Table 1 Description of innovative approaches considered

Mobile (home) nursing

Nursing services that visit the patient at home and can provide certain activities described in the trial protocol. Possible activities may include drug administration, blood draws, biological sample collection, drug accountability, physical exam and patient safety check.

Investigational medicinal product (IMP) home delivery

IMP home delivery refers to courier services that transport the IMPs from a site or a depot to the patient’s home or to a local facility (e.g. local pharmacy).

Home/local infusion services

Intravenous or subcutaneous administration of drugs or biologicals to an individual at home or local infusion centre.

 Mobile laboratory

Laboratory that is either fully housed within or transported by a vehicle.

 Local laboratory

Local laboratories are located at the local investigator site or close to the patient. They may not be a lab that the sponsor has an agreement with and could be selected by the investigator based on their preference/experience or patient location. The lab could be used to perform diagnostics/tests that are required per protocol.

 Local imaging centre

Located close to the patient and used to collect imaging that is required per protocol.

 Telemedicine/telehealth

Practice of medicine using technology to deliver care at a distance. A physician in one location uses a telecommunication infrastructure (e.g. video or phone calls) to deliver care to a patient at a distant site. Telehealth is the broader term to refer to technologies that provide care and services at-a-distance.

 Remote assessment of patients by the observer (i.e. traditional clinical outcome assessment [COA] conducted remotely)

Remote assessment of patients by the observer (i.e. COA conducted remotely): performance outcome assessments (PerfOs), patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs) can be evaluated via telemedicine/telehealth. The assessment method itself cannot be modified to be employed remotely, e.g. 6-min walk test can be administered by a clinician using a video interface.

 Remote data collection using digital tools for different purposes

Digital health technologies (DHT) such as sensors and wearables can be used to capture patient data remotely within a clinical study. The data captured may be a measure of physiology, function and/or behaviour, e.g. blood pressure (physiology), e-diary (behaviour), step counter (function) and sleep tracker (function). The non-invasive monitoring devices can be connected to a wireless network through Bluetooth, Wi-Fi or cellular connection to transmit a patient’s measurements directly to their health care provider or other monitoring entity.

 Remote collection of physiologic data for remote patient monitoring through DHT

Remote monitoring devices (e.g. wearables, hand-helds, stationary in-home monitoring and digital interfaces) can be used to measure the physiology of patients. The devices can also apply algorithms to transform a patient’s physiological parameters into a novel index or alarm that may aid a health care professional in the diagnosis of a particular condition or disease state/severity. Most use cases will fall under the medical device definition (defined in local regulations) and be classified as Software as a Medical Device (SaMD)/Medical Device Software (MDSW).

 Remote collection of outcomes data through DHT

DHTs can be used to collect digital measures that can construct a COA or a biomarker and be used as endpoints in trials.