“The ability to move data between systems in a structured and reliable manner is a key component of any eClinical strategy that a sponsor may profess a wish to develop”
-Steve Heath of Medidata Solutions
NGP. During the research process what are some of the biggest challenges scientists need to overcome and how can your solutions help mitigate these?
SH. Clinical research is about making good science decisions based on data that is as reliable as possible. The pressures of moving candidates through a clinical drug development program that is highly regulated, yet taking place within a very aggressive commercial environment, enhances the need for rapid access to quality data against which timely decisions can be made.
Drug trials have a range of limiting factors, including adequate access to appropriate patients and sites. The latter has lead sponsors to look increasingly at sites in developing countries to complement more traditional locations, such as North America and Western Europe. An easy–to-use technology like Medidata Rave facilitates straightforward inclusion of sites, supports multiple languages, encourages sites in all geographies, particularly in the Pacific Rim, to use electronic data capture (EDC), and so helps ensure adequate and timely flow of ‘clean’ data for analysis by researchers on a global basis.
NGP. What advances have been made in data capture to help enable scientists in the clinical setting bring their life-enhancing treatments to market?
SH. EDC has been available for over a decade. However, effective EDC capable of being deployed, and supported, on a global basis is a more recent phenomenon. Medidata Rave at the study site is a zero client technology, intuitive to use, with built in e-Learning, and supports any language including Chinese and Japanese. The result of implementing Rave is less cost and complexity in deploying EDC to sites globally, and a reduction in the technology burden on sites that want to take part in ‘electronic’ clinical research but don’t want the hassle commonly associated with EDC. Front end simplicity does not, however, mean a lack of back end sophistication. Rave’s powerful algorithms deliver clean data from the site to the sponsor, or their CRO partner. Rave’s back end analytics using ad hoc tools, or direct via SAS, help clinical research scientists satisfy their drive for rapid decision making based on data they can trust, giving them the opportunity to “Fail Fast – Fail Early”.
NGP. Can you outline some of the benefits these solutions have brought particularly in the areas of safety and improving efficiency and reliability?
SH. Effective EDC supports flexible data capture models and rigorous access controls to support the broad range of global regulatory compliance needs. Collection and response to adverse events is a key part of a clinical trial. Post marketing studies offer the ‘latest best chance’ to obtain a wider safety profile on a compound. Efficient EDC solutions, linked with appropriate monitoring mechanisms, can give rapid access to data from many sites and can be very valuable in helping scientists quickly build a more complete picture of how a drug is behaving in a wider population. A well designed electronic protocol allows sponsors to interact more supportively and dynamically with sites, and data delivered via this route is inherently more ‘trustworthy’ than the alternatives.
NGP. Designer is the only CDISC ODM-certified application capable of generating structured protocol information, which will ensure companies can comply with CDISC Study Data Tabulation Model (SDTM) standards. How significant is this aspect for users?
SH. The CDISC project, of which Medidata is an active supporter in deed and word, has injected much needed realism about standards into clinical development in recent years. The ability to move data between systems in a structured and reliable manner is a key component of any eClinical strategy that a sponsor may profess a wish to develop. Medidata Designer is a CDISC compliant technology that allows sponsors, and their CRO/SI partners, to create their clinical protocols in Microsoft Word (per their normal processes) and produce as output ODM compliant XML files. These can be understood by EDC systems such as Rave which is capable of supporting this protocol, and therefore autogenerate CDISC compliant electronic protocols for deployment to sites.
Steve Heath is VP, Head of EMEA (Europe, Middle East, Africa/Australia) for Medidata Solutions. He is responsible for all commercial and operational activities within EMEA for Medidata Solutions. His expertise includes clinical data management, clinical project management, safety and adverse drug reaction reporting systems, ePRO and EDC.