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.)?

Dubai Health Authority has not yet issued specific guidance on conducting clinical trials involving decentralized elements, and while not prohibited, decisions are taken on a case-by-case basis.

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

Dubai Health Authority has not yet issued specific guidance on conducting clinical trials with decentralized elements.

There are decentralized elements such as telehealth, 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 Dubai with decentralized elements to engage with the planned participating sites, with the Ministry of Health & Prevention (MOHAP) and with the Dubai Scientific Research Ethics Committee (DSREC) 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.

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

Dubai Health Authority has not yet issued specific guidance on conducting clinical trials involving decentralized elements, and while not prohibited, decisions are taken on a case-by-case basis.

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?

From the research conducted, this was not directly evident.

However, there are mergers and acquisitions, and strategic engagement between healthcare stakeholders and public and private entities, which are occurring in the UAE, with a focus on developing the healthcare sector, specifically the Dubai Industrial Strategy 2030. Dubai has established healthcare “free zones” as a means of attracting foreign investment into the UAE, to support its goal of becoming a global player in the healthcare and research sector.

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 Dubai 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

While the Dubai Health Authority has issued ”Guidelines for Patient Consent”, the scope of this guideline is not specific to clinical research but standard medical care and procedures. 

After consultation with the DSREC, it has been confirmed that while eConsent is not prohibited in Dubai, there is currently (as of May 2024) no specific guidance on this matter, and the acceptability of eConsent is on a case-by-case basis. Therefore, it is recommended that Sponsors planning to use eConsent and eSignatures in a clinical trial in Dubai to discuss with the authorities prior to submission.

If we take into consideration the points raised on electronic consent within the “Guidelines for Patient Consent”, those are as follows:

• If the health facility is using electronic health records, an electronic signature is acceptable.
• The content of the electronic Informed Consent forms shall meet the same requirements as that of the manual consent mentioned within the guidance.
• For storing and retrieving the Informed Consent form, the electronic health system shall maintain records of each entry with identified authentication.

7.8 Considerations/Requirements for the Use of eSignatures

While the Dubai Health Authority has issued ”Guidelines for Patient Consent”, the scope of this guideline is not specific to clinical research but standard medical care and procedures. 

After consultation with the DSREC, it has been confirmed that while eConsent is not prohibited in Dubai, there is currently (as of May 2024) no specific guidance on this matter, and the acceptability of eConsent is on a case-by-case basis. Therefore, it is recommended that the Sponsor planning to use eConsent and eSignatures in a clinical trial in Dubai to discuss with the authorities prior to submission.

Within the above-mentioned “Guidelines for Patient Consent”, an electronic signature is defined as follows:

“Electronic Signature refers to any letters, numbers, symbols, voice or processing system in electronic form applied to, incorporated in, or logically associated with a data message with the intention of authenticating or approving the same.”

This definition originates from the UAE Federal Law No. (1) of 2006 Concerning Electronic Transactions & Commerce. Art. 8 indicates the following:

“Article (8)

(1) Where the law requires a signature on a document, or provides for certain consequences if a document is not signed, the electronic signature relied on within the context of Article (18) hereof shall satisfy the requirement. 

(2) Any person may use any form of electronic certification, unless otherwise stipulated by the law.”

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

ePROs are not addressed in the national legislation; however, the Dubai CA and ECs may accept the use of ePROs within clinical trials.

It is advisable to discuss in advance with MOHAP and the DSREC if ePROs are planned to be used in a study.

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

In 2012, the Dubai Health Authority’s Health Regulation Department issued the “Home Healthcare Regulation”  which permits home healthcare services to be provided by licensed health facilities upon approval from the Health Regulation Department. 

The clinical services which may be provided by a licensed physician are listed in clause 14.1 of the Regulation and include physician consultations in the patient’s home and telephonic follow-up consultations. 

Clause 14.2 lists the nursing care services that may be provided by a licensed nurse as part of home healthcare. 

Please note that while clinical trials are not within the scope of the Health Care Regulation, it may set a precedent for home healthcare to be used within a clinical trial setting.

A DHA license is a permit issued by the Dubai Health Authority (DHA) that allows healthcare professionals to work in the healthcare sector within Dubai. All healthcare professionals, including physicians, nurses, pharmacists, and other allied health professionals, must possess this license in order to practice in the Emirate. The DHA license certifies that the medical staff meets the necessary qualifications, standards, and competency levels to offer safe and excellent medical services. The DHA licensing process involves an assessment of the applicant’s qualifications and experience. The applicant also needs to pass certain examinations to demonstrate their skills and knowledge in their respective fields.

7.11 Considerations/Requirements for HHC - Home Lab Collection

See Section 7.10 above.

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.

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 Pharmacy Guideline” published by the Dubai Health Authority provides a section on the delivery of medication.

“Clause 15.2 Medications Delivery

15.2.1. 

DHA-licensed health facilities providing pharmaceutical services are responsible to ensure all relevant UAE federal and local laws, regulations, and standards are met for delivery of medicines and medical products.

15.2.2.

