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International Clinical Trials

Lines of Communication

Christophe Golenvaux at Lambda-Plus discusses the value of optimising the workflow between medical imaging and clinical trial e-platforms by streamlining the interaction of the two fields

Over the past decade, medical imaging has played an increasingly large role in diagnosing diseases and assessing new drug candidates. The use of endpoints depending on the results of imaging tests in clinical trials of therapeutic drugs and biological products is now a priority for the FDA. Parallel to this, e-platforms designed to support all phases of clinical trials and accessed by everybody involved in a study have become far more widely available. These e-platforms do not specifically focus on investigators using electronic data capture to collect patient data, but are also accessed by a wide range of users, such as CRAs, monitors, project managers, and pharmacovigilance staff, to improve interaction between them.

Given the growing pressure on the pharmaceutical and biotechnological industries to continue to improve processes at every level of clinical development, and a greater awareness that systems should ‘talk to each other’ to improve the efficiency of clinical trials, there is a real need to implement a streamlined approach in order to guarantee the seamless interaction of medical imaging with clinical trial e-platforms.

CHALLENGES OF MEDICAL IMAGING

The major challenges of medical imaging include gathering images and making sure that investigators are implementing standardised radiological processes scrupulously to obtain the images. The primary method used to transmit clinical trial images is to physically deliver them to an imaging data repository for review. Burning images and physically posting the CD to a repository for further evaluation is an expensive and time-consuming process that may have a significant impact on the productivity and compliance of the sites where investigators are working and their ability to provide robust, accurate and ‘on time’ patient imaging data. More and more investigation sites now have the ability to submit the images to a medical imaging system electronically rather than burning them on to a CD and sending them by courier. Sponsors and other parties involved in clinical trials have discovered that the value of electronic image submission is not exclusively in the cost reduction in terms of transport, but also in the reduction of submission errors and the adoption of an appropriate process for anonymising images.

E-PLATFORMS TO SUPPORT CLINICAL TRIALS

E-platforms help to streamline the process of collecting and exchanging data thanks to a secure single point of access for capturing, gathering, consulting, sharing and tracking all study data.

Clinical trials rely on many different sources of data, which can either be captured immediately in eCRF or imported from other data sources (see Figure 1). Clinical trial e-platforms can therefore act as a central point of access from which to import data for:

  • Central labs: once samples are analysed data is uploaded securely by the lab or ‘pushed’ to the clinical trial database through web services
  • Warehouses (drug supply units): providing a close link between online randomisation (IWRS) and drug supply management for automated re-ordering and uploading shipment information through the same e-platform
  • ePROs: data captured by patients (at home or on-site) using electronic patient reported outcome devices are synchronised with the clinical trial database for further monitoring and reporting
  • Medical imaging: images are sent to the medical imaging system, for example an imaging core lab or a repository where a panel of reviewers-experts can access patient images securely for further interaction with clinical trial e-platforms

E-platforms are not just about collecting data, as they can be used to build a complete logical sequence of the data collected. With an e-platform, any user can access tools that were designed for his/her profile, for example CRAs will track the availability of images, access eCRF data, view the audit trail and raise and follow up queries, while project managers can give the green light for the re-supply of drugs and access real-time dashboards showing the progress of a study. By predefining ‘who is allowed to do what’ and ‘who is allowed to view what’, e-platforms will ensure more effective interaction between everyone involved in a clinical trial and data sources.

MEDICAL IMAGING & E-PLATFORMS: EIGHT STEPS FOR SUCCESSFUL INTERACTION

Although the electronic transfer of medical images solves many issues, it is effective interaction with e-platforms that will provide those involved in a clinical trial with value-added control over the infrastructure and associated workflow resulting in an enhanced reconciliation process and quicker database lock.

Optimised interaction of medical imaging with e-Platforms requires a very close relationship between the e-platform vendor and the medical imaging system in the setup stages to make sure that all steps are taken in the correct sequence. Figure 2 illustrates this concept and highlights eight steps that lead to a workflow supporting the ultimate interaction between the two fields:

  1. The investigator accesses the e-platform to set up a (possibly randomised) patient follow-up: at predefined time points, imaging requests are generated by the e-platform according to study-specific conditions
  2. Requests are sent by email to the radiologist associated with the investigator concerned, and relevant patient and appointment identification codes are associated with each request
  3. The radiologist uploads an image or images onto the medical imaging system
  4. Once the images are quality-controlled and anonymised by the person responsible for managing images – for example, technicians and readers able to assess the relevance and quality of images – a notification is sent to the e-platform
  5. The e-platform generates an automated email notification to readers involved in the evaluation of images. Readers are alerted according to a predefined logic sequence, for example they may be alerted simultaneously or ‘in cascade’, which would include reader one, then reader two and finally the adjudicator
  6. The email contains a hyperlink to the medical imaging system so that readers and the adjudicator can easily take measurements and give their feedback
  7. Once feedback has been given, the medical imaging system generates a masking code (guaranteeing the uniqueness of the event), associates it with the evaluation information as well as with the patient/visit/ reader ID and sends this information electronically to the e-platform
  8. Online reports are then generated and accessed by authorised users, for example if readers are allowed access to patient data, they can view eCRF data as well as their previous feedback for further evaluation. Other dashboards can also be accessed by study monitors and sponsors through the same e-platform to give realtime insight into study progress

There is a real need to implement a streamlined approach for seamless interaction of medical imaging with clinical trial e-platforms so that systems ‘talk to each other’ and thus improve the workflow and productivity of a clinical trial.

CONCLUSION

Today, e-platforms provide excellent interaction with medical imaging and are customised according to study-specific clinical trial protocols: the involvement of everyone working on a study ensures that anyone can have access to the tools and associated information in the best conditions. Optimised interaction does, however, require a very close relationship between the e-platforms and medical imaging vendors in the setup phase. In the very near future, e-platforms will be even more interactive; with more and more e-platforms providing those involved in clinical trials with value-added control over the infrastructure and associated workflow leading to an improved reconciliation process, quicker database lock and significant cost reductions thanks to the deployment of fully integrated systems, streamlining the clinical research process.

Further Reading

CDER, Guidance for Industry Standards for Clinical Trial Imaging Endpoints-Draft, August 2011


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Christophe Golenvaux is Director of Sales and Marketing at Lambda-Plus, where he has been a member of the board for 12 years. He has 23 years of experience in sales and marketing, and over the last 10 has worked on the promotion and support of user-friendly and cost-effective EDC solutions. In the last decade he has promoted e-platforms that meet each study-specific requirement. Email: christophe.golenvaux@lambdaplus.com

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