Reports

Topic: Reports

Help Industry Develop Standard Metrics for Site Payments-MCC Site Payments Process Industry Survey

Thursday, April 27, 2017

As an industry, we have a challenge with site payments. Site payment delays have been cited as one of the key concerns by investigators. Data from the Society for Clinical Research Sites (SCRS) says that 66% of sites report having less than three months’ operating cash on hand, and lengthy delays in payment result in high turnover rates among clinical investigators1. The Clinical Trials Transformation Initiative (CTTI) shows as many as 40% of sites drop out of FDA-regulated clinical trials due to lengthy delays in payments2. By standardizing metrics in this important area, the industry will be better able to baseline, compare, manage and improve performance and ultimately increase the available pool of sites for clinical trials.

The Metrics Champion Consortium is conducting this survey as a baseline exercise before developing metrics. We invite industry Sponsor, CRO and Clinical Trial Site Payment Vendors to participate in this 11 question survey. All responses will remain confidential to the MCC – only de-identified data will be shared in the executive summary and final report. Professionals who complete the survey and include their email address will receive an executive summary.

TAKE SURVEY

1SCRS White Paper on Site Payments[http://www.prnewswire.com/news-releases/site-payment-white-paper-released-by-the-society-for-clinical-research-sites-300352486.html]

2CTTI Outsourcing-Pharma.com Article[http://www.outsourcing-pharma.com/Clinical-Development/Payment-tech-automates-reimbursements-to-clinical-trial-sites]

MCC Article Urges Industry to Standardize Data Entry Metric Definition and Use Performance Data to Improve Data Entry Compliance

Wednesday, April 26, 2017

Linda Sullivan, MCC President, and Keith Dorricott, MCC Ambassador – discussed the results of the 2016 MCC Site Data Entry Practices Survey in their article “Importance of Data Entry Timeliness” published by Applied Clinical Trials. The article reveals that organizations consider timely data entry to be very important but face challenges with measuring and monitoring the data input process. A newly released MCC Industry Practices Insight Report, “Clinical Trial Site Data Entry Study: An examination of how organizations measure site data entry cycle times, performance expectations compared to actual results and site management strategies” provides industry’s perspective on the cycle time from subject visit to data entry by investigative sites, and how organizations use the performance data to improve data entry compliance.

About the Survey

MCC conducted the 28 question, web-based survey between June – August 2016. There were 35 respondents primarily from sponsors and Contract Research Organizations (CROs) both large and small. For more information on purchasing this and other MCC Industry Practices Insight Reports, please email Customer Service
or visit our Industry Practices Insights Report Page

Read Linda Sullivan and Keith Dorricott’s article on Applied Clinical Trials Online

Site Data Entry Cycle Time Definitions Vary and Actual Values Exceed Expectations Undermining Risk-based Study Quality Monitoring

Wednesday, April 5, 2017

Boston, MA. April 05, 2017 – Metrics Champion Consortium (MCC)—a trusted partner in the clinical trials industry—announced today a newly published MCC Industry Practices Insight Report, “Clinical Trial Site Data Entry Study: An examination of how organizations measure site data entry cycle times, performance expectations compared to actual results and site management strategies” revealing that organizations consider this to be a very important metric. The report features twenty exhibits highlighting the following key findings:

  • Organizations encourage timely data entry to identify safety signals early and increase data quality.
  • Industry lacks agreement on how to define the “data entry complete” time point – data entry “complete” when a single data point for the visit has been entered into EDC and data entry “complete” when all data for a complete visit have been entered into EDC are most prevalent responses
  • Site data entry cycle time expectations for “single data” time point group not significantly different from “all data” entered group
  • Some organizations cite challenges with measuring data entry cycle time related to EDC system constraints.

“With the adoption of the ICH E6 (R2) Addendum and the increasing focus on risk management in clinical trials, timely data entry by sites following subject visits is becoming more important,” said Linda Sullivan, co-founder and president at the industry group Metrics Champion Consortium, author of the new report. “Delayed data entry can lead to increased risk both to subjects and the trial. This study shines light on a real industry gap that could itself be a significant source of risk unless urgently addressed. It’s time for the industry to come together across the value chain to resolve the definition, use, expectations and continuous improvement of this important cycle time metric.”

MCC conducted the 28 question, web-based survey between June – August 2016. There were 35 respondents primarily from sponsors and Contract Research Organizations (CROs) both large and small. For more information on purchasing the MCC Industry Practices Insight Report, “Clinical Trial Site Data Entry Study: An examination of how organizations measure site data entry cycle times, performance expectations compared to actual results and site management strategies”, please email customerservice@metricschampion.org or visit http://metricschampion.org/sitedataentrystudy/

About Metrics Champion Consortium (MCC)

MCC—a trusted partner in the clinical trials industry—identifies what to measure, how to assess the crucial components of what is changing and how the industry is responding to address these changes to make improvements. MCC continually brings you new insights into the leading trends within the industry. For more information about MCC metric sets and tools, metric education programs and how you can participate in MCC work groups, please visit http://www.metricschampion.org

Contact:

Linda Sullivan

lsullivan@metricschampion.org

317-622-0266