DHA-licensed pharmacies pursuing to provide Medications Delivery services are required to seek DHA approval for dispensing medications via a delivery system (Telepharmacy) through the (health facility/third party).

a. For application of delivering POM, OTC, and general medical products via a delivery system the facility should seek the approval of Telepharmacy services and must meet the licensure requirements such as but not limited to electronic platforms, online websites, and mobile applications. 

b. For application of delivering OTC medications and general medical products via a delivery system the facility should seek the approval of add-on services to the facility (Home delivery service).

15.2.3

The DHA-licensed Pharmacy may engage in third-party agreement for the delivery of Medications.

15.2.4

The pharmacy has to mention the third party’s name in their application form along with photos of the third party’s vehicle.

15.2.5

A copy of the contract and an undertaking letter signed by the pharmacist in charge should be provided.

15.2.6

The pharmacy may provide a guideline detailing and outlining the criteria for safe dispensing and patient counseling if using delivery systems.”

15.2.7

Delivery of medication and medical products to patients shall be undertaken through secure and traceable means.

15.2.8

The DHA-licensed Pharmacy and pharmacists in charge must take full responsibility for any medication errors or adverse events resulting in inappropriate or unsafe delivery of medications through the facility delivery service or/third-party delivery company services." 

It is advisable to discuss in advance with MOHAP and the DSREC if DTP is planned to be used in a study.

7.13 Considerations/Requirements for the Use of Telemedicine

From the research conducted, no regulations are in place with regard to the use of Telemedicine in a clinical trial context. However, Dubai’s Health Authority has a very comprehensive policy and standards on Telehealth applicable to the standard medical care policy indicating that this is permissible within the standard medical care.

Within the standard medical care, Telehealth is permitted and by definition includes “the use of telecommunications and virtual technology to deliver healthcare services remotely” to “exchange patient’s medical information from one site to another via the available electronic communications platforms such as “two-way video, email, smartphones, wireless tools and other forms of telecommunication technology to assess and evaluate the patient’s health status for treatment purposes”. 

Telehealth includes “patient assessment, diagnosis, treatment, therapy, referral, provider and patient education and self-care, exchange of health information services via telecommunications and digital communications technologies”, and is divided into six areas:

1. Teleconsultation
2. Telediagnosis
3. Telemonitoring (remote patient monitoring)
4. mHealth (Mobile Health)
5. Telerobotics and robot-assisted services
6. Telepharmacy

Telehealth platforms intended for internal or commercial use shall be assessed and approved by the DHA.

Please note that while clinical trials are not within the scope of the Telehealth Services, it may serve as a precedent for Telemedicine to be used within a clinical trial setting. It is advisable to discuss in advance with MOHAP and the DSREC if telemedicine is planned to be used in a study.

7.14 Considerations/Requirements for the Use of Wearables

The Dubai Health Authority's Standards for Telehealth Services allow for Telemonitoring/Patient Remote Monitoring (Clause 13. Standard Nine) through approved telehealth platforms and medical devices, and Mobile Health (Clause 14. Standard Ten). These services enable the remote monitoring of patients via monitoring devices that collect and transmit patient data.

Any telehealth platform and medical devices must be approved by the MOHAP.

7.15 Considerations/Requirements for Remote Monitoring

From the research conducted, no regulations or guidance are in place with regard to remote monitoring within the clinical trial context.

It is advisable to discuss in advance with the sites, MOHAP, and the DSREC if remote monitoring is planned to be used in a study to assess acceptability as well as any security/data protection safeguards required.

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

As indicated in Section 7.13 above, telemedicine is well used and practiced within the standard clinical care in Dubai.

Section 5.3 of the Telehealth standard sets forth the requirements for a Telehealth platform.

“5.3. Telehealth Platforms:

5.3.1. All existing telehealth platforms intended for internal or commercial use shall:

a. Be assessed and approved by DHA through health facility licensing prior to in-house implementation or go-to-market implementation. 

b. Have legal representation in Dubai with relevant commercial/trade license issued by the concerned authority.

c. Have an assigned Business Technical Director.

d. Provide access to technical support with defined escalation matrix (response and resolution) for platform users (physicians and patients).

e. Comply with the requirements and ensure all communication channels are approved by the TRA in the UAE.

f. Ensure all data stored complies with Federal Law No. (2) for the year 2019 on the Use of Information and Communications Technology (ICT) in Healthcare.

(i) All data centers shall be at least Tier 3 Certified. Standards for Telehealth Services Code: DHA/HRS/HPSD/ST-14 Issue Nu: 3 Issue Date: 22/08/2021 Effective Date: 22/08/2021 Revision Date: 22/08/2026 Page 23 of 91.

(ii) All data shall be stored in a server located at a Cloud Service Provider (CSP) certified by Dubai Electronic Security Centre (DESC) in the UAE. 

(iii) All platforms shall have HIPAA compliance certification. 

(iv) All platforms shall have ISO 27001 compliance certification. 

g. It is not permitted to store, develop, or transfer data and health information outside the country that is related to health services provided within the country, except in cases mentioned in Article no. (2) of the Ministerial Decision no. (51) of 2021.”