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International Clinical Trials

Death of CTMS?

Every few years, we hear or read opinions that the clinical trial management system (CTMS) will soon no longer be required. At the same time, calls are often made to solution vendors to extend the capabilities of core applications such as electronic data capture (EDC) to maintain and report on additional non-clinical data.

More recently, as the clinical development community has edged towards risk-based monitoring, there has been renewed speculation that the CTMS is out of time, since it is assumed that EDC can deliver this capability. This has been encouraged by draft and now final guidance from the US Food and Drug Administration (FDA), a European Medicines Agency reflection paper, an eClinical Forum best practices paper and a recent TransCelerate position paper (1-4).

However, looking at the core functions of the clinical operations team and the common phases of a trial, a strong counter-argument can be put forward that the potential death of CTMS has been greatly exaggerated – in fact, never has a powerful and fully integrated CTMS solution been more important.

Study Proposal

When comparing CTMS with EDC, the breakdown in functionality offered within each system depends on whether the associated data and metadata is clinical or operational. This becomes clear when the lifecycle of a study is considered.

Long before the electronic case report form is conceived or designed, studies will be proposed internally or initiated by the investigator. Each proposal will be tracked and a decision will be taken on whether to pursue the trial. Key activities include:

● Study concept review and approval

● Budget allocation

● Essential document collection

● Drug identification and allocation

A CTMS that extends functionality to study proposal tracking is ideal for this phase, particularly when elements from proposals are used within study planning. In this way, a seamless transition between phases is enabled, with full visibility by senior management.

Based on its purpose and design, EDC is incapable of fulfilling this need. A common alternative might be the use of Microsoft Excel spreadsheets, but this comes with inherent version control issues and lack of validation.

The adoption of applications like SharePoint for study proposal management and tracking has also been seen. While this satisfies the desire for central access and overcomes version control issues, the transfer of data and documents to the next phase requires significant configuration and support to meet a study proposal’s wide and complex requirements.

Once a study is approved, a larger programme and team becomes involved, further necessitating the need for a central management tool.

Tracking Activities

Clinical trials are increasingly complex, with many interdependent tasks requiring careful planning across multiple departments, geographies and organisations. A well-planned study has a much better chance of starting and finishing on time, within budget and with a successful outcome. Key activities include:

● Study team assembled; roles and responsibilities confirmed

● Planning activities identified and assigned/project plans created

● Study feasibility questionnaires developed and performed

● Investigator brochure updated

● Vendor/contract research organisation (CRO) contacted, assessed and selected

● Study team training scheduled and conducted

● Protocol authoring completed

A CTMS is ideally suited to track the status of each of these activities, and many tasks such as project, task and resource planning can be accomplished easily and efficiently. A seamless interface with study set-up and conduct phases can be easily established through a CTMS, as can roll-up across a programme, or for CROs, roll-up for a set of studies for a specific customer, function or geography.

Integrated Technology

Increasing budgetary and time-to-market constraints have put pressure on study managers to move rapidly through the study set-up phase. Well-integrated CTMS technology can provide centralised tracking of activities, document collection and even contract negotiation (see Table 1).

While ancillary applications are often used to fulfil some of these tasks, there is enormous benefit in centralised status visualisation. Furthermore, some CTMS solutions expand their reach either through modules to address specific tasks, or through tight integration with a small subset of applications such as portals for online investigator meeting and contract negotiation.

Programme Management

During study conduct, EDC, interactive web response services (IWRS) or randomisation and trial supply management (RTSM), and electronic patient-reported outcomes (ePRO) come into their own in the collection and even tracking of clinical and logistical data. But CTMS still has a significant role to play here in clinical trial or programme-level management, as illustrated in the subset of study conduct tasks in Table 2 on page 18.

Throughout the study conduct phase and beyond, data is cleaned, reviewed, coded and locked in EDC or a clinical data management system (CDMS) and other tools, including SAS. Datasets are then extracted on which analyses are performed. However, a CTMS can be used effectively as a cross-functional tool to track, manage and record a status of tasks so that downstream activities can be planned. Data and metadata from EDC can then be transmitted to a CTMS to enable site-, country- and study-level analytics and event-based monitoring.

Study Closeout

Closeout is often the most arduous phase of the study since the data has been collected, indicating its objectives have been met. Typical milestones include:

● All project-related activities completed

● End-of-trial notifications submitted to – Regulatory authorities – Institutional review boards (IRBs) and independent ethics commitees (IECs), as required

● Study team closure/lessons learned meeting

● Study results published, including to clinicaltrials.gov

● Site data provided to principal investigator for archival

Again, while other systems may be used to perform many of these activities, their interface with a CTMS is important so that status can be tracked and visualised by management. If a CTMS provides functionality that can be extended to modules, such as for trial disclosure, then even these interfaces are not required and the power of CTMS becomes even greater.

Full-Study Lifecycle

A CTMS is much more than a system to simply track activities and milestones. When used properly, it can guide the sponsor through the complexities of clinical research, ensuring all necessary tasks and activities are planned and completed on time with adequate levels of resource in specific locations.

The use of EDC, IWRS/RTSM and ePRO is becoming more and more embedded. With data immediately available from study sites, it is easy to quantify the reduced effort and time savings from query resolution to database lock. These time savings can be measured in weeks or months. However, clinical trials are not conducted in weeks or months; many are measured in years, and only begin after meticulous planning.

Next Generation

Without question, CTMS has earned a less-than-stellar reputation. In the past, these solutions have taken years to deploy at huge expense, and have never met with the acceptance of study teams. They have been imposed upon study teams by management.

Clearly, this is not the way it should be. A CTMS should be at the centre of a study team’s activity, guiding them through the trial and helping the executive team to understand the progress being made. It should facilitate compliance and help reduce costs by controlling all trial aspects, including project management, resource management and site monitoring.

If all the preparation and activities that are required in the conduct of a study are considered, it becomes premature to forecast the death of the CTMS. But what is needed is a new generation of CTMS that will simplify clinical research and facilitate effective, efficient clinical trials.

References

1. FDA, Guidance for industry oversight of clinical investigations – A risk-based approach to monitoring. Visit: www.fda.gov/downloads/ drugs/guidancecomplianceregulatoryinformation/guidances/ ucm269919.pdf (accessed 10th August 2013)

2. EMA, Refl ection paper on risk based quality management in clinical trials. Visit: www.ema.europa.eu/docs/en_GB/document_ library/Scientifi c_guideline/2011/08/WC500110059.pdf (accessed 10th January 2013)

3. eClinical Forum, Best practices for ensuring clinical data quality. Visit: www.eclinicalforum.org/en-us/downloads.aspx (accessed 18th September 2014)

4. TransCelerate Biopharma Inc, Position paper: Risk-based monitoring methodology. Visit: www.transceleratebiopharmainc. org/content/risk-based-monitoring-methodology-position-paper (accessed 28th June 2013)


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Simon Wilson is a Clinical Subject Matter Expert at ArisGlobal. Simon started his career in clinical research at a site and lab level before progressing though data management, clinical operations, clinical technology and process implementation leadership posts at Bayer, PAREXEL and CSL. He has more than 15 years of experience in head office and affiliate pharma and CRO settings. Simon has a keen interest and expertise in unlocking the potential of eClinical applications.
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