The pharmaceutical industry and contract research organisations (CROs) are increasingly adopting the use of technology to improve the process of clinical research. The drive to develop and adopt eClinical technologies is due to a number of factors, such as the pressure to increase drug research productivity while also reducing costs and the need for improved data quality. eClinical technologies, such as Electronic Data Capture (EDC), Interactive Voice or Web Response (IVR/IWR) Systems, Electronic Patient-Reported Outcomes (ePROs) and Electronic Imaging, provide a range of solutions to address the need for greater efficiency and productivity in the drug development process.
Despite providing a range of benefits, eClinical technologies also pose a number of challenges that need to be addressed before these benefits can be fully realised. A major challenge for CROs is to establish an efficient and effective information technology (IT) infrastructure together with appropriate user support. Once the infrastructure is in place, paper-based processes must be automated and different systems must be integrated and standardised to ensure compatibility. In addition, it is essential to ensure that the system complies with regulatory agency requirements. The increasing use of technology is likely to lead to a number of changes within the CRO industry, such as the way in which individual CROs adapt to and use new technologies and the types of technology led services they can provide to sponsors.
Clinical trial technology
Technology has undergone a revolution in functionality, cost and popularity over the past decade, driven by the widespread availability of the Internet and personal computers. CROs now have to provide sophisticated solutions to meet the evolving expectations of the sponsor, the investigator and the patient, with increasing expectations for real-time access to data and information. These expectations include the optimisation of patient enrolment, reduction of screening failures, minimisation of monitoring costs, adjudication of data in real time for endpoints, assessment of safety data for trends and outliers in real-time and the optimisation of transparency and data access. CROs need to meet these expectations to be able to show real value added benefit.
Clinical practice
The use of technology in clinical research mirrors the changes occurring in clinical practice, with the increasing and widespread use of electronic medical/health records (EMRs/EHRs). The use of EMRs has several benefits for CROs conducting trials: it can greatly accelerate the process of patient recruitment, reach patient groups not previously well represented in studies and make screening for potential subjects faster and more methodical. In addition, EMRs can facilitate access to data from other doctors involved in the patient’s care. The use of EMRs has the additional benefit of making investigators more comfortable working in an electronic environment for data entry and communication, potentially reducing data entry errors in EDC and other systems.
Increasing complexity of clinical research data
‘Designer’ drugs targeted at particular populations and particular subtypes of disease are becoming more popular and this type of development philosophy characterises ‘personalised’ drug development. Personalised drugs are popular with sponsors as they are more likely to be effective, although the potential for safety issues remains. Clinical trials may involve fewer patients but tend to have more complex designs with increased data collection requirements. For example, the growth in targeted therapies has increased the use of wet and imaging biomarkers to identify patients who might benefit from new target receptor molecules or to demonstrate a drug’s effects. These data may originate from various sources, e.g., clinical trial management software (CTMS), EDC, laboratory, bio-analytic, medical imaging and interactive technologies. This can lead to problems with data comparability and compatibility when different methods and standards of data capture and storage are used.
Technology needs of the sponsor
The use of technology is continually advancing in the pharma industry. A decade ago, pharma companies were making their own internal investments in technology and systems. However, the proliferation of multiple systems has led to issues with compatibility. Now, the onus is on CROs to develop technology solutions that can be used across companies and trials. This requirement has been aided by the widespread use of the Internet and global telecommunications. Strategic relationships and personalised medicine have resulted in a desire by sponsors for better value for money, increased efficiency and improved visibility of real-time CRO performance. Additional needs are for real-time visibility of safety data and the provision of internet-based investigator training and communications.
Data standardisation and data handling technology solutions provided by CROs are becoming increasingly important for sponsors. At present, multiple data standards, platforms and databases, often located with different vendors, must be used to access all the available information on a clinical trial. This can lead to problems with data sharing and comparability of trial results, e.g., imaging data – knowing which version of the data is the latest and which database holds the latest version. An integrated technology solution that could provide a single information source would solve such problems. Such a solution would manage and standardise all the study data emanating from multiple sources, including EDC, patient diaries, central laboratories and imaging. Potential benefits include data traceability and quicker access to safety and efficacy data. It could also help to reduce trial costs, in particular by removing the need for re-aggregation of data at the end of a study
ICONIK – ICON’s integrated information platform
ICONIK is ICON’s powerful integrated information platform that consolidates, standardises and visualises operational and clinical data from multiple sources (including CTMS, EDC, IVRS, laboratories, imaging and ePRO) to provide a single holistic view, via a web-based portal, of all study information, from study start-up to database lock. ICONIK can analyse a blend of operational, quality, efficacy and clinical safety data across multiple studies and different therapeutic areas, making it the most effective tool in the industry for the proactive management of a clinical trial.
ICONIK optimises the management and aggregation of clinical trial data in near real time, allowing data to be maintained in a single standardised format, with appropriate controls, providing an auditable chain of custody and the ability to create customised performance metrics. It provides one place to go for all teams for any study-related questions. ICON is the first CRO to incorporate Oracle’s Life Sciences Data Hub in its platform, which provides a fully integrated clinical data environment, with strict version control and full traceability of data processing. ICONIK enables risk based monitoring and adaptive trial design based on the availability of near real-time data collected while the trial is ongoing. In addition, it can have a positive impact on facilitating audit trails, data mining and combating malpractice.
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