Which are the current methods/ technologies in use for data management in the clinical trial sector?
| Denzil Benjamin |
The contract research industry is increasingly adopting the use of technology to improve the process of data management. 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.
In what way would EDC fill the gap that seems to exist in current forms of data management?
The use of EDC opened the door to real time data processing, which has gained almost universal acceptance as the optimal way to collect and process data. The recent technology developments that enable rapid pooling of data across different data repositories coupled with the advances in portal technology have really revolutionised clinical drug development by making that same data available in an easy to understand manner so that decisions can be taken almost in real-time. This is now the ultimate goal of pharmaceutical companies – rapid access to data to enable real time decision making in order to shorten drug development timelines.
What are the India specific challenges as far as data management in the clinical trial industry is concerned?
I think the multiple data standards, platforms and databases with different vendors are the challenges for data management not only in India but globally. 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. However, we believe the introduction of an information platform such as ICON’s ICONIK has the capability to overcome many of these challenges by standardising the data received and enabling the sponsor and CRO to have visibility of real time information across studies and programmes regardless of the type of source data.
What are ICON’s solutions in the field of data management?
The ICON solution that meets the technology needs of the sponsor is ICONIK, a web-based information platform that enables the management, reporting, analysis and visualisation of all data relating to drug development. ICONIK can collect, manage and standardise study data from multiple sources, including EDC, patient diaries, central laboratories and imaging, to provide a single view of study information. ICONIK is a centralised, clinical development work environment for clinical programme teams, providing superior security, access control and chain of custody of not just the data but also the data cleaning, statistical programmes and study outputs. With 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.
How are your solutions different from your competitors?
Data transparency and near real-time access to study information, enabling visualisation 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 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
What are the factors in the Indian market that you think would help ICON to propel its growth in this part of the world?
Significantly lower operating costs than those typical of western countries and the relatively easy availability of patient and gene pools have facilitated a range of trials in India. The growth of the sector has also been driven by good medical expertise, an English-speaking work force, advanced capabilities in technology and a modern hospital infrastructure. Its world-class laws on intellectual property rights have also boosted industry confidence. India’s status as one of the first countries in the Asia-Pacific region to start a clinical trials registry (it is now mandatory to record all trials in the ‘central registry’ in India) has led to improved transparency and public accountability. Indian data is also accepted by the US FDA for drug approvals. Culturally, India has demonstrated strong doctor–patient relationships, with good treatment of and follow-up care for patients.
India is an important region for ICON, with staff strength of more than 850 employees across its offices in Bangalore, Chennai and Thiruvananthapuram. ICON has tapped into the local talent pool in areas such as SAS programming and biostatistics as well as providing back-end services in interactive technologies, medical safety services, data management and study feasibility assessment. ICON will continue to grow in providing these services out of India for the global market.
Can you tell us about your future plans for the Indian as well as global markets?
At a regional and country specific level, ICON India will continue to invest and grow our staff to ensure we are meeting our customers’ requirements. We will listen to our customers and their clinical development needs and how we can, as their CRO partner work together to support their goals.
For the global markets, operating under strategic partnership models continues to be one of ICON’s strengths. For example, in 2011, ICON announced strategic partnerships with Pfizer and Shire Pharmaceuticals and extended its Bristol-Myers Squibb partnership to incorporate early phase services.
ICON is building unparalleled informatics capabilities which provide full transparency of trial data and enable better and faster decision making while reducing costs. ICONIK, ICON’s integrated information platform, is being very well-received by strategic clients and is a real differentiator for ICON. ICON’s Firecrest investigator site support platform and Medical Imaging capabilities are also good examples of technology solutions where ICON leads the market.
ICON also continuously looks for suitable acquisitions or alliances that can either broaden the company’s service portfolio or add greater depth and scale to existing services. Asia Pacific is an increasingly important market and we plan to build our capabilities through acquisitions or alliances with key players in the region combined with organic growth. For example, our alliance with ACRONET allows us to tap in to their extensive coverage and knowledge of Japan. While an example of strengthening our capability in Asia Pacific through acquisition is the acquisition of BeijingWits, which has strengthened our presence and service capabilities in China.