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Remote decentralized clinical trials are emerging
in the EU and UK.
The European Union has issued relevant guidelines
for such clinical trials.
December 2022
Last month, the European Union supplemented existing guidance by issuing new guidelines on how to conduct such clinical trials
.
To this end, Sidley's lead lawyer, Zina Chatzidimitriadou, is a senior lead lawyer
Lauren Cuyvers and trainee lawyer Bronwyn Tonelli
Seven considerations are discussed to help remote decentralized clinical trial sponsors in the EU conduct such clinical trials
in compliance.
Decentralized clinical trials (DCTs) differ from traditional clinical trials in that they contain a "remote" element that enables activities such as consent, treatment management, data collection, and monitoring to be conducted remotely, for example, at a patient's home
.
But
DCT remains subject to all laws and rules applicable to clinical trials, including the EU Clinical Trials Regulation and the General Data Protection Regulation (GDPR)
in Europe.
December 14
The European Medicines Agency (EMA), the European Commission (EC) and the Head of Pharmaceutical Agency (HMA) have published new EU-level guidance
on the dispersed elements of clinical trials in the form of a joint recommendation document.
The Recommendations document and other recent EU and UK guidance clarify the EU and UK
Some key considerations for DCT sponsors
.
1.
Patient recruitment and informed consent: DCT
Enrollment/exclusion criteria should include provisions related to appropriateness in the participant's home, such as temperature control
.
Electronic methods can be used to record written informed consent, but different countries may take different positions
on the permissibility of electronic consent.
Any used
The eConsent system must ensure that participant confidentiality is maintained, and source consent documents must be made available for inspection
during and after the trial.
Patient recruitment and informed consent:
2.
Electronic signatures: Electronic signatures are increasingly being applied to DCTs
scene
.
Some countries require the identity
of participants to be verified via a video link when providing an electronic signature.
Depending on the risk classification of the clinical trial and the degree of intervention, different types of electronic signatures may be required, and all electronic consent forms/electronic signatures must be complied with
GDPR
。 In general, when using electronic consent, it is a good practice, and even necessary, to conduct a data protection impact assessment to assess the risk from a data privacy perspective
.
Electronic Signature:
3.
Delivery and administration of investigational medicinal products (IMP): IMP delivery at home
All risk assessments should state the need for observation periods and contingency plans, storage conditions, drug liability, and readiness, stability, and robustness of delivery IMP
And manage
it at home.
The recommendation document recommends limiting the transport steps of active pharmaceutical ingredients and selecting authorized suppliers for distribution
.
Scenarios should consider IMPs
Delivery to the participant's home
.
Appropriate training and alternatives should be provided for trial participants to use personal devices to obtain trial data
.
Delivery and administration of investigational medicinal products (IMP):
4.
Patient monitoring and telehealth: The details of any monitoring strategy should consider all the tools, locations, and individual risks
involved in the dispersion element.
Monitoring strategies should not overburden clinical centres and should ensure that any adverse events
are reported appropriately.
Any digital/telehealth tool used must comply with validation and evaluation rules and follow the study protocol
.
Patient Monitoring and Telehealth:
5.
Data flow, management, and data reliability: The data collected must follow the same GCP as any other data collection method
Standard
.
If there are any concerns about data quality, remonitoring
should be considered.
In addition, all personal data processing within the scope of the DCT must comply with the GDPR.
What sponsors need to consider with
The key consideration/impact associated with DCT (as opposed to traditional clinical trials) is data flow
.
The traffic is in the DCT
The lieutenant will be very different, with a significant increase in the amount of data collected directly from patients and a greater
number of participants in the data flow chain.
This may have an impact
on, for example, data processing/transfer protocols, network security and virtual (remote) exercise of data protection rights.
Data flow, management, and data reliability:
6.
Primary Responsibility: Throughout the DCT, sponsors and investigators remain responsible for completing the DCT
Tasks
set forth in the scenario.
The rationale and scope of
the task should be clearly stated in the programme and in the written agreement between the responsible party and the delegate.
Primary Responsibility:
7.
Post-trial equipment recycling: Care should be taken to ensure that equipment provided for the trial is not considered an incentive
for study participants.
Equipment recovery after test:
Previously: Sidley LLP, "Navigating Decentralized Clinical Trials In the EU and the UK"
Previously: Sidley LLP, "Navigating Decentralized Clinical Trials In the EU and the UK"By Zina Chatzidimitriadou, Lauren Cuyvers, Bronwyn Tonelli
By Zina Chatzidimitriadou, Lauren Cuyvers, Bronwyn Tonelli
