IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For August 2015
By Ed Miseta, Chief Editor, Clinical Leader
The most heavily downloaded article on Clinical Leader for the month of August was a piece I did on a new EU regulation that is attempting to drive clinical trial harmonization. The article featured Dr. Martine Dehlinger-Kremer, Global VP, Medical and Regulatory Affairs for SynteractHCR. According to Dehlinger-Kremer, repealing Directive 2001/20/EC is seen by many as the key to implementing harmonization. Standing by to replace the directive is EU Regulation number 536/3014 of the European Parliament & The Council, which relates to clinical trials on medicinal products for human use. The directive, which is being modified to become a regulation, has been revised to increase interest in conducting trials in the EU, requires no national interpretation, and will create standardization while still leaving room for national laws. Read why Dehlinger-Kremer believes the new regulation will be a huge improvement over what is currently in place and will greatly simplify the entire process of performing trials in the EU. And more importantly, why that will be good news for sponsors, CROs, and, most importantly, patients.
New EU Regulation Set To Drive Clinical Trial Harmonization
The second most downloaded article Featured Ruth Ann Subach, Director of Clinical Operations for Trevena. We often hear speakers discuss Risk-Based Monitoring and the benefits it can deliver to sponsors and CROs. But oftentimes those discussions focus on definitions, position papers, and regulatory guidance. Rarely do they focus on an initial pilot study using the technology, and the lessons learned from it. In this piece, Subach did just that.
Starting with her reasons for wanting to try it out, Subach takes us through her entire thought process, CRO selection, challenges faced, new tools created, and the end results. Her conclusion? RBM works, it is efficient, and it saves time and money. From what she learned, Subach would happily do it again.
Lessons Learned From A Venture Into Risk-Based Monitoring
The final top three article from August 2015 touched on a topic that was of concern to many readers, and also ties in to the subject of Risk-Based Monitoring - Source Document Verification. Kyle Givens, Principal, Consulting Services at Medidata Solutions, recently co-authored a paper on the topic and was willing to share the findings. According to Givens, data has shown that 97 percent of data entered into any EDC system is accurate and does not change. Since a very high percentage of that data is already in good shape, what we need to do is focus on how we can perform clinical monitoring in a much smarter way.
From the article: "We looked at two specific things,” states Given. “First, we looked at the specific impact of SDV on the total number of changes made to data entered into the case-report form. We already knew that only around three percent of all data was changed. However, we knew that not all of those changes were directly related to SDV. There were other data cleaning activities, such as data management and medical review of data, which can generate queries resulting in data changes." The additional tests consisted of looking at the three percent figure to determine how many of the changes were directly related to SDV. Not surprisingly, the number was very small. The study determined that only about 1.1 percent of all data changes were related to SDV.
Source Data Verification: A Quality Control Measure in Clinical Trials