Kristin Brooks03.17.14
Among the most sought after ways to reduce the time and costs associated with the conduct of clinical trials, IT solutions are at the top of the list. E-clinical solutions have transformed the realm of clinical research over the years and new capabilities such as analytics technologies and automated systems are constantly evolving, transforming not only the way data is collected but also how it is used. For example, using historical data for new protocol designs and study planning to help reduce uncertainty, and automation that now spans the entire clinical research spectrum, from feasibility through to data submissions of study reports to regulatory agencies.
With a myriad of technologies and solutions to choose from, what do CROs use run their trials and how do they employ these technolgies? We spoke with Raghu Chintala, global head of IT Business Partners at ICON plc. to discuss the latest technology trends in the clinical space, current obstacles, and major advances. --KB
Contract Pharma: What are some of the latest technology trends in the clinical space?
Raghu Chintala: There have been many technology advances in the clinical space. One example is risk based monitoring resulting from advances made in data capture and analytics technologies. These systems are capable of generating reports and alerts that enable the clinical study teams to target problem areas and monitor trends. Since all of the data across all the visits and across all sites is in these systems, new capabilities have been built to enable clinical data analysis with a view of determining potential safety trends, adherence to the protocol specifications, and determining if there are any regional variations in protocol adherence.
Another example is how the increased use of automated systems in the areas of feasibility and study start-up has led to use of historical information stored in these systems to more accurately predict the conduct of future studies. This is especially true in the areas of site initiation timelines in various countries at the indication level. Integration of these systems enables operational metrics reporting and generation of leading indicators of risk associated with milestones, quality and safety thus helping in better project management.
CP: What types of e-clinical/EDC solutions does ICON currently use? (i.e. software as a service (SaaS) vs. applications, analytics software, etc.)
RC: ICON uses a variety of integrated systems for all aspects of clinical trials. These include commercially available and bespoke systems that span electronic data capture, feasibility, start-up, resource management, project planning, and statistical programming. We also use custom developed analytical software for operational and clinical metrics. We use some software in a SaaS model while others are in a traditional licensed software model. In some cases, we use systems that are in the sponsor environment, which are accessed remotely (e.g., sponsor-specific safety databases, sponsor-specific quality management systems).
CP: Do you use a broad overreaching Clinical Trial Management System or multiple applications for trials, clinical trial design, and data capture.
RC: We use a broad CTMS that is integrated with other specialized systems used for specific areas such as feasibility, study start-up, project planning, and resource management. We have different systems that we use for data capture (EDC).
CP: What current obstacles do you look to overcome in the clinical data realm? Are there any areas where inefficiency looms?
RC: In spite of some recent guidance on risk based monitoring from regulatory agencies, sponsors can still insist on 100% of the source data to be verified by the CRAs. This need, combined with the ever increasing pressure to reduce the timelines and costs for studies, presents a challenge in terms of efficient use of CRA time on site. The key is to constantly review the amount of unverified data at each site and proactively guide the CRA to target the visits that need to be verified.
As EDC systems become more sophisticated, edit checks can be built to verify data entry at the site and prevent erroneous transcription of data from the source forms. This reduces the number of queries and makes the process of data capture more efficient.
Currently different systems are used for maintaining the baseline enrolment numbers. The most up to date actual enrolment numbers are typically stored in interactive voice response systems (IVRS). Because of the variety of service providers involved in clinical trials, lack of integration of these systems leads to not being able to generate up to date enrolment numbers.
CP: In what areas do you see major advances?
RC: Historical knowledge on completed studies (e.g., country specific regulatory timelines, indication specific site start-up timelines, screen-fail rates associated with similar studies) is being brought to bear on protocol design and study planning. This is an important area aimed at reducing the uncertainty associated with future studies.
Integration of data across multiple systems (e.g., EDC and CTMS) can provide leading indicators of risk on a study. For example, incomplete SDV and open queries obtained from the EDC tool combined with site monitoring plan in the CTMS can be used to compute the risk associated with database lock for a study.
CP: Do sponsors look to use specific e-clinical/EDC solutions for trials?
RC: Yes. Some sponsors pick a particular system and others leave that choice to the CRO providing the data management service. This is also the case for other systems such as CTMS, quality management, issue tracking, safety database etc.)
CP: How has conducting trials changed in the last three to five years as a result of e-clinical solutions?
