Additional risk management for digital decentralised clinical investigations or studies with medical devices

The conduct of clinical studies has changed significantly through the use of digital technologies.

Fully digitised clinical studies offer numerous advantages, such as improved data integrity, more efficient processes and error prevention. They are particularly well suited to telemedicine, digital health or care applications (DiGA or DiPA), rare diseases, recording endpoints in the home or for people with limited mobility.

Nevertheless, there are also specific problems and risks that need to be taken into account in addition to the already relevant laws and guidelines for clinical investigations or studies.

Problems and risks associated with completely digital clinical studies

Regulation (EU) 2017/745 (MDR), Regulation (EU) 2017/746 (IVDR), the Medical Device Law Implementation Act (MPDG), ISO 14155:2021-05 and the EMA guidelines, in particular EMA/INS/GCP/856758/2018 and EMA/INS/GCP/112288/2023, guidelines of the Medical Device Coordination Group (MDCG), in addition to other international or national guidelines, provide a framework for addressing these challenges.

Below you will find an overview of aspects that should be considered in a clinical study, which can be conducted in parts, as a hybrid or as a completely digital clinical study (DDCT-MED®), as part of a profound risk management.

Specific risks in the digitalisation of clinical studies‍

1. data integrity and security

• Data loss and corruption: Digital systems are susceptible to technical failures that can lead to data loss or corruption. This can jeopardise the integrity of study results.
• Cybersecurity threats: Clinical data is an attractive objective for cyberattacks. Inadequate security measures can lead to data leaks and unauthorised access, compromising the confidentiality, availability, authenticity and integrity of data.

2 System validation and maintenance

• Validation: The EMA guidelines emphasise the need for validation of computerised systems to ensure that they are reliable and accurate. Inadequate validation can lead to erroneous data and unreliable results.
• Maintenance and updates: Regular maintenance and updates of the systems are necessary to ensure their functionality and safety. These should be done in such a way that they do not lead to interruptions in the study process.

3 Regulatory compliance

• Regulatory compliance: Compliance with regulatory requirements is complex and requires comprehensive documentation and evidence. Without these, a clinical investigation will not be approved by the authorities or may be cancelled. For clinical investigations within the framework of DDCT-MED® or as hybrid studies, action must be taken in accordance with regulations, laws and guidelines from other comparable areas.
• Principles and key concepts: The basic principles of the EMA requirements must be implemented for all computerised systems in clinical investigations and studies in order to protect patients and the overall success of such a project.‍

4 Data management and archiving

• Long-term archiving: The regular and long-term archiving of digital static and dynamic data must ensure that the data is accessible and readable at all times during the study and even after many years. This requires robust archiving strategies and regular reviews.
• Data integration and migration: When integrating data from different source data and later migrating data to new systems, there is a risk of data loss or alteration. Careful planning and validation of the migration are essential.

5 Employee training and competence

• Education and training: All employees must be regularly educated and trained to ensure that they can use the digital systems correctly and efficiently. Inadequate training can lead to operating errors, data problems and crisis situations.
• Proof of competence: The EMA guidelines require that training courses are documented and that the additional competences of employees required for this type of study are regularly reviewed.

6 Patient recruitment and management

• Digital barriers: Not all study participants have access to or are familiar with digital technologies. In principle, this can make the recruitment and retention of study participants more difficult. Technical support must be provided by the staff of the digital study centre (DTC-MED®) as required.
• Data protection concerns: Concerns of study participants and supervisory authorities must be addressed in such a way that all rights of data subjects are protected in accordance with Regulation (EU) 2016/679 (GDPR, DSGVO), as highly sensitive data in particular is also collected and processed.

More opportunities through digitalisation if they are at least as good as "conventional" solutions

The implementation of fully digitised clinical studies offers many advantages, but also brings specific challenges and risks.

Careful planning, comprehensive validation of systems, regular training and strict adherence to regulatory requirements are crucial to minimise these risks and ensure the integrity of study results.

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(as of spring 2024)