SCRS invites you to learn more about a variety of topics critical to site sustainability and achieving a greater partnership with sites. Download our industry-changing recognized white papers and use the new information to strengthen your position!
A Pilot Study to Examine the Validity and Reliability of a Site Assessment Checklist for the Evaluation of Best Practices in Recruiting Diverse Patient Populations for Clinical Trials
Across the board, stakeholders in the pharmaceutical product development and approval process have recognized the importance of recruiting diverse patient populations in clinical trials. To help make recruitment of diverse patient populations for clinical trials a reality, the Society for Clinical Research Sites (SCRS) created the Diversity Awareness Program, whose aim is to help promote awareness of diversity-related recruitment opportunities via various mechanisms including white papers. Through the program, SCRS has not only helped sites explore and understand the factors that drive successful recruitment of diverse patient populations but also created an assessment tool to guide sites in improving their ability to recruit diverse patient populations. Between 2018 and 2019, members of a diversity working group led by SCRS developed a 27-item checklist that consisted of statements representing best practices in recruitment of diverse patient populations for clinical trials. This checklist was meant to be used by sites to self-assess their own practices and develop an action plan for improvement. It was also important to examine and evaluate the psychometric properties of the checklist before sites used it for self-assessment. This paper describes the efforts made toward the development and psychometric testing of the diversity assessment tool developed to help clinical trial sites self-assess the extent to which they use best practices for recruiting diverse patient populations for clinical trials
Patient Centricity and Virtualizing Technologies in a COVID-19 World
How sites view the digital tools that encourage patient centricity is critically important to clinical trial stakeholders during the COVID-19 era, as decentralized trials are destined to play a larger role. To gauge the sites’ level of acceptance and knowledge about virtualizing technologies, the Society for Clinical Research Sites (SCRS) collaborated with Medidata to conduct an online survey. It took place between May 19 and July 10, 2020, a meaningful time frame as the pandemic was well underway, allowing sites to respond to questions through a “COVID lens”. The survey measured current and anticipated levels of adoption of patient-centric tools, along with the sites’ perspective on patient reactions. A key finding is that unlike the belief of many sponsors that sites are resistant to more digital tools, the survey revealed that sites are receptive to virtualizing technologies, as they facilitate their work and enhance the patient experience. As evidence, only 15.46% of respondents reported using decentralized/virtual trials over the past two years, but 42.11% expected to participate in them over the next two years, nearly tripling current use. As for patients’ reaction, online recruitment technology garnered the most positive feedback, with 87.5% claiming their patients’ experiences were extremely or somewhat positive, followed by televisits at 83.87%.
Sites Speak Out on Clinical Trial Technology Overload
The Society for Clinical Research Sites (SCRS) recently collaborated with IQVIA to conduct a global online site-based survey focused on the expanding volume of clinical trial technologies. The survey aimed to pinpoint the burdens sites face in adopting an array of new systems, each with their own passwords, and requiring training. Key findings showed that the most widely used technology remains electronic data capture (EDC), with nearly 90% reporting using it in at least 75% of their clinical trials. Second to EDC was the clinical trial management system (CTMS), which offers popular functions such as the tracking and invoicing of payments and receivables, but respondents want to see CTMS better integrated with other technologies. Risk-based monitoring (RBM) has been gaining ground, with 29.2% of respondents claiming to use this approach in seven or more clinical trials. The survey was conducted on the cusp of the COVID-19 pandemic, and with sponsors embracing virtual clinical trials, sites and patients will be able to remain safer by decreasing the number of visits, replacing site visits with virtual visits, and increasing remote monitoring.
Impact Assessment of Decentralized Clinical Trials (DCT) Awareness in the Clinical Research Industry
Hybrid Decentralized Clinical Trials (DCT) have the potential to provide tremendous efficiencies to the clinical trial process. While they sound appealing, understanding the great impact they are having on sites and the trial industry is critical to taking the appropriate steps towards implementation. In collaboration with VirTrial, SCRS embarked on a survey and publication initiative to provide this important analysis. Primary concerns and the current state of needs at the site level are centered around assuring patient safety and adequate education and understanding. This white paper expands on those points and several others as we begin to process how valuable DCTs are, and what needs to be done in order to prepare for them.
