Challenges with Implementation of Decentralised Clinical Trials (DCTs)
What are Decentralised Clinical Trials?
The term ‘Decentralised Clinical Trials (DCTs)’ is a recently introduced terminology in the field of clinical research. DCTs, are also referred to as ‘Patient-Centric Trials’ or ‘Digital Clinical Trials’.
The main objective of DCTs is to make trial conduct more efficient and affordable by introducing technologies and tools to enhance the efficiency, while continuing to adhere to regulations and ensuring compliance to the regulations, ethical principles, study protocol and standard operating procedures.
Technology and unique tools make implementation of DCTs possible.
In a conventional trial setting the trial participants are required to visit the trial sites as per the protocol specified clinic visits, where they undergo the study required assessments, whereas in a DCT setting, they are not required to visit the trial sites for the protocol specified visits. The subject communication, interactions and assessments are carried out via use of technologies and other methods at their homes.
The common technology used in DCT are telemedicine, videoconferencing, health monitoring through wearables and digital devices.
Besides technology, there are other methods that are implemented in a DCT like the Direct to Patients concept. Under this concept the administration of the Investigational Product (IP), blood collections and investigations and safety monitoring are performed at the subject’s home. Also, tool like e-COA (Electronic Clinical Outcome Assessment) and e-PRO (Electronic Patient Reported Outcomes) methods are used for capturing outcomes data electronically, employing technologies such as handheld devices, tablets, or the web to enhance the trial participants, physicians, and caregivers’ engagement seamlessly. The data gets directly reported to the study teams.
What causes the growing popularity of Decentralised Clinical Trials?
The possible implementation of DCT was being discussed and deliberated for a while by the pharmaceutical companies and other stakeholders. It had possible advantages to make the clinical trials more participative and result homogenous representation of ethnicity, race, and disease stage in clinical trials. However, the implementation would have been planned to be gradual. This got accelerated due to the challenges that came up and disrupted the continuity of trials during the Covid pandemic outbreak. The stakeholders adapted to DCT swiftly during those days to keep disruption to a minimum while safeguarding the safety and well-being of the trial participants.
Since then, DCTs could be successfully tested and has now emerged as an alternative strategy which has many advantages, including greater patient flexibility, engagement, and the ability to enrol patients who reside far away from the trial sites, ensuring the participants safety and well-being and ensuring better data quality.
What challenges do we encounter when putting decentralised clinical trials into practice?
When there is shift from routine practice, there are always challenges that come up, so it is critical that these are examined so that they can be overcome to fulfil the objective of harnessing the benefit of DCTs.
Adaption to technology:
Adaptation of Technology is key to making DCT possible. One such methodology is Telemedicine by which there is delivery of clinical information and services remotely through real-time communication between the healthcare professional and patient when they are not physically present with each other.
There are practical challenges around that. Administration of electronic consent, (e-consent) instead of a conventional paper-based consent is a new concept and both caregiver and trial participants are not comfortable adapting to newer methods. There could be issues with the internet connectivity, and most trial participants are not technologically savvy and have difficulty to adapt to such new practices and may not like to participate in trials because of that.
Some subjects prefer in-person interactions and assistance instead of virtual meetings with Investigators and study site staff members.
Use of handheld devices, mobile applications may not always be accepted by the trial participants.
There could be similar challenges concerning other stakeholders, linked to the use of technology.
Data Privacy and Confidentiality
Data privacy and confidentiality issues need to be considered in the process of electronic transfer of personal and protected health information. The platforms used should comply with international and local regulation pertaining to data privacy protection. Restrictive access to such records should be maintained and there should be a mechanism to establish the credibility of the same during audits and regulatory inspections. There should be robust mechanism in place to ensure there is no data leakage and breach leading to misuse.
Usage and Adapting New Tools
e-PRO and e-COA are methods by which symptoms and experiences are electronically sent to site staff directly by the trial participants using mobile device technologies. The trial participants will have to be trained in appropriate use of these tools. If the tools are not used appropriately, it may pose a serious impediment in the way of robustness of the data collected and cause serious impact on the outcomes of the study.
Home Visits
Recent days have seen the emergence of doorstep sample collection for routine check-ups, but it is still relatively new for clinical trials. The availability of healthcare professionals to visit trial participant’s home is available only in well-connected larger cities. Since the smaller towns are poorly connected and lacks infrastructure required for DCT, the exercise to reach out to participant’s home in smaller cities would be challenging.
Moreover, home visit healthcare professionals should be qualified and trained for performing their duties well. They should be trained to ensure regulatory and protocol compliance, while maintaining participant confidentiality. It is crucial to make sure the staff working on these new requirements are reliable and accountable. The Investigators would be comfortable if healthcare professional visiting participants homes are medically qualified, so that the study related assessments are done appropriately. For a country like India, it would be difficult to send medical professionals to the participants’ homes on a regular basis. The home visits aspect of DCT would be difficult to implement and may also work out to be expensive when the medical professionals are required to undertake such additional responsibilities.
Remote Monitoring and Challenges:
DCT also encourages that the trial site monitoring done by monitors could be done remotely. This technique is being followed by the industry for some time now but has its own challenges. The issues concerned with the remote source data verification without having physical access to the patients notes pose a big challenge. All sites do not have the same level of infrastructure to support remote monitoring requirements like electronic medical records system (EMR). Some trial sites do not give access to the Site Monitors to their EMR.
How to overcome these challenges?
It would be necessary to provide participants with a standard reference on DOs and DON’Ts about their rights and data protection and should be trained on the requirements associated with DCTs. The administration of institutions participating in clinical trials, investigators, research personnel, and ethics committee members should be trained and made aware about the nature and requirements for DCTs.
Challenges could be overcome by first implementing the DCT principles to minimal risk studies and ensure the robustness of the methodology before implementing across all studies. To start with a hybrid approach should be implemented and gradually migrate to full DCT functionality.
Specialised vendors to support DCTs should be evaluated before utilising their services. It is essential to work with knowledgeable and committed operational partners. Training, supervision, and proactive risk assessment and management are essential for the successful implementation of DCT.
By critical analysis of the feasibility and pragmatic approach and implementation is key to successful adaptation to the decentralisation approach in clinical trials.