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.)?

Yes. In principle, there is nothing to prevent the implementation of a DCT model in New Zealand. The specific elements of decentralization to be included in a trial are subject to ethics approval depending on the nature of the study and the level of risk. However, there are no known formal obstacles to them being conducted.

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

No. There is no specific guidance on the conduct of decentralized trials. Part 11 of the NZ regulatory guidelines on clinical trials does not make reference to decentralized trials.

7.3 What is the overall acceptability of DCT elements by the regulatory authorities and Ethics Committees?

In general, Medsafe and NZ ethics committees are open to the adoption of DCT elements within clinical trials. The use of DCT elements increased during the COVID-19 pandemic and they continue to be used in studies to enhance patient experience and to access patients in remote areas.

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. 

There is no evidence to suggest that a fully decentralized trial has yet been conducted in New Zealand. Several trials have been conducted with DCT elements.

Elements of trial conduct have been allowed over the last few years because of the COVID-19 pandemic. This has impacted both COVID and non-COVID studies. As a result, there is an increasing acceptance of decentralized trial conduct through the use of a hybrid model.

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

No.

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

The New Zealand Association for Clinical Research has introduced SOPs regarding the handling and shipping of biological samples from DCTs and documentation management for DCTs. At this time, there are no other guidelines specific to DCTs.

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

The use of eConsent/Remote Consent is acceptable according to the NZ guidance, subject to ethics approval.

Informed consent must be in writing if a patient is to participate in any research involving a healthcare procedure where informed consent is required. Researchers should document participants’ consent. 

Where participants give consent in a form that is not written, researchers must record it in some other manner (e.g. through audio, video, or electronic evidence, or a written note in the file). 

In some cases, consent can be demonstrated by a participant’s actions; for example, returning a completed questionnaire may be considered implied consent.

7.8 Considerations/Requirements for the Use of eSignatures

There is no specific guidance on the use of eSignatures in clinical trials. 

Electronic signatures can be used whether the signature must be witnessed or not. A best practice is for the witness to be physically present, even when an electronic signature is required. However, there have been some practices put in place in order to permit virtual witnessing, especially during the pandemic. These require additional safeguards and evidence to show that the witness actually saw the signature being applied, even though they were not physically present.

The Electronic Transaction Act of 2002 grants a presumption of reliability to eSignatures and provides guidelines for when the burden for being “as reliable as appropriate” is met.

The following are the conditions for eSignature reliability in New Zealand:

• The eSignature was generated under the signer’s full and total control and under no duress or persuasion from another party.
• The eSignature, as generated, was linked only to the signer and not to any other party.
• The eSignature is used to support and guarantee the validity or approval of the information or document to which it is applied or affixed.
• There are means by which to detect any alterations made to the eSignature after it has been created initially to protect the integrity of the information.

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

There are no specific guidelines on what is acceptable – this forms part of the review and assessment by the RA and ethics committee.

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

There are no specific guidelines on what is acceptable – this forms part of the review and assessment by the RA and ethics committee. It depends on the product type, method of administration, and nature of the intervention. 

7.11 Considerations/Requirements for HHC- Home Lab Collection

There are no specific guidelines on what is acceptable – this forms part of the review and assessment by the RA and ethics committee.

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

There are no specific guidelines on what is acceptable – this forms part of the review and assessment by the RA and ethics committee.

7.13 Considerations/Requirements for the Use of Telemedicine

Teletrials are generally acceptable in New Zealand. The sponsor must decide up front the approach to monitoring and include this in the protocol. Remote monitoring has become more accepted as a consequence of the COVID-19 pandemic and to help provide access to patients in remote locations. 

7.14 Considerations/Requirements for the Use of Wearables

There are no specific guidelines on what is acceptable – this forms part of the review and assessment by the RA and ethics committee.

7.15 Considerations/Requirements for Remote Monitoring

There are no specific guidelines on what is acceptable – this forms part of the review and assessment by the RA and ethics committee.

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

There are no specific guidelines on what is acceptable – this forms part of the review and assessment by the RA and ethics committee.