Impact Assessment of eClinical Technologies and Industry Initiatives on Sites
Sponsors and CROs fight a continuous uphill battle to reduce complexity, streamline business processes and workflows, ensure compliance and increase efficiencies in the pursuit of bringing drugs to market. Fundamental to this goal is a site-centric approach to conducting clinical trials. Sites are dynamic environments, and new technology and industry initiatives are important complements to the critical need for relationship-building and maintenance. But, are these technologies and initiatives helping improve site and sponsor-CRO collaboration and creating a competitive edge through improved clinical trial performance? To explore these issues and their impact, the Society for Clinical Research Sites (SCRS) and Oracle Health Sciences surveyed clinical research site professionals around the world.
Financial Barriers to Site Sustainability, Patient Experience and Overall Trial Success
It is well-known and frequently documented that financial stress is one of the primary issues negatively impacting clinical research site success. Previous data collected by the Society for Clinical Research Sites (SCRS), in partnership with Greenphire, identified four major challenges affecting clinical trial success: limited operating cash, manual invoicing processes, untimely payment frequency and lack of financial transparency are all top of mind for sites globally. These findings are reported in a joint white paper entitled Site Payments and Reimbursements: A Global Perspective.1 However, it is important to understand that the barriers to success are not exclusively correlated to site payments. In fact, the challenges are evident throughout the life-cycle of a clinical study, as early as the study budget negotiation processes and all the way through patient engagement and payments.
Recruiting Diverse Patient Populations in Clinical Studies: Factors That Drive Site Success
In July through November 2017, members of the Society for Clinical Research Sites (SCRS) were invited via email to complete a survey pertaining to site related factors to success in recruiting diverse patient populations in clinical studies. Self-reported success in recruiting diverse patient populations for clinical studies was utilized as the dependent variable and site characteristics were utilized as independent variables. Descriptive, bivariate and multivariate analyses were conducted and are reported.
Patient Diversity Awareness: Developing a Better Understanding of the Knowledge, Expertise, and Best Practices at Clinical Research Sites to Meet the Needs of an Increasingly Diverse United States Population
The FDA has imposed, and continually is tightening the reigns on ensuring that clinical trials enroll racially/ethnically diverse patients. This warrants bolstered safety and efficacy for the representative patient population that will be using new medical products. Sponsors are highly encouraged to obtain a diversified patient population on all trials, not just for particular therapeutic indications. Site interviews were implemented to identify factors that affect the enrollment of diverse patient populations in clinical research trials. In this pilot study, twelve clinical research sites were randomly selected to participate in an interviewing process.
Site Budget Development and Payment Systems: A Call for Transparency from Clinical Research Sites
SCRS research outlines the role technology innovations have on the power to bring transparency and efficiency to the site payment and budget process, however, legacy processes and practices fail to embrace these solutions. This white paper explores potential solutions and reports on site responses identifying features they would find to be the most valuable, providing a potential road map for industry partners to use in addressing these concerns.
Why Is Clinical Source Data Still Collected on Paper?
This white paper builds on data from the Research Site Source Survey, reporting that paper source document creation is a task completed at many sites at significant expense and risk to quality. This task continues despite widespread adoption of electronic medical records and the development of a regulatory framework for eSource. In this paper, the task of paper source document creation and transcription is explored and the total cost calculated.
Site Payments and Patient Reimbursements: A Global Perspective
This white paper presents global data on site perspectives on payments and patient reimbursement. The white paper validates SCRS advocacy for key improvement from payers. It also demonstrates a complex relationship between payment processes to sites and patient payments, linking these key improvements to the patient experience.
Meeting Clinical Trial Site Needs with Patient Recruitment Agency Services White Paper
Innovation in how patients and clinical trials are brought together is urgently needed. Recruitment that takes longer than expected increases the costs of products and prevents new products from being brought to market. Too many studies are canceled because recruitment is never completed. This white paper presents information collected from clinical research sites in the US and five European countries and provides new insights into factors holding back patient recruitment innovation and how they can be overcome.
CLEAR (Common Language Evaluation and Reconciliation) White Paper
The purpose of CLEAR is to streamline contract negotiations and thereby accelerate site initiations, leading to increased recruitment timeliness and reduced study start-up costs. Improving productivity by reducing cycle times and accelerating clinical research will allow industry to get new treatments in development to patients faster without sacrificing quality. This initiative benefits all the stakeholders within industry—sponsors, CROs and sites—but most importantly patients.
