Worldwide Data Capture
Integrating data from many global clinical sites can be a real challenge, reports Ross Rothmeier, senior director, EDC Portfolio, Covance. “It can get complicated to combine data obtained from multiple sources in global clinical trials. But this is important because submissions require all the data collected, and it has to be in a consistent format to review.”
According to Rothmeier, it is particularly challenging to have straightforward and easy access to site and laboratory data coming from multiple locations—especially on a global scale. One solution is electronic data capture (EDC).
“If you have sites in 47 countries in a clinical trial and are using multiple labs,” explains Rothmeier, “it can be difficult to get an overall view of the data in the trial. Solutions requiring loading and converting data into a site’s computer, or collecting it on paper and then transcribing it into another system, are cumbersome and introduce many points of potential failure and error.
“EDC allows the entry of data into a central repository and uses edit checks during entry that help reduce errors. Whether entered at the investigator site or transmitted directly from a laboratory, EDC simplifies the process and increases data quality. The central repository makes this data available to anyone who has authorized access, regardless of location, and does so more quickly than paper or decentralized systems.”
Rothmeier adds that another challenge for the industry is adopting data-definition standards. “Many organizations are being very forward thinking in endorsing industry standards such as CDISC (Clinical Data Interchange Standards Consortium) and HL7 (Health Level 7) that provide specific guidelines for data interchange. This is important as it enables data from multiple sources to be combined without converting or transcribing it to a proprietary format. This further simplifies the process and reduces the challenges of conducting a global trial.”
When forming partnerships with CROs, companies often employ one of two approaches, transactional or strategic, says Daniel Spasic, CEO, Trial Form Support International (TFS).
According to Spasic, a transactional approach means, “that a company chooses to tactically outsource projects and assignments based on what is most suitable for the project. But this approach also suffers from not charting a clear pattern since it is based primarily on each individual project. Therefore, you can end up with several providers, problems with internal administrative coordination, and underutilized cost benefits.”
Spasic believes that using a strategic approach that employs a few selected providers makes more sense. “With a strategic approach you would choose one CRO for data management and a different CRO for clinical development work. This will be more efficient in the long run because it will save internal administration time and you will likely get better pricing and attention since the CRO you are outsourcing to can rely on more regular workflow.”
Another important issue to consider when selecting a CRO is where the company conducts its clinical trials and the extent of its geographical reach. “This depends on what is being outsourced and the development phase of the clinical trial. If a company is outsourcing early clinical development, that could be done locally with specialized units. Here you must look primarily for competence and experience, and what technical capabilities the unit has.
“But, if you do proof-of-concept studies with 100–250 subjects,” he continues, “then that can be regionalized to three or four countries in Europe, or only the U.S. Mid- to large-sized CROs are appropriate for these. If you are conducting pivotal Phase III trials, however, you need to do that on several continents and there you’d select bigger CROs with the possibility to support you through its own global infrastructure.”
Spasic expects lively discussions at the Orlando meeting as to which countries are the best for outsourcing. “There are major concerns that the U.S. will lose out on trials because federal regulations and lack of patient interest slow down the process. But wherever a trial is conducted, including China and India, each place will have unique advantages as well as disadvantages. There is no one right place.”
TFS currently has approximately 200 clinical studies of which 15% are in the U.S.