Decentralized Clinical Trials (DCTs) FAQs
January 2024
General Considerations
Q1. What is a DCT?
A1. DCTs are defined as studies “executed through telemedicine and mobile/local healthcare providers, using processes and technologies differing from the traditional clinical trial model”.1 Also, in a decentralized clinical trial (DCT), some or all of a clinical trial’s activities occur at locations other than a traditional clinical trial site. These alternate locations can include the participant’s home, a local health care facility, or a nearby laboratory.
Q2. Should there be a central location/physical location in a DCT?
A2. It is recommended that there be a physical location for inspection purposes where inspectors or monitors can centrally review trial related records whether they are stored in a secure electronic location or at a physical site. For study records stored electronically, processes should be in place to allow monitors or inspectors to review the records remotely.
Q3. What are some participant factors and potential challenges 2 that should be considered when designing a DCT?
A3. When designing a DCT, an investigator should think about the following domains 3 from the participant perspective:
- Communication: The DCT should include procedures to assure that robust communication is maintained among participants, third-party vendors, and the investigator.
- Orientation/Training: The investigator should have provisions in place to orient and/or train participants about their responsibilities in the study, including completing study procedures, uploading study data, using technology for the study, etc.
- Digital and Mobile Technology: The investigator should be aware of technologies being used in the study (e.g., “wearable” ECG cardiac monitors) and consider participant abilities to understand how to use them. The investigator may also need to consider if devices used by participants will be provided by the study, or of the participant uses a personal device (e.g., their own cell phone, or tablet) for study procedures. Further, if any of the study devices require an internet or cellular connection, the investigator may need to consider access concerns that may be insufficient in some areas where participants live. The investigator should also plan for how enhanced connective services man be needed for some participants.
- Personal Privacy/Data Confidentiality: Participants should understand that the investigator will implement all available protections to protect participant identity and their personal privacy, and the confidentiality of their data. The investigator will need to inform participants that study or identifiable data that may be transmitted via various communication platforms and technologies, which may not guarantee confidentiality.
- Safety: The DCT should be designed and conducted in a manner that maximizes safety and well-being for participants. Specifically, participants should be aware of adverse event (e.g., acute side-effects) response procedures, such as contacting 911. The investigator should consider how participants can communicate their research status to EMTs, the Emergency Department, or their primary care provider. If a third-party contractor (e.g., a home health aide) is utilized, training for the reporting and response to participant safety events is essential.
- Costs: The participant in a DCT should be informed if any costs could be incurred during their time in the study. For example, if participant’s cellular data plan is limited, the participant should be notified of this possibility and any financial responsibility.
- Culture/Socio-Economic factors: In a DCT, participants may be enrolled with diverse cultural backgrounds and represent different socio-economic strata. For example, if persons may be enrolled that speak a language other than English, to improve diversity, the investigator should consider in the DCT design means to include these persons by utilizing technological resources or contracted third-party entities who speak the language of those participants. For persons for which study participation might pose a financial burden, the investigator may consider means to provide financial assistance (e.g., furnishing a participant with a tablet to complete study diaries).
- Special Populations and Specific Needs: If children or other vulnerable populations are to be enrolled in a DCT, special considerations may need to be designed into the research to engage parents or Legally Authorized Representatives (LARs). If persons with certain disabilities are to be recruited, the DCT should be designed to accommodate them, if appropriate (e.g., smart phones for the visually impaired, or TTY/TRS phones for people with hearing impairment).
Note: Many of the answers to the FAQs are directly from the following FDA guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices Draft Guidance for Industry, Investigators, and Other Stakeholders (fda.gov)
1 Clinical Trial Transformation Initiative, CTTI Recommendations: Decentralized Clinical Trials 2 (2018), available at https://www.ctti-clinicaltrials.org/sites/www.ctti-clinicaltrials.org/files/dct_recommendations_final.pdf.
Considerations for Remote Clinical Trial and Clinical Trial-Related Activates
Q4. What should be considered for remote clinical trial and clinical trial-related activities in a DCT?
A4. Please see the following for recommendations: Decentralized Clinical Trials for Drugs, Biological Products, and Devices Draft Guidance for Industry, Investigators, and Other Stakeholders (fda.gov)
Special consideration should be given to account for logistics in the conduct of the trial e.g., participant safety; privacy, confidentiality, and security; risks to non-subjects; vulnerable populations; adequate oversight; compliance with relevant laws, regulations, and local requirements (for example, investigational product shipment, prescribing, telemedicine, etc.).
Digital Health Technologies
Q5. What are Digital Health Technologies (DHT)?
A5. A DHT is a system that uses computing platforms, connectivity, software, and/or sensors for health care and related uses. These technologies span a wide range of uses, from applications in general wellness to applications as a medical device. They include technologies intended for use as a medical product, in a medical product, or as an adjunct to other medical products (devices, drugs, and biologics). They may also be used to develop or study medical products. Please see: Guidance for Industry (fda.gov)
Q6. What should be considered when using DHT?