Site Study Dashboard White Paper
What if sponsors had a standardized process for sharing information about sites in the form of a Site Study Dashboard? Sponsors have this information readily available. Sites want a dashboard that reflects their performance. This paper lays out nine key metrics that can be shared with sites and the methodology of how the data can be shared to enhance the relationship with the site. It also provides insight into the format of data that sites are most likely to find meaningful.
Site Payment White Paper
This paper documents five burdens the current site payment structure places on sites and solutions to address these issues. Additionally, the paper outlines further burdens that will be examined over 2016-2017 by the SCRS payment initiative working group.
The Approach of Protocol Training on Clinical Trial Quality White Paper
In an era of increasing protocol complexity, growing Investigator complaints and inspections, higher Investigator turnover and the focus on quality by design, it is becoming more important than ever to ensure investigative sites are adequately trained to delivery high quality data. While the 2009 FDA Guidance on Investigator Responsibilities clearly established expectations for what is considered adequate training (and the Investigator’s role in ensuring all staff are appropriately trained), the guidance also reaffirmed that the Investigator should ensure site staff receive relevant information from any sponsor’s training materials if provided.
The Quest for Site Quality and Sustainability White Paper
There are a plethora of industry initiatives focused on enhancing the quality of clinical trials. A subset of these activities is centered on site performance, quality and sustainability. Much of the emphasis however, is on what sponsors (and CROs) need to do to ensure the selection and management of qualified investigators. And much of the focus is defining site quality and performance metrics from the industry perspective. In this quest for site quality and sustainability, the Society of Clinical Research Sites (SCRS) recognized that a key perspective was missing: that of investigative sites. How do the sites view their current levels of quality? How do they feel they can and should be measured? What do they need to do internally to improve their performance and what do they need from their sponsor and CRO partners to enhance their quality as well as sustainability?
Responsible Site Management White Paper
It is anticipated that these are the beginning of Best Site Practices and will continue to evolve with the addition of new information and input from the stakeholders over time. These Best Site Practices are not in any particular order of importance, because it is believed they are all equally necessary to be in place and remain in place during the conduct of any clinical study. It is expected that all local, federal and regulatory laws are strictly adhered to; therefore, details pertaining to each ICH requirement are not reiterated. We believe such regulations fully address the areas needed to ensure human subject protection and should always be fully complied with. These Best Site Practices are meant to provide clarity and guidance to sites to promote the achievement of a compliant, efficient and sustainable research site, and to be recognized as a site of commitment and quality by the research enterprise.
An Industry in Crisis White Paper
In a commentary published in the Journal of the American Medical Association, Robert M. Califf, M.D., Vice Chancellor for Clinical and Translational Research, Duke University Medical Center and Director of the Duke Translational Medicine Institute, stated that while clinical research sites are the “fundamental unit” for evidence- based medicine, “The system responsible for generating that evidence in the United States is in crisis, as demonstrated by erosions of system efficiency, waning interest in clinical research among practitioners, and financial insolvency among participants in the clinical research enterprise.”
Better Payment Terms for Sites White Paper
A new medical therapy has just been approved and the sponsor touts this major achievement by publicizing the clinical trial results and the number of subjects who participated in the pivotal studies. Whether that number is 300 or 3,000, those subjects had to be recruited, enrolled, randomized, and engaged in a series of protocol-related visits to investigative sites, the very backbone of the clinical trials industry. Without sites, it would be virtually impossible to conduct clinical research. And whether those sites are free standing, linked to a medical practice or part of an academic medical center, they are a precious resource. Yet many are struggling, not only with ever more complex protocols, but also with the financial realities of operating a clinical research site.
Site Solutions Summit 2012 White Paper
The renown PGA National Resort and Spa in Palm Beach Gardens, Florida was the site of the 2012 Site Solutions Summit (Summit), the seventh year for this dynamic gathering of clinical trial stakeholders. An established conference dedicated to issues faced by investigative sites and seeking mutually acceptable solutions, this year’s Summit, held October 12 – 14, maintained its constant theme of Partnering for Success, a commitment to the increasing emphasis on collaborations among sites, sponsors, contract research organizations (CROs), and industry providers.
The Global Impact Partners Program White Paper
SCRS and its Leadership Council are committed to building partnership opportunities between its members and sponsors, CROs and professional providers. The Society has developed the Global Impact Partnership (GIP), available to sponsors, CROs and professional providers, to facilitate a unique opportunity to engage with SCRS and its members. An executive from the GIP company will have a seat on the GIP Board. The GIP board will interface with the SCRS’ Leadership Council to helpset strategic initiatives for the Society.