ICON's Technology Solution to Improve the Management of Drug Development Programs
Kris Gustafson • Senior VP Global Data and Technology, ICON Clinical Research
Adrian Pencak • Vice President, Data and Technology Services, ICON Clinical Research
The pharmaceutical industry and contract research organizations (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 realized. 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 standardized 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 technologyled 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 optimization of patient enrolment, reduction of screening failures, minimization of monitoring costs, adjudication of data in real time for endpoints, assessment of safety data for trends and outliers in real-time and the optimization of transparency and data access. CROs need to meet these expectations to be able to show real value added benefit.
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 characterizes 'personalized' drug development. Personalized 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 pharmaceutical industry. A decade ago, pharmaceutical 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 personalized 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 standardization 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 standardize 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
The technology solution – ICONIK
The ICON solution that meets the technology needs of the sponsor is ICONIK, a web-based technology suite that enables the management, reporting, analysis and visualization of all data relating to drug development. ICONIK can collect, manage and standardize study data from multiple sources, including EDC, patient diaries, central laboratories and imaging, to provide a single view of study information. ICONIK is a one-stop, centralized, clinical development work environment for clinical programming teams, providing superior security, access control and chain of custody of not just the data but also the data cleaning, statistical programs and study outputs. Based upon ICONIK's in-built audit trail capabilities, sponsors can be assured of the transparency and integrity of all the data and clinical programming processes. In addition to managing clinical data, ICONIK can collect operational data, such as project management, CTMS and metric information. Investigator data, such as payments, site details and performance, can also be incorporated.
Data transparency and near real-time access to study information, enabling visualization of study data, such as status, progress and trending from study startup to database lock is the core benefit. ICONIK enables quicker access to safety and efficacy data, allows sponsors' simple signal detection to identify any issues and provides a full 'audit trail', which shows who has done what and when. This improves the quality and transparency of the data and the speed at which it is collected. One example of efficiency savings is the provision for creating a standard patient profile. ICONIK makes this a quick and easy process compared with the current system whereby data from many different databases must be collated to produce one patient profile. ICONIK also allows for adaptive trial design whereby a sponsor can adapt a clinical trial 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. For a sponsor, this solution provides a 'one-stop data shop' with web-based access via a single portal. It enables study comparisons, quicker patient enrolment and data lock. Improved quality and speed of data collection will help the sponsor to achieve shorter time to market and lower drug development costs.