7. Decentralized Clinical Trials

7.1 Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)?

The use of DCT elements may be considered on a case-by-case basis.

The Department of Health is embracing innovation, and within their standard medical care, they are applying many decentralized elements. However, there is currently no published policy/guideline or standard specific to the use of decentralized elements in clinical research.

7.2 Is there any specific regulation/guidance on the use of DCT elements within a clinical trial?

The Department of Health is embracing innovation, and within their standard medical care, they are applying many decentralized elements. However, there is currently no published policy/guideline or standard specific to the use of decentralized elements in clinical research.

In September 2020, the DOH published the “DOH Policy on Digital Health” in which one of the key objectives is to “Enforce regulation on safe and ethical research and development”. The strategy of the DOH under this objective is:

“Strategy 9: Establish regulations and processes for any research with and on digital health seeking approval and permission. 

6.3.3. DOH shall: 6.3.3.1. Develop SOPs and regulations for applicable types of research on digital health and/or utilizing digital health technologies. 

6.3.3.2. Determine whether back-office resources and app developers require Institutional Review Board (IRB) approval for digital health technologies to be used in the aforementioned research. 

6.3.4. All healthcare entities shall: 6.3.4.1. Comply with established regulations.”

There are decentralized elements such as telemedicine, mobile nurses, and eConsent that apply to the standard healthcare system.

Given the current landscape, it is advisable for Sponsors intending to conduct clinical trials in Abu Dhabi with decentralized elements to engage with the planned participating sites, local ethics committees, and the Department of Health prior to submissions.

In the upcoming sections, we will present general recommendations from other regulatory authorities, which can serve as valuable considerations when incorporating decentralized elements into a study protocol, and when applicable we will list the existing local guidance/standards available in Abu Dhabi, even if those are not specific for clinical trials.

7.3 What is the overall acceptability of DCT elements by the Regulatory Authority and Ethics Committees?

This may be considered on a case-by-case basis.

The Department of Health is embracing innovation, and within their standard medical care, they are applying many decentralized elements. However, there is currently no published policy/guideline or standard specific to the use of decentralized elements in clinical research.

7.4 Has a fully virtual trial (DCT) been conducted in the country yet? If so, please provide an example including the registration number and any link to it, whether COVID/non-COVID trials.

From the research conducted, information on fully virtual trials (DCT) conducted in the country could not be found.

7.5 Are there any non-regulatory DCT initiatives in the country, such as where the investigator sites and local CROs founded an alliance?

Mergers and acquisitions and strategic engagement between healthcare stakeholders and public and private entities have occurred in the UAE, with a focus on developing the healthcare sector, specifically the Abu Dhabi Vision 2030.

According to an article published by Pharmaceutical Technology, “The public health provider Abu Dhabi Health Services Company (SEHA) partners with healthcare leaders from around the world including John Hopkins Medicine International and Mayo Clinic and collaborates with healthcare professional and innovators to support the development of creative ideas and understand future trends.”

7.6 Are there any general considerations when using DCT elements in a study?

We recommend that Sponsors wishing to conduct a clinical trial with DCT elements in Abu Dhabi take into consideration the general recommendations available from other countries/regions, such as the EMA “Recommendation paper on decentralized elements in clinical trials.”

Sponsors must make sure that the study design and the DCT elements are fit for purpose, taking into consideration the intended population and the safety profile of the study drug, and ensuring appropriate risk management is applied.

Sponsors must provide to the authorities clarity, risks and benefits of using DCT elements in a study, demonstrating how participant safety (data and physical) and well-being are guaranteed, how GCP standards will be upheld, and how compliance with data privacy requirements (GDPR) will be maintained. 

When considering a DCT/hybrid study, it must be ensured that the Sponsor and investigator are able to keep oversight of trial participant safety and well-being.

Oversight: 

• Providing clear roles and responsibilities.
• Documenting which tasks are conducted: where, when, and by whom and how oversight is maintained.
• Clear communication plan between the different parties involved: Sponsor, investigator, participants, and service providers.
• Trial participants informed on information flow, and how to make contact with acute safety concerns/events, device malfunctions, and other questions.
• Training of participants and study staff in the use of any electronic platforms or devices to be used within the study.

It is important to conduct a trial-specific risk-benefit assessment when proposing a decentralized clinical trial (DCT). This assessment evaluates whether the proposed elements are suitable for the participant populations involved in the trial. Regulators typically expect this assessment to ensure participant’s safety and data integrity.

7.7 Considerations/Requirements for the Use of eConsent/Remote Consent

The HAAD “Guidelines for Patient Consent” contains provisions on electronic consent applicable under the Telemedicine interventions section. However, the current Tele-Medicine Standards available are applicable to standard medical care and not clinical research.

The Department of Health is embracing innovation, and electronic consent may be one of the decentralized elements that may be considered during a clinical trial. However, this is not currently supported under any published policy/guideline or standard applicable to clinical research.

We recommend discussion with the DOH if eConsent and eSignatures are planned to be used in a clinical trial in Abu Dhabi.

7.8 Considerations/Requirements for the Use of eSignatures

The HAAD “Guidelines for Patient Consent” contains provisions on electronic consent applicable under the Telemedicine interventions section. However, the current Tele-Medicine Standards available are applicable to standard medical care and not clinical research.

The Department of Health is embracing innovation, and electronic consent may be one of the decentralized elements that may be considered during a clinical trial. However, this is not currently supported under any published policy/guideline or standard applicable to clinical research.

We recommend discussion with the DOH if eConsent and eSignatures are planned to be used in a clinical trial in Abu Dhabi.