RC: The advent of e-clinical solutions has automated many of the manual processes that were in use before and which were sometimes prone to human error. Automation now spans the entire spectrum of clinical studies from feasibility through study conduct to electronic submissions of data and study reports to regulatory agencies. These solutions have led to increased quality of data and reduction in errors in the capture and correlation of the data.
Kristin Brooks has been the associate editor at Contract Pharma since 2004.
With a myriad of technologies and solutions to choose from, what do CROs use run their trials and how do they employ these technolgies? We spoke with Raghu Chintala, global head of IT Business Partners at ICON plc. to discuss the latest technology trends in the clinical space, current obstacles, and major advances. --KB
Contract Pharma: What are some of the latest technology trends in the clinical space?
Raghu Chintala: There have been many technology advances in the clinical space. One example is risk based monitoring resulting from advances made in data capture and analytics technologies. These systems are capable of generating reports and alerts that enable the clinical study teams to target problem areas and monitor trends. Since all of the data across all the visits and across all sites is in these systems, new capabilities have been built to enable clinical data analysis with a view of determining potential safety trends, adherence to the protocol specifications, and determining if there are any regional variations in protocol adherence.
Another example is how the increased use of automated systems in the areas of feasibility and study start-up has led to use of historical information stored in these systems to more accurately predict the conduct of future studies. This is especially true in the areas of site initiation timelines in various countries at the indication level. Integration of these systems enables operational metrics reporting and generation of leading indicators of risk associated with milestones, quality and safety thus helping in better project management.
CP: What types of e-clinical/EDC solutions does ICON currently use? (i.e. software as a service (SaaS) vs. applications, analytics software, etc.)
RC: ICON uses a variety of integrated systems for all aspects of clinical trials. These include commercially available and bespoke systems that span electronic data capture, feasibility, start-up, resource management, project planning, and statistical programming. We also use custom developed analytical software for operational and clinical metrics. We use some software in a SaaS model while others are in a traditional licensed software model. In some cases, we use systems that are in the sponsor environment, which are accessed remotely (e.g., sponsor-specific safety databases, sponsor-specific quality management systems).
CP: Do you use a broad overreaching Clinical Trial Management System or multiple applications for trials, clinical trial design, and data capture.
RC: We use a broad CTMS that is integrated with other specialized systems used for specific areas such as feasibility, study start-up, project planning, and resource management. We have different systems that we use for data capture (EDC).
CP: What current obstacles do you look to overcome in the clinical data realm? Are there any areas where inefficiency looms?
RC: In spite of some recent guidance on risk based monitoring from regulatory agencies, sponsors can still insist on 100% of the source data to be verified by the CRAs. This need, combined with the ever increasing pressure to reduce the timelines and costs for studies, presents a challenge in terms of efficient use of CRA time on site. The key is to constantly review the amount of unverified data at each site and proactively guide the CRA to target the visits that need to be verified.
As EDC systems become more sophisticated, edit checks can be built to verify data entry at the site and prevent erroneous transcription of data from the source forms. This reduces the number of queries and makes the process of data capture more efficient.
Currently different systems are used for maintaining the baseline enrolment numbers. The most up to date actual enrolment numbers are typically stored in interactive voice response systems (IVRS). Because of the variety of service providers involved in clinical trials, lack of integration of these systems leads to not being able to generate up to date enrolment numbers.
CP: In what areas do you see major advances?
RC: Historical knowledge on completed studies (e.g., country specific regulatory timelines, indication specific site start-up timelines, screen-fail rates associated with similar studies) is being brought to bear on protocol design and study planning. This is an important area aimed at reducing the uncertainty associated with future studies.
Integration of data across multiple systems (e.g., EDC and CTMS) can provide leading indicators of risk on a study. For example, incomplete SDV and open queries obtained from the EDC tool combined with site monitoring plan in the CTMS can be used to compute the risk associated with database lock for a study.
CP: Do sponsors look to use specific e-clinical/EDC solutions for trials?
RC: Yes. Some sponsors pick a particular system and others leave that choice to the CRO providing the data management service. This is also the case for other systems such as CTMS, quality management, issue tracking, safety database etc.)
CP: How has conducting trials changed in the last three to five years as a result of e-clinical solutions?
RC: The advent of e-clinical solutions has automated many of the manual processes that were in use before and which were sometimes prone to human error. Automation now spans the entire spectrum of clinical studies from feasibility through study conduct to electronic submissions of data and study reports to regulatory agencies. These solutions have led to increased quality of data and reduction in errors in the capture and correlation of the data.
Kristin Brooks has been the associate editor at Contract Pharma since 2004.