home > ict > winter 2011 > early learners
International Clinical Trials

Early Learners

Kim Boericke at i3 considers how an early phase oncology study can be optimised and made cheaper through technology and management initiatives

The cost of conducting early phase oncology studies has increased substantially over the last decade, and there are numerous causes that have led to this increase. Protocols are now more complicated, start-up is more demanding with longer timelines and the patients are harder to find. More sites are needed to recruit the patients, and the systems used to capture and analyse the data are very expensive. Faced with all these issues, is there anything that can be done to improve the overall expense incurred by conducting early phase trials?


The first area that can be addressed is the protocol. Current protocols have become very complicated, making them more difficult to implement at the investigative site. The increased number of procedures conducted and data points collected raise sitesí financial outlay, both when conducting the trial and when collecting and analysing the required data. Protocols need to be streamlined to answer specific questions that determine the correct dose needed to progress to the next phase. If streamlined, the protocols will be easier to implement at busy oncology sites and the overall costs at the sites will be reduced.

Secondly, start-up in an oncology trial is a very timeconsuming and resource-demanding process. While process refinements and electronic communication have supported some efficiency improvements, the most dramatic transformation to study start-up of oncology trials is the application of informatics and end-to-end study management technologies. When this data-rich information and new technologies are linked with a data capture system, significant cost reductions and greater trial efficiency can occur.

Start-up timelines continue to be identified as the leading culprit of project delays. These delays are attributed to processes that are still intrinsically manual and project team decisions that are based on qualitative information. Data driven strategies, combining a state-of-the-art clinical trial management platform with data mining capabilities, which utilise a combination of extremely large claims databases and publicly available data resources, can improve the quality of trials while decreasing the overall cost. Utilising the data assets, the patient eligibility criteria of an oncology protocol can be optimised and the patient population can be assessed to determine the most feasible oncology sites to target. Oncology sites with a proven performance record will be identified for the study, and since they have the right target patient population, there is a high probability that patient enrolment timelines can be met. With a targeted approach to site selection based on performance and data, fewer resources will be needed to begin the study.

The project teams are applying this quantitative information and corporate intelligence, including previous performance data, to site selection and start-up procedures. Optimisation at this stage enhances future patient recruitment and site acceptance, keeping start-up on track while reducing the number of protocol amendments. Meanwhile, greater visibility about patient prevalence promotes more meaningful dialogue with sites during selection and start-up. Analytic capabilities are improving patient profile and subject identification algorithms for even the most complicated patient eligibility scenarios. The ability to pre-identify the right potential patients supports a more accurate enrolment forecast based on real data.


The use of better site-management technology and work flows is helping project teams improve the start-up timeline. However, the challenge that still exists is the start-up at the oncology site. With all the additional review committees, which vary from site to site, the approval timelines vary as well. This can add to the overall timeline and cost of the study. Having this information upfront provides additional data that can be utilised to assess the sites during site selection. Additionally, workflow management for contracts and grants can alleviate one of the most common start-up delays, especially at the larger oncology institutions. Armed with the ability to see the contracting workflow and the regulatory document workflow in the same system, the project team is better equipped to achieve the overall start-up timelines that were planned upfront. The ability to manage the entire regulatory document collection and submission process is improved, timelines are decreased, and the maintenance is made easier. The further capability to submit electronic information to the siteís institutional review board supports better regulatory compliance and also can shorten timelines, thus reducing some cost.

New study management technology, which allows for easy connectivity of the entire project team and site, promotes open and transparent communications, easier flow of paperwork, more efficient decision making and better business process management. Additionally, an increased speed in study startup, enrolment and data collection timelines can demonstrate cost savings. Improvement through technology creates better and longer term relationships between project teams and oncology sites. The new clinical trial management systems use intuitive dashboards to deliver real-time access to study information for the sponsor, research team and site staff. Nearly all of the key activities of start-up are enhanced when days are saved with clean work flow between parties. Timeline compliance is improved with clearly delineated tasks and ownership between the project team and sites.


The next focus is around identification and enrolment of patients. Historically, cohort trials develop recruitment projections based on a very short timespan for the recruitment of each cohort. The period could be as short as days or as long as a week, based on qualitative information and the rates that were generated during the last similar study performed. Often, recruitment forecasts underestimate the difficulties the sites will have with enrolling patients. Missing the forecast often results in significant delays in the overall project, since the treatment time and safety-hold periods are defined and cannot be shortened.

Today, informatics is assisting recruitment strategy and tactic development by identifying oncologists with proven performance who have the required patient population. Based on this information, better site support priorities can be planned and more accurate enrolment can be forecast. Sites also can be provided HIPAA-compliant patient information for prospective recruitment; this shortens chart review, decreasing the study staff ís workload and prompting appropriate physician-patient conversations during patient visits to the physicianís office. Likewise, study management technology serves the oncology site that wants to be an active contributor to the programme. Self-service through the technology allows the Phase I sites to have immediate access to enrolment of each cohort and enables oncologists to watch the overall safety profile as data become available. Utilising the dashboards and bulletin boards posted within the system allows the oncology site the opportunity to notify the project team when anything of interest occurs. Oncology sites and project teams will become part of a transparent workflow, which will ensure issues are reconciled more quickly by the appropriate party. Project dashboard views for enrolment and data optimise site support strategies and enhance the study teamís ability to manage each cohort more effectively. With seamless document sharing, travel for the clinical team is reduced while the investigator study file and clinical data quality improves.


The future also will bring the next wave of state-of-the-art technology that will begin to link the clinical trial management tool with an electronic data capture system. The ability to manage a trial from site selection through data analysis will continue to decrease the overall time it takes to conduct a clinical research study. A clinical study will be able to be conducted with high quality, efficiently and cost effectively. With timeline and productivity metrics, project teams can expect to see improved outcomes, better relationships with the sites, and a reduction in the cost of running the trial.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:

There are no comments in regards to this article.

With 20 years of experience in the drug development industry, Kim Boericke has worked for academic research institutions, pharmaceutical companies and clinical research organisations. She has worked on global drug development programmes in all clinical phases, developing strong customer management programmes and managing clinical operations. In her role as i3ís Global Vice President, Start Up, Regulatory Compliance and Strategic Outsourcing, Kimís responsibilities include expediting start up from site/country feasibility through drug release, and developing, managing, and expanding i3ís strategic outsourcing relationships through functional service providers. She has particular expertise in managing drug development programmes through all clinical phases (I-IV), developing strong customer management programmes and managing clinical operations.
Kim Boericke
Print this page
Send to a friend
Privacy statement
News and Press Releases

Jackson ImmunoResearch Announces New Range of Antibodies for Serology and Diagnostics Market

West Grove, PA Ė 02 August 2022: Jackson ImmunoResearch, a manufacturer of secondary antibodies and immunoreagents for the life science market, announces a new addition to its range of products for scientists developing immunoassays for the serology and diagnostics markets. JIR Mouse Monoclonal Anti-Human IgE antibodies are the latest addition to our suite of products suitable for diagnostics research and development.
More info >>

White Papers

Finding the Right End-to-End Safety Solution for Your Needs


With upcoming changes, including the implementation of the International Conference on Harmonisation (ICH) E2B(R3) Electronic Transmission of Individual Case Safety Report and Identification of Medicinal Products (IDMP) standards, the current state of safety reporting can be confusing. Your existing safety system may not be flexible enough to accommodate these changing regulations, which are still moving targets regarding the details needed for a comprehensive solution with the right level of processes, company-to-company integrations and finalized regional rules.
More info >>




©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement