPIs. The proposed approach includes a variety of factors that have considerable impact on the success of a study, such as those associated with activation time and accrual. Aligning KPIs to well-defined strategic objectives, the paper concludes, empowers organizations to evaluate processes and outcomes of clinical research more accurately and efficiently.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"33 1","pages":"16-19"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90520514","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Are Performance Metrics About Doing the Right Things or Simply Doing Things Right","authors":"Linda B. Sullivan","doi":"10.14524/CR-16-0015","DOIUrl":"https://doi.org/10.14524/CR-16-0015","url":null,"abstract":"Performance metrics in the clinical trials sector need to be re-imagined so they are better designed to improve study quality. They should become standardized across the industry to benchmark productivity, so that stakeholders can measure project and protocol risk from the beginning. To be effective, performance metrics are aligned with critical success factors and key performance questions, along with metrics that answer them. Driving this effort are industry initiatives and regulatory agencies that encourage greater risk mitigation and management techniques early on. This shift emphasizes using performance metrics to do the right thing to improve operations, which is a departure from simply doing things right—namely, measuring things in check-box fashion.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"100 1","pages":"20-23"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77372406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Data-Tech Connect","authors":"D. Vulcano, Paul Connelly","doi":"10.14524/CR-16-4026","DOIUrl":"https://doi.org/10.14524/CR-16-4026","url":null,"abstract":"At a recent industry conference, representatives of a clinical trial site disclosed to a panel of expert mentors that their site had been attacked by ransomware. Ransomware is a type of malware that encrypts a computer’s data, rendering it useless. The ransomware sender offers the decryption key for a price. This column looks at how ransomware attacks happen, what sites can do to prevent attacks, and what to do if you are attacked (or think you are being attacked).","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"14 1","pages":"36-39"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87168667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Current Practices Within Investigator-Initiated Sponsored Research","authors":"Ashley N. Wills, S. Cunningham","doi":"10.14524/CR-16-0006","DOIUrl":"https://doi.org/10.14524/CR-16-0006","url":null,"abstract":"In 2015, the ACRP Investigator Research Interest Group conducted a survey to gain insights into how investigator-initiated sponsored research (IISR) is conducted, and to provide a valuable benchmark for how researchers and industry manage IISR studies. IISRs are independent research projects in preclinical, clinical, or observational settings where the investigator or institution serves as the sponsor. As presented in this article, it is hoped that the survey findings and follow-up activities will provide a way for both sites and industry to improve their communication about the research their efforts create.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"47 1","pages":"42-49"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85465571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
S. Adcock, Jeremy Kuhn, Andrea Hamilton, G. Atiee, J. Sramek, N. Cutler
{"title":"State-of-the-Art Pharmacy Services","authors":"S. Adcock, Jeremy Kuhn, Andrea Hamilton, G. Atiee, J. Sramek, N. Cutler","doi":"10.14524/CR-16-0002","DOIUrl":"https://doi.org/10.14524/CR-16-0002","url":null,"abstract":"Phase I clinical studies form an important foundation for drug development and the eventual approval of life-saving therapies. The authors review an ideal suite of state-of-the-art pharmacy services in a Phase I clinical research unit that is tailored to the operations of early clinical research. These services span a continuum of practice, from compounding and drug preparation to the novel roles of protocol review, subject training for self-dosing, and drug administration. Also discussed are the topics of pharmacy involvement in drug accountability, manufacturing, and compounding, as well as drug blinding, dispensing, and dosing procedures. Finally, the authors outline the elements of an ideal pharmacy facility.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"3 1","pages":"30-35"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86940253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"CTTI Project Reveals Serious Flaws in Trial Recruitment Protocols","authors":"James Michael Causey","doi":"10.14524/CR-16-4030","DOIUrl":"https://doi.org/10.14524/CR-16-4030","url":null,"abstract":"Failure to address clinical trial recruitment issues at the outset continues to plague sites, according to the findings of a new Clinical Trials Transformation Initiative (CTTI) task force. The result is that nearly 40% of clinical trials fail to meet recruitment goals. Presented here is a Q&A delving into the issue that was conducted by Clinical Researcher ’s editor-in-chief with CTTI Recruitment Project team members Beth Harper, president of Clinical Performance Partners, and Leslie Kelly, a clinical trials recruiting coordinator at Duke for more than 15 years.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"11 1","pages":"40-41"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80017422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Clinical Research Performance and the Use of Metrics","authors":"E. Stevens","doi":"10.14524/CR-16-4034","DOIUrl":"https://doi.org/10.14524/CR-16-4034","url":null,"abstract":"The modern increased push for performance cuts across all industries, including clinical research. Understanding performance and the components which define performance improvement helps us to describe the appropriate selection, use, and interpretation of metrics. For “The Evolving World of Metrics” portion of this issue, the selected authors illustrate varied perspectives on the value and interpretation of metrics in clinical research.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"82 1","pages":"3-3"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80585693","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Measurements, Metrics, and KPIs: Achieving a Balanced Scorecard","authors":"J. Kingsley","doi":"10.14524/CR-16-0014","DOIUrl":"https://doi.org/10.14524/CR-16-0014","url":null,"abstract":"Pharmaceutical, biotechnology, and medical device manufacturers are hiring sites to do one thing: produce high-quality data. In pursuit of that single and seemingly simple goal, research sites have to do hundreds of things, including training highly competent researchers, recruiting numerous appropriately qualified research subjects, and managing complex nuances of the research protocol. It’s difficult enough to implement processes and functions necessary to achieve the goal of producing high-quality data, but if you succeed in implementing the myriad policies and procedures needed, you will have only come half way to the goal. In today’s research environment, key performance indicators (KPIs) are needed, and a tool known as a “balanced scorecard” is a must.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"16 1","pages":"12-15"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90441045","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Culture-Driven Patient Recruitment and Retention","authors":"M. Naughton, Ilona Knudson","doi":"10.14524/CR-16-0013","DOIUrl":"https://doi.org/10.14524/CR-16-0013","url":null,"abstract":"Culture, not language, is the greatest impediment to enrolling patients in international clinical trials. While language obstacles can be overcome with accurate and timely translation, culture’s impact is often overlooked or disregarded when it comes to generating patient participation. Involving a good translation team in the process and leveraging collaboration between its members and local review teams can overcome these barriers, and can increase the efficiency of recruitment and retention programs.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"24 1","pages":"52-55"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73411537","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Keeping Up with Clinical Research Technologies","authors":"P. Smailes","doi":"10.14524/CR-16-4024","DOIUrl":"https://doi.org/10.14524/CR-16-4024","url":null,"abstract":"The goal of this issue is to help readers keep pace with technological trends happening in the research enterprise. While it can be exciting to see how technology makes positive impacts professionally, in the clinical research line of work we also need to think about how technologies are regulated and how they can affect human subjects protections. Technologies may solve old problems, but the reality is that they create new ones, too, for example as paper case report forms (CRFs) turn into electronic CRFs (eCRFs) and, because of eCRFs, onsite monitoring segues into remote, risk-based monitoring.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"6 1","pages":"4-4"},"PeriodicalIF":0.0,"publicationDate":"2016-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81657317","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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