Medial Research Network

General FAQs

1. How rapidly can MRN initiate an HTS project?

MRN recognizes the urgency that the COVID-19 pandemic and travel restrictions have placed on ongoing clinical trials and have received multiple requests for assistance. As a result, we have developed a streamlined approach to evaluating and operationalizing these requests for support.

This is a non-standard process that has been developed specifically to address these urgent needs in response to the current crisis.

In order to evaluate the viability of Home Trial Support (HTS) for our clients ongoing studies, we will need the following documents:

• Request noting that this is COVID-19 Related
• Final Protocol
• Investigator Brochure
• Lab manual
• Pharmacy Manual
• Master ICF
• Study timelines
• Status overview of countries/sites/subjects
• Specific visits and activities to be conducted for the HTS visit

Following a request for support (including the documents listed above), our process begins with a ‘rapid response’ meeting between our SMEs and the CRO/Sponsor to discuss the specific study needs and to ascertain feasibility for HTS services. This rapid response meeting will likely be held 24-72 hrs. after the request is submitted.

Following the meeting, and assuming it is feasible to provide the support requested, MRN will develop a working framework and issue a ballpark budget and Letter of Intent (LOI). We expect that process will be completed in 48-72 hours following the meeting.

The streamlined approach we have designed is intended to be able to deliver visits within 5-7 weeks (c.f the standard 12-15 week set-up). The achievement of the accelerated timeline is contingent on the sponsor and/or CRO making an immediate commitment based on the ballpark budget and LOI.

Due to the dynamic and iterative nature of responding in an urgent manner, we will unable to provide a full and final budget at the time of the LOI. Our recommendation is to be as pro-active as possible during set-up so that the trial can be set up everywhere that you may need support and prevent the inefficient, and costly, chasing of the impact of the current crisis on your trial.

With respect to regulatory issues, it appears that IRB/EC are sympathetic to the need for home visits in order to protect the safety of subjects. To date, we have received no negative feedback from regulatory authorities and ethics committees. However, it will be up to each study team to determine the regulatory acceptability of HTS visits for their study.

The accelerated timelines will require the availability of your clinical team to provide timely document review and approval, as needed, during the set-up process

Prior to the first HTS visit, we will need a full contract in place

2. Can Home Health Care be used where previously they were not considered?

FDA: Since trial participants may not be able to come to the investigational site for protocol-specified visits, sponsors should evaluate whether alternative methods for safety assessments (e.g., phone contact, virtual visit, alternative location for assessment, including local labs or imaging centres) could be implemented when necessary and feasible, and would be sufficient to assure the safety of trial participants. Sponsors should determine if in-person visits are necessary to fully assure the safety of trial participants (for example to carry out procedures necessary to assess the safety or the safe use of the investigational product appropriately); in making the decision to continue use or administration of the investigational product, the sponsor should consider whether the safety of trial participants can be assured with the implementation of the altered monitoring approach.

If scheduled visits at clinical sites will be significantly impacted, certain investigational products, such as those that are typically distributed for self-administration, may be amenable to alternative secure delivery methods.  For other investigational products that are normally administered in a health care setting, consulting FDA review divisions on plans for alternative administration (e.g., home nursing or alternative sites by trained but non-study personnel) is recommended.  In all cases, existing regulatory requirements for maintaining investigational product accountability remain and should be addressed and documented.

EMA: Where a trial participant is unable to attend the site, other measures, such as home nursing, if possible given social distancing needs, or contact via phone or telemedicine means, may be required to identify adverse events and ensure continuous medical care and oversight. However, the limitations and risks of such methods and the requirements for data protection should be considered and such alternative arrangements need to be adequately documented.

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf

UK: If patient visits need to be moved, the options are to set up as a sub-contracted site of the existing site if oversight can be maintained by the existing site, or to set up new sites, or to implement direct home care arrangements by the sponsor. For study types where the addition of new sites is a substantial amendment, existing guidance for submitting a substantial amendment for new sites should be followed. In all other cases, existing guidance for non-substantial amendments and addition of new sites should be followed.

https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/covid-19-guidance-sponsors-sites-and-researchers/

 

Other FAQs:

- Country Coverage FAQs

- Expedited Start-Up FAQs

- Home Trial Support FAQs

- Supplies FAQs

COVID 19 FAQs
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