7.9 Considerations/Requirements for Electronic Patient Reported Outcome (ePRO)

The use of ePROs is not addressed in the existing policy or guidance on clinical research, however, the Abu Dhabi DOH and ethics committee may accept the use of ePROs within clinical trials. 

The Department of Health, published in June 2023 the “Guidelines on Real-world Data/real-world Evidence-based Clinical Research”. This guideline contains provisions on data capture requirements, including data linkage and synthesis when using mobile-application questionnaires among others. The requirement is for the study protocol to describe the methods of data collection and methods of integrating the collected data with the electronic health care data.

7.10 Considerations/Requirements for Home Health Care (HHC)- Home Nursing

In August 2021, the DOH issued “Standards for Home Healthcare Services in the Emirate of Abu Dhabi”. It is important to highlight that the scope of this standard does not fall within clinical research; however, it provides specifications and requirements that should be taken into account if HHC is planned to be included in a clinical trial, such as:

• Home Health Care Providers and Healthcare facilities must be licensed by the DOH to provide skilled health services at home.
• Adequate training of the health staff. 
• Healthcare professionals involved in the provision of Healthcare services in the patient’s home must restrict their practice to what is permitted by the job description and privilege granted by the employing facility.

It is advisable to discuss in advance with the DOH if HHC is planned to be provided within a clinical trial.

7.11 Considerations/Requirements for HHC - Home Lab Collection

General consideration for Home Lab collection:

Collection of biological samples at home may be permitted, as long as the procedures involved do not cause any additional risk to trial participants or to the reliability of the data, and the person performing the task is qualified and/or trained to perform the task. If biological samples are collected at home, it should be considered whether persons taking the sample are qualified and allowed by their local legislation to take the sample. In addition, adequate handling and storage conditions for the samples throughout the entire process should be assured.

There may be additional requirements and training at the country level for handling infections and biological material.

It is advisable to discuss in advance with the DOH if home lab collection is planned to be provided within a clinical trial.

7.12 Considerations/Requirements for Direct-to-Patient Study Product Delivery

From the research conducted, no regulations are in place with regard to DTP in a clinical trial context. However, existing guidance indicates that this is permissible within the standard medical care, see below:

The DOH’s “Standard on Delivery of Pharmacy Medication” (Feb 2020) sets forth the scope, requirements, and duties that must be fulfilled by a DOH-licensed pharmacy to assure the security and safety of delivery systems. 

It is advisable to discuss in advance with the DOH if a direct-to-patient study product is planned within a clinical trial.

7.13 Considerations/Requirements for the Use of Telemedicine

From the research conducted, no regulations are in place with regard to use the of Telemedicine in a clinical trial context. However, the Department of Health has issued the following documents which support the provision of Telemedicine within the standard of medical care settings:

• Annex to the Cabinet Resolution No. (40) of 2019 concerning The Implementing Regulations of Federal Decree-Law No. (4) of 2016 on Medical Liability - Controls and Conditions for the Provision of Telehealth (Telemedicine) Services (See page 44 of the Book 6: Medical Liability Legislation)
• DOH Standard on Tele-Medicine (Sept 2020)

The Annex to the Cabinet Resolution No. 40 of 2019 sets forth the Conditions and Controls which apply to all areas of provision of Telehealth Services. 

The DOH Standard on Telemedicine sets forth the minimum requirements for the provision of telemedicine services by DOH-licensed providers to ensure safe and quality services.

Please note that, while clinical trials are not within the scope of the above-mentioned Telehealth Cabinet Resolution and DOH Standard, the fact that Telemedicine is well established in Abu Dhabi within the standard of medical care may serve as a precedent for Telemedicine to be used within a clinical trial. 

It is advisable to discuss in advance with the site/s, local EC/s, and DOH if telemedicine is planned to be used in a study.

7.14 Considerations/Requirements for the Use of Wearables

The use of wearables is not addressed in the existing policy or guidance on clinical research. However, the Abu Dhabi DOH and ethics committee may accept the use of wearables within clinical trials. 

In June 2023, the Department of Health published the “Guidelines on Real-world Data/real-world Evidence-based Clinical Research”. This guideline contains provisions on digital health technologies, described as those used to gather health-related data remotely. 

Section 3.1.4 - Digital Health Technologies - indicates the following:

“Digital health technologies are used to gather health-related data. These include applications, sensors, wearables, and other technologies, such as ingestible devices and implants, which might be used to collect RWD as part of routine clinical care for patient-reported outcomes or home-based measurements. Other sources of RWD might utilize devices that capture indicators of function. These might be used as supportive evidence of the safety or efficacy of a treatment. Both the device and any tool (such as a questionnaire) used in data capturing have to be suitability validated for the measurements required. The relevance, objectivity, and practicality of measurements should be considered, considering the user's disease, age, and potential functional abilities. The devices may be regulated as medical devices, and applicable laws and regulations on the territory of Abu Dhabi are to be applied."

7.15 Considerations/Requirements for Remote Monitoring

Remote monitoring of clinical trials is not addressed within the existing regulatory framework.

It is advisable to discuss in advance with the DOH if remote monitoring is planned within a clinical trial.

7.16 Considerations/Requirements for Digital Health Technologies (such as Platforms)

In September 2020, the DOH published the “DOH Policy on Digital Health”. One of the key objectives of this policy is to redefine health and medical technology to include platforms and digital applications and technologies as appropriate. The DOH intends to ensure that “appropriate and applicable platforms and digital applications and technologies fall under the same oversight, testing, and regulation as “traditional” or non-digital health and medical technologies and tools.” 

Until further guidance is released, it is advisable to discuss in advance with the DOH when Digital health technologies are planned to be used within a clinical trial.