When is it worth carrying out a DDCT?

Digitalisation offers numerous opportunities for complex projects such as clinical investigations. It is advisable to carefully weigh up the opportunities against the costs for the scope and type of digitalisation.

Increasing the efficiency of clinical investigations through the consistent use of digital technologies

• Increased efficiency: speeding up processes by automating manual tasks and improving the flow of data
• Improving data quality and accessibility: digital systems enable data to be captured, stored and analysed more accurately and quickly, which increases the quality and availability of information
• Increased transparency and traceability: digital tools allow all steps of a project to be documented and tracked automatically, if necessary, which increases transparency and can facilitate compliance with regulations
• Better communication and collaboration: digital platforms promote collaboration and the exchange of information between the various stakeholders
• Cost reduction: the automation and optimisation of processes can reduce the costs of clinical investigations
• Extended analysis options: in individual cases, large amounts of data and machine learning can be used to recognise complex data patterns and gain new insights that would be difficult or impossible to discover using traditional methods

Factors that significantly influence the extent of a project's digitalisation

• Technological infrastructure: The availability and quality of the technological infrastructure, including hardware, software and network capacities, at the relevant study participants or trial sites are decisive for the degree of digitalisation that is possible in a clinical study.
• Regulatory framework: Legal and regulatory requirements can influence the implementation of digital solutions. The decisive factor here is the region in which a study is conducted. It also defines the data protection regulations.
• Organisational readiness and culture: The willingness and ability of an organisation, individual stakeholders or a specific target population to integrate digital technologies must be taken into account.
• Proven experience: Experience with and the existence of standard operating procedures (SOPs) in conducting studies with digital technologies and training influences the extent of safe digitalisation
• Competences and training: availability of professionals with the necessary digital competences and willingness for continuous training characterise DDCT stakeholders.
• Security and data protection measures: robust and certified security and data protection measures are necessary to fulfil regulatory requirements.
• Interoperability and standardisation: different digital systems and platforms may need to be seamlessly integrated through processes.

By taking these opportunities and factors into account, the digitalisation of clinical investigations can be driven forward and the associated benefits maximised.

A simple cost-benefit analysis is not the only way to determine when a fully digitalised clinical study is worthwhile for manufacturers. Of course, the general considerations for the digitalisation of projects also apply here.

In general, the potential benefits such as increased efficiency, improved data quality, increased transparency and cost savings outweigh the investment in the necessary digital infrastructure and process reorganisation, taking particular account of the regulatory environment in which clinical studies are conducted.

Factors that speak in favour of complete decentralised digital clinical studies include

• Study size, number of study participants
• Planning of consecutive studies
• Complex questionnaires
• Lack of need for physical examinations
• digital-affine study collective
• Frequent follow-up visits
• Level of experience and processes in trial centres
• high risk due to the investigational medical device, study design or study population
• long study duration
• Special study designs
• High number of study centres, possibly in different countries with different languages
• Tight schedules with sufficient time for preparation
• High regulatory requirements
• Possibility of customising the study protocol
• Integration of digital data via sensors, interfaces to different source data
• supra-regional recruitment.

Ultimately, the decision depends on a careful analysis of the specific study requirements, the available resources and the expected costs and benefits.

Who makes the decision to plan or conduct a fully digital, hybrid or traditional clinical study?

The decision on whether to conduct a fully digitalised clinical investigation should be made by an interdisciplinary team that includes all relevant stakeholders.

The decisive factor is the competent composition, including the sponsor/client of the study, head of the clinical investigation/study physicians, experienced project managers, data managers/biometricians, IT experts/EDC system administrators, regulatory authorities and ethics committees if applicable, data protection officers, patient representatives if applicable.

A collaborative approach involving these key stakeholders allows the advantages and disadvantages of full digitalisation to be assessed holistically and an informed decision to be made. The final decision-making power lies with the sponsor of the study, who also defines the objective and purpose as the controller within the meaning of Regulation (EU) 2016/679 (General Data Protection Regulation).

By taking these opportunities and factors into account, organisations can successfully drive forward the digitalisation of their projects and maximise the associated benefits.

Would you like to know what opportunities a DDCT offers for your clinical investigation? Pleasecontact us for an initial discussion!

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