A6. DHTs used in a DCT should be available and suitable for use by all trial participants. When a trial permits participants to use their own DHTs, provided DHTs should be available as an option to ensure that participants who do not have a protocol-specified DHT are not excluded from the DCT for that reason (e.g., lower socioeconomic groups who cannot afford the DHT, such as access to a Smart Phone).
The trial protocol should include consideration of issues such as privacy, confidentiality, security, data breaches, third-party use of personal data, terms of service, and potential harm (both physical and non-physical).
There should also be consideration given to account for and minimize risks regarding the data management plan, and software programs included in the protocol.
Role of Sponsors and Investigators
Q7. What is the role of the Sponsor in a DCT?
A7. Sponsor responsibilities are the same for DCTs and traditional site-based clinical trials. Please see the following guidance for a list of the Sponsor’s role in a DCT: Decentralized Clinical Trials for Drugs, Biological Products, and Devices Draft Guidance for Industry, Investigators, and Other Stakeholders (fda.gov)
Q8. What is the role of the Investigator in a DCT?
A8. Investigators are responsible for the conduct of the DCT and the oversight of individuals, who should be qualified and experienced, that are delegated to perform trial-related activities, including ensuring that these delegated activities and/or tasks are conducted according to the investigational plan, applicable regulations, and relevant laws. Please see the following guidance for a list of Investigator responsibilities in a DCT: Decentralized Clinical Trials for Drugs, Biological Products, and Devices Draft Guidance for Industry, Investigators, and Other Stakeholders (fda.gov)
The investigator is also responsible for delegation, oversight, research protocol training, and safety reporting expected from local Heath Care Providers (HCPs). There should be consideration for how non-trial personnel like HCPs address potential risks e.g., abnormal health findings, safety, privacy, confidentiality, security, child abuse, sanitary conditions, neglect, and mandatory safety reporting. In addition, the investigator should assure that HCP personnel are trained in responding to health events such as acute side-effects, e.g., initiating CPR, delivering rescue medications, or calling 911.
Third Party Collaborators
Q9. Do third party collaborators who participate in a DCT require IRB oversight?
A9. Any third party collaborators that are engaged in research require IRB oversight. Common examples of engagement are a survey firm/third party platform delivering a survey to participants for research purposes and/or a home health care agency conducting research. Please review this JHM IRB guidance for additional information: Sponsor Contracted Third-Party Collaborators
Remote Consent
Q10. Can remote consent be used in a DCT.
A10. Yes, investigators may obtain electronic informed consent from trial participants at remote locations provided that all applicable regulatory requirements regarding informed consent are met. The JHM IRB must approve use of an electronic consent model either as part of the initial application or via a Change in Research. Please see the following guidance: Electronic and Remote Consent
Monitoring
Q11. Is the sponsor required to ensure there is proper monitoring in a DCT?
A11. Yes, The sponsor is required per regulations to ensure proper monitoring of the investigations and to ensure that the investigations are conducted in accordance with the general investigational plan and in accordance with applicable FDA IND or IDE regulations. Sponsors should implement a safety monitoring plan to ensure the safety and welfare of trial participants in a DCT.
Software
Q12. Should the sponsor consider what software to use in a DCT?
A12. Yes. The sponsor should consider what software to use in a DCT. The software used will need to meet considerations for data reliability, security, and privacy. Please see the following for recommendations: Decentralized Clinical Trials for Drugs, Biological Products, and Devices Draft Guidance for Industry, Investigators, and Other Stakeholders (fda.gov)
Submitting a DCT to the JHM IRB for Review
Q13. Where should I indicate in the eIRB application that my study has a DCT component?
A13. You should indicate “Yes” in section 10 (Study Location) item 3 of the eIRB application.
Q14. Should my protocol describe the de-centralized components of the study?
A14. Yes, the protocol should clearly describe the de-centralized components of the research and address the considerations above for how the de-centralized aspects of the trial will be managed. The protocol should be uploaded to section 6 (Protocol Information) item 2 of the eIRB application.
Q15. What if the decentralized component of the study involves sharing Johns Hopkins Medicine person-level data with outside partners?
A15. If you will share Johns Hopkins Health System or School of Medicine person-level date with outside partners, you must fill out section 36 (Data Confidentiality) of the eIRB application as follows:
- Please indicate “Yes” in section 36 item 2 and answer the items that appear
- Please answer item 5 on the Risk Tier Worksheet
As a note, the consent form should disclose who may access participant information.
Q16. Who should I contact to discuss questions concerning DCTs?
A16. You can request a consult and a member of the Office of Human Subjects Research team will reach out to you.