As a result of the COVID-19 pandemic travel restrictions of varying degrees have been imposed in most countries, consequently patients are not able to obtain their clinical supplies directly from the sites. In response to this situation, PRA has established a method of delivery of clinical trial supplies direct to the patient.
Before implementing Direct To Patient (DTP) consider the following
- Sponsor discussion and approval
- Is DTP allowed per country regulations? If not, are deviations allowed in response to COVID-19?
- Are there safety concerns with providing IP at home?
- Does patient agree to receive IP at home?
- Is CEC/LEC/IRB/RA approval required?
- Determine who will contract courier (PRA, Site, Other), consider timelines and maintaining patient privacy
- Ensure all protocol deviations are documented
- Ensure no patient personal information is provided to PRA or Sponsor
Regulatory Strategies to consider
Always consult and stay in close communication with assigned study regulatory functional lead (GRAL) for appropriate guidance on mitigations
There are various regulatory pathways that may be taken to deal with deviations from our normal study procedures and processes which would include DTP. These will vary from country to country and study to study. Discussion with the sponsor and project team will be required to establish the regulatory implications, consequences, country legislation and then determine the best possible solution, for example:
- Urgent Safety Measure
- Protocol deviation
- Breach of GCP
- Temporary halt of the trial
- Early End of Trial
Overview of process to follow
The following guidance has been issued to enable provision of study medication to patients in response to COVID-19 where patients are unable to have the on-site visit as defined in the protocol. The process may have to be modified according to the specific study requirements. Direct to Patient supply is not included in the protocol but in order to allow patient to continue receiving treatment with investigational product (IP), special delivery of drug may be used as documented in this process.
- Obtain CEC/LEC/IRB approval and Regulatory Agency approval, as required, on the DTP process to be followed for your study. Ensure justification is provided to the approving authorities.
- The site should document approval by the Sponsor and Investigator to provide IP to the patient using the Direct To Patient Investigational Product Transfer Form, Part 1 and file this in the site file.
- Obtain patient consent to provide personal information (name, contact details) to courier. Document method and date consent was obtained in the Direct To Patient Investigational Product Transfer Form
- Complete all study documents and maintain on site study files per protocol requirements.
- Complete a protocol deviation to document all changes from protocol defined processes.
- Schedule the on-site visit as soon as possible once the risk of COVID-19 is reduced. Review IP compliance.
Patient Consent is required to provide patient name and contact details to the courier company
In order for the courier to deliver IP to the patient certain patient details will need to be provided such as the name, address and contact details of the patient. The patient’s consent to supply the courier with these details needs to be obtained. This consent can be sought using the following depending upon the urgency of the supply and availability of the patient:
- Patient to sign addendum to the ICF. A template has been provided and this may be adapted as per local and study requirements
- Consent language sent to the patient via email as described in the Direct to Patient (DTP) Process for Sites: DTP Investigational Product (IP) Process
- The site may obtain consent via phone and document this is the patient’s medical record.
- Patient to sign the consent within the DTP Transfer Approval Form upon receipt of the IP from the courier, i.e. they will be signing retrospectively.
Option 1 is the preferable method to obtain the patients consent as this will follow all study and GCP requirements, however, it may not be possible hence the inclusion of alternative methods. The alternative method used must be determined at a study/country/site/patient level and justified in the notification/application submitted to the RA/CEC/LEC/IRB.
Be sure to include the consent method when notifications are sent to the authorities via the applicable regulatory procedure and include a justification.