Resistance to Change Affects eClinical Trials Technology Uptake

There has been a paradigm 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 transitioning from paper-based to electronic processes, revenues in the eClinical trials (eCT) market are expected to increase from approximately $210 million in 2004 to $357.4 million in 2011.

However, 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 Frost & Sullivan (healthcare.frost.com 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 all teams within 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 Mr. 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) – such as the recent collaboration between eTrials and Quintiles – also reflect the increasing adoption of these tools in drug development.

"These developments are likely to increase the confidence levels of organisations that are yet to decide on the feasibility of eClinical trials," says Mr. Chitta. "They also reveal the compelling need for CROs or pharmaceutical companies to adopt a single technological platform to realise the benefits of doing most of the drug development process electronically."

If you are interested in a virtual brochure, which provides manufacturers, end-users, and other industry participants an overview of the latest analysis of the World eClinical Trials Market (B726-52), then send an e-mail to Radhika Menon Theodore, Corporate Communications, at rmtheodore@frost.com with the following information: your full name, company name, title, telephone number, fax number and e-mail address. Upon receipt of the above information, an overview will be sent to you via e-mail.