Resistance to change continues

There has been a dramatic shift in the drug discovery industry in recent years, with computing power and informatics becoming an integral part of the discovery and development process.

With lifescience and pharmaceutical companies showing a definite inclination towards electronic technologies and investing substantial amounts in moving from

paper-based to electronic processes, revenues in the eClinical trials (eCT) market are expected to increase from approximately E173m in 2004 to E294m in 2011.

However, according to the World eClinical trials market report from Frost & Sullivan (F&S), the adoption of eClinical technologies currently remain largely confined to pilot projects, barring a few implementations by some major pharmaceutical companies. The adoption of these technologies is dependent on the ability of the senior management in an organisation to take the electronic revolution to the grassroots level.

“In eCT, it is the human element of resistance to change that is the greatest challenge rather than the technology itself,” remarks F&S research analyst Raghavendra Chitta. “This is why the majority of adoption, thus far, has been in the form of small pilot projects.”

The resistance mainly stems from research scientists in lifescience companies since there is great reluctance among them to accept newer electronic processes. Shifting to eCT technologies would not only mean adapting to more technically sophisticated processes, but could also require a complete redistribution of roles and responsibilities.

Moreover, companies need to implement eCT technologies across their organisations for them to be truly successful. Implementing these technologies in isolation in a few clinical research teams will not yield the desired results. Therefore, the major task at hand for eCT technology vendors is to convince all stakeholders in the clinical trials process to adopt and integrate these technologies across the organisation.

However, for vendors to be able to take adoption levels beyond the pilot stage and into enterprise-wide implementation, the real challenge is to provide a compelling return on investment (ROI) to lifescience and pharmaceutical companies.

“Since implementing eCT applications involves major expenditure for creating new infrastructure, changing the business processes, training and support, eCT vendors will have to develop sound ROI models and proof of concepts,” says Chitta. “The challenge for vendors is to identify the right kind of parameters and develop robust ROI models to substantiate their implementation.”

Vendors must work at leveraging the advantages gained by implementing eCT technologies, such as real-time availability of data, to increase their adoption. Since the clinical trials process is electronics based, the patient data is entered into electronic media, which has real-time data validation checks, instead of in paper-based case report forms (CRF).

This process allows the data to be cleaned at the point of entry itself, which enables considerable savings in data entry and curing. By reducing the time taken to transfer the data from the patient to the regulatory authority, electronics-based processes also help improve productivity to a great extent.

Regulatory acceptance of clinical data standards devised by emerging organisations such as Clinical Data Interchange Standards Consortium (CDISC) is helping promote the uptake of eCT technologies by allowing greater integration of data standards.

The growing number of strategic alliances between eCT technology vendors and contract research organisations (CROs) also reflect the increasing adoption of these tools in drug development.

Strategic alliances

One of the most prolific alliance formers at the moment is etrials Worldwide, an eClinical software and services company offering pharmaceutical, biotechnology and CROss worldwide a suite of technology-based tools including electronic data capture, electronic patient diaries, interactive voice response and reporting.

Its most recent tie up is with INC Research, a leading CRO that specialises in therapeutics. For over two decades, the company has been dedicated to managing all aspects of global clinical development programs for pharmaceutical and biotechnology customers and tailors its full range of services, processes and technology to the unique needs of each client and their specific project requirements

Under the subscription licensing agreement signed between the two, INC Research joins etrials’ CRO partnership programme. This provides partners with a significant competitive advantage by enabling them to offer clients cutting-edge technologies to significantly speed clinical trial research.

As an etrials partner, CROs have access to etrials' eClinical technologies for an annual subscription license fee, which enables effortless integration of all study data for faster and more efficient trials. etrials’ CRO partners offer their clients the technology needed to provide faster access to higher quality data, enabling them to bring important new drugs to market faster.

“At INC Research, we maintain a commitment to integrating innovative solutions into our processes in order to provide the highest quality service to our customers. eClinical technologies like electronic data capture, eDiaries and interactive voice response streamline our data collection, review and reporting processes. This enables our teams to focus on our customers, not the arduous task of integrating multiple data streams or managing disparate technologies,” explained Anne Wiles, president of INC DataSpectrum, the data services division of INC Research.

“By recognising the critical importance of offering fully integrated eClinical technologies, INC Research is able to offer their clients the best tools for their clinical research regardless of trial location, scope or complexity,” said John Cline, ceo of etrials.

In a separate deal, CRO Omnicare Clinical Research has signed a technology transfer deal with etrials to in-license eClinical technology. This alliance will enable Omnicare Clinical Research to develop and manage the electronic case report forms and study databases used by their clients. The agreement will also add further value to Omnicare's offerings by providing clients with faster access to high-quality data while improving their ability to focus on the metrics that drive their high standards of customer service.

In addition, once the technology transfer is complete, Omnicare’s project teams will be able to leverage the internalised technology to quickly and efficiently deploy new studies.

All of etrials’ in-licensing programme clients receive the etrials Designer tool, an easy drag-and-drop environment for quickly creating electronic case report forms while automatically building the backend database. Clients also receive a multi-tier training programme that combines the best in instructor-led training with web-based modules and testing. etrials provides clients with comprehensive technical support for all back-end tools used in building, deploying and testing the technology.

These two most recent alliances build on an earlier agreement signed last year with Quintiles. With offices in over 50 countries, this is one of the world’s largest CROs.

In a collaborative effort designed to increase the speed and efficiency of late-phase clinical research, Quintiles has entered into an arrangement to license etrials' eClinical suite of software and to collaborate to develop technology specifically for use in

peri-approval studies.

As part of the arrangement, etrials will augment its existing eClinical suite by developing a new phase four product offering to take advantage of the valuable data collected in late-stage and

post-approval trials. The new products will combine Quintiles’ expertise in the post-approval market, including certain technology transferred to etrials, and etrials’ own technology.

The three-year licensing agreement provides Quintiles’ clients with etrials’ fully integrated suite of eClinical tools for use in late-phase studies, including electronic data capture; interactive voice response; and reporting/analytic tools. The contract also provides etrials with backlog and ongoing work relating to 10 late-phase clinical trials already in progress that will be supported by etrials.

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