Alternative to Clinical Site Visits During COVID-19 & Beyond

A patient with a rare immune deficiency was able to continue clinical trial participation during the coronavirus pandemic.

The Challenge

Our client contacted us because a patient participating in a clinical trial was requesting a home visit in place of a 24-hour extended site visit, as he was not comfortable travelling to the clinical site (a hospital) due to the COVID-19 pandemic.

The patient requested that the visit be conducted via an extended stay at a local hotel as he did not want the study staff in his home due to concern around the transmission of the virus.

This high level of concern about the virus was due to the patient having a rare disease impacting the primary immune system.

Therefore, we had to ensure the patient was well-protected during their ongoing trial participation and that we took every precaution when it came to their physical and mental well-being – avoiding stress and overwhelming as well as mitigating infection risk.

Critically, the patient in question was the first and only patient enrolled in the clinical trial at this time due to the rare nature of their condition. It was critical for these samples to be collected in order for the study to progress.

We also had a number of logistical challenges to address, including arrangements for specialist equipment and multiple clinical staff members to complete procedures including:

• Blood draws
• ECG
• Physical and speciality exams
• Patient-completed surveys
• Video ‘televisit’ with the Principal Investigator

The Solution

We arranged for the clinical visit to take place in a hotel suite, with equipment and supplies being delivered to the study nurse directly as well as to the hotel.

We had to ensure our courier service provided dry ice so samples could remain frozen before shipping, and support the nurse to set up a pseudo-clinical space in the living room area of the hotel suite. We managed all arrangements with the hotel, whose staff were extremely accommodating and helpful.

A study nurse was able to complete the majority of the procedures, and we booked her a room in the same hotel, enabling her to rest between blood draws and be readily available to complete the visit. In preparation for this, she attended several training meetings and was talked through all procedures by a Clinical Research Associate (CRA) from the client’s team.

A physician’s assistant was also hired to assist with the physical and other exams.

The Outcome

As a result of arranging this hotel stay in place of a clinical site visit, we successfully addressed the patient’s apprehension and allowed them to continue their study participation with peace of mind.

The visit was successful, and the client was able to collect samples which were vital to the study’s continuation.

Both the patient and sponsor were highly satisfied with the level of service they received and the outcome of the visit, which ensured the ongoing success of the study.

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