How to improve your clinical study management
Clinical trials are an essential means to ensure patients’ safety and drug efficacy. One of the most critical steps of a successful clinical trial is how the trial is designed, planned, and executed.
An emerging trend in clinical trials design is going towards complex trials. Complex trial designs address multiple hypotheses and research questions within one single trial. A further level of complexity is also seen in platform trials, where multiple, simultaneous, and differently timed interventions are compared against a single, constant control group. While such trial designs can accelerate the process from development to drug authorization and also optimize research and development (R&D) spend, it complicates the organization and the execution of trials. Nevertheless, these trials are becoming more and more popular with an increase of 70% of total procedures that are carried out in phase III trials (when comparing clinical trials between 2001 and 2015). Another emerging trend in clinical trials are adaptive trials. In contrast to conventional clinical trials which are static in their protocol and do not permit the modification of any parameters, adaptive clinical trials allow the change of parameters and further continuation of the trial based on interim analyses. Both adaptive and complex trials designs are important instruments for the life sciences industry to speed up their R&D, shorten innovation cycles and enable better patient outcomes..
However, life sciences customers have pointed out that both designs are very challenging to manage for clinical trial managers: requiring a very thorough and reliable planning while allowing sufficient flexibility to adapt trial design based on interim results. Existing software solutions on the market do not adequately meet these requirements. Most clinical trial managers only use highly customized monolithic software solutions that are lacking flexibility in supporting modern trial designs. Additionally, custom software solutions are not always compatible with downstream or upstream solutions such as clinical trial management systems (CTMS), supply planning and production systems which complicates the process even further. Searching for documents or information, switching from one software system to another, or toggling from spreadsheet to spreadsheet leads to manual workarounds, additional workflows and process inefficiencies.
SAP and Tenthpin, together with an industry consortium led by Roche have risen to this challenge and developed an SAP industry standard software solution: SAP Intelligent Clinical Supply Management. The solution consists of several modules covering the whole clinical supply chain: from study management, to planning and forecasting, manufacturing & packaging, distribution and dispensing of the medication to the study subject.
Proceeding with the Study Management module, the current blog series gives an overview of the different modules of SAP Intelligent Clinical Supply Management.
Planning a trial with SAP Intelligent Clinical Supply Management
Based on the challenges highlighted by customers in the industry consortium, SAP has designed and developed a Study Management module integrated with the entire SAP Intelligent Clinical Supply Management solution suite. This module is the first step towards a flexible, integrated, and efficient clinical trial supply management system.
The Study Management module translates the clinical protocol of the trial into a digital format and serves as connection point of the clinical protocol to other SAP Intelligent Clinical Supply Management modules. It can handle many complex trial designs (complex treatment schedule, adaptive trials etc.) and it includes several supply chain parameters, collaboration features and integrates with Clinical Trial Management (CTM) systems or Interactive Response Technology (IRT) systems, thus accelerating study setup and simplifying the life of a clinical trial manager. The Study Management module provides an intuitive user experience and is based on the human-centered design system SAP Fiori.
The following sections highlight the main functionalities that are a part of the Study Management module:
Trial design: complex treatment schedules, adaptive trials
The centerpiece of the Study Management module is a dedicated object to hold all definition data for clinical demand planning. It provides advanced functionality to create, manage, and design clinical studies of differing levels of complexity.
The following parameters can be defined:
- Study Header
Here, all basic information about the study can be entered, such as study description, study status, sponsor, lead molecule, phase, and therapeutic area.
- Study Contacts
The contacts represent key staff assigned to the trial supply chain of a study, such as trial manager, supply manager, and other configurable entries based on the individual needs of the study.
- Site Groups
Site groups can represent individual countries, groups of countries or regions inside a country, depending on customer requirements. Suitable lists of site groups for a study can be selected, and site groups can be flexibly added at a later stage, allowing also the planning of adaptive trials.
It is also possible to assign central, regional or local distribution depots to the site groups. If desired, delivery lead times to be considered in the whole process can also be maintained. This enables customers to also manage complicated manufacturing and distribution scenarios for the different study sites.
- Blinding Groups
Blinding groups are structures to hold different materials blinded together under one blinded description. Blinding groups are then used in the Kit Type design.
- Kit Design
This function allows to combine blinding groups, label groups, site groups and materials. Thereby blinded or open label kit types can be defined for different country combinations to plan label content for clinical finished goods. This gives customers the ultimate flexibility that is needed to organize complex clinical trials.
- Study Types
The Study Management module also provides a built-in support for various study types like titration, dose-escalation, adaptive and platform trials, while ensuring integration with material master data in SAP S/4HANA.
- Treatment Schedules
A treatment schedule defines visit and dispensing events for subjects participating in a study by treatment group. In a treatment schedule, the expected dropout rate and any switches between treatment groups can be defined. It is also possible to define dispensing and non-dispensing periods and to assign treatments, even by directly linking them to the kit type.
To gain a better overview of the trial, treatment schedules can also be visualized.
With its overall flexibility and the comprehensive collection of study parameters, the Study Management module is made to support complex treatment schedules and adaptive trials. The structure of a clinical trial can be defined and customized based on any of the parameters mentioned above: on kit types, blinding groups, randomization and treatment groups, and treatment schedules. It is also possible to define multiple scenarios for a trial, for example with different enrollment curves, for demand planning purposes.
To support the smooth collaboration and interaction of different users, the Study Management module contains several features that enable users to communicate with each other directly in the system. If required, users can write a comment on a study they have created and can also tag colleagues in the comment itself so that they get informed directly. And if it is necessary to track changes to certain parameters in a study, users can view the change history (Change Log) with information about who has made which change and when this happened.
Compare Studies with CTMS repository
An important aspect for clinical supply planning is the alignment with clinical operations and existing Clinical Trial Management Systems (CTMS). Therefore, the Study Management module contains a dedicated app to integrate and quickly identify differences between the study data in the study protocol and data in the CTMS repository. If needed, changes can directly be incorporated into the Study Management module. It is also possible to sync the study to the repository in its entirety or just to specific attributes that shall be incorporated which prevents clinical trial managers from working with different data sets in different systems and helps to streamline the planning of the clinical trial right from the start.
Study Management module at a glance
Taken together, the Study Management module serves as a starting point for planning and implementing a cost-effective and well-executed clinical trial with SAP Intelligent Clinical Supply Management. It supports advanced and dynamic trial designs (such as adaptive and complex studies) with flexible and configurable clinical study set up. Its connections to CTMS supersede failure-prone manual interfaces. Thus, it is the foundation for the execution of end-to-end process operations to plan, source, manufacture, distribute, and reconcile supplies for clinical research and development.
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This article is the second part of a five-part blog series on SAP Intelligent Clinical Supply Management. The first part of this series was already published some weeks ago. Please be invited to follow the tag “SAP Intelligent Clinical Supply Management” to not miss any of the future articles posted on this topic. We are also happy to receive your feedback, questions or thoughts in a comment.