eClinical potential explored

By Kirsty Barnes

- Last updated on GMT

Related tags Edc Clinical trial

As eClinical gathers momentum, spoke to two
contract research organisations (CROs), Icon and Parexel, to get
their views on the present and future of these emerging

Thomson CenterWatch's recent '2007 Survey of Investigative Sites in the US', identified electronic data capture (EDC) technologies as the number one area of potential for best preventing future delays in clinical trials.

Meanwhile, analysts have estimated that 20 per cent of clinical studies around the globe are now being conducted using EDC and predict a complete transition from paper based systems within a decade.

Tom O'Leary, global head of Data Management, and Deborah Holmes, the new global EDC champion at Icon both said that the company's experience with EDC so far is that it "is certainly speeding up the delivery of clinical trials," particularly in the "close out" phase, which is the time from the final patient's last visit, until database lock.

To quantify this, they said that the paper based process takes on average between 4-8 weeks in the close out phase, while EDC-based trials typically close within as many days.

However, some end-users voiced concerns at the recent Drug Information Association (DIA) meeting in Atlanta that in some cases, instead of being a time saviour, in reality EDC is proving to be somewhat of a burden, with factors such as training, IT issues, and duplication of paper and electronic data entry causing study delays while the industry grapples with this new technology.

Commenting on this, Icon, which has recently completed its 100th trial using electronic data capture (EDC), said: "It has to be recognised that the industry overall is still in the early phases of EDC adoption and there are only a handful of organisations who have taken all the required steps to align their clinical development functions to embrace EDC optimally."

However, the firm believes that as EDC adoption becomes more widespread, more and more organisations are taking the time to re-evaluate their case report form, database and reporting structures and standards in order to maximum the benefits the technology can bring.

The company said that by taking advantage of the hosting and helpdesk services being offered by the technology vendors, and by using a CRO experienced in the use of eClinical technology, trial sponsors "can overcome many of the technology adoption challenges organisations face where they try to take all activities in-house."

Dr Barbara Tardiff, corporate vice president of Data Sciences, Clinical Research Services at Parexel added that ultimately, if EDC is integrated and used properly, it can enhance the efficiency of clinical trials by positively impacting a number of different steps in the process, in some cases easing and accelerating activities and in other situations shifting work so that it can occur earlier.

However, there are a number of factors impacting the time required to plan, start-up, execute and report on clinical studies.

In addition, while EDC is applicable to all studies, how it is implemented, applied, and used may vary based on the requirements of a particular study, she said.

Tardiff believes that in the same way that traditional paper-based processes did, EDC implementation and practice will realise increasing efficiency over time.

"EDC requires integration solutions throughout clinical trial planning and execution to eliminate inefficiencies and rework the overall process so that all systems work well together across one technology platform."

"As EDC drives the adoption of industry standards, common approaches and interfaces will help make many activities within a clinical trial, such as patient enrollment, move along more quickly.

The end result will be overall improvement in the speed of clinical trials," she said.

Icon agreed, and stressed that gaining agreement on these new structures and standards "very often causes delays and should not be confused with the technology itself causing delays."

Looking to the future, Parexel, which has a dedicated eClinical arm, Perceptive Informatics, said it believes the real promise of capturing data in electronic form is at the point of care, be it for clinical or research purposes.

"The ability to assign purpose and add value to the data in real time while reducing variance and non-value added steps will result in increased efficiency," said Tardiff.

Moreover, adaptive trials and other data-driven approaches are only possible with EDC and other technologies, integrated in an overall eClinical solution, she said.

Icon added: " EDC technologies will enable more clinical trials to be conducted in a shorter timeframe, assist in the identification of drugs which are not working much earlier in the development process and expedite the delivery of clinical development by facilitating adaptive trial design."

"We believe EDC technologies offer the potential to provide a full integrated solution, from the point of data capture, through to analysis and reporting."

Already many of the leading EDC vendors are forming collaborations and partnerships with interactive voice and web technologies, safety capture and reporting systems, as well as analysis and reporting software in order to make this a reality, the firm said.

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