International Clinical Trials Day – 20th May – A Brief History of Telemedicine, a concept with Scottish Heritage!

In just over two weeks’ time on May 20th, we will “celebrate” the anniversary of the first recognised clinical trial in history, namely the evaluation of citrus fruit for the treatment of scurvy by a Scottish physician called James Lind in 1747. Methodological advances in trial design and technology led to the first Multicenter trial being performed in 1943 and the first randomized double-blind trial in 1946. Regulatory frameworks that protect the patient (declaration of Helsinki and Good Clinical Practice) have been developed and are constantly modified to keep up with technology advances).

Advances in technology have played a critical role in clinical trial delivery. In 1843, Alexander Bain, a Scottish mechanic invented the fax machine. Thirty-three years later in March 1876, fellow Scotsman, Alexander Graham Bell uttered the immortal words “Mr Watson - come here - I want to see you” to his colleague, who was in an adjoining room, using the first version of the modern telephone. Whilst Bain’s invention could transmit still photographs, it would be another 49 years before a fourth Scotsman, John Logie Baird unveiled his prototype television in 1925 at the Selfridges Department Store in London.

The Birth of Telemedicine

Amazingly, one year prior to this, in April 1924 the American magazine Radio News depicted on its cover a picture of a “radio doctor” who was linked to his patient using sound and vision! The earliest references in the literature to telemedicine however, appeared in the 1950’s referring to the transmission of radiological images by telephone over a distance of 24 miles. Use of video transmission for medical purposes was first used in 1959 (across a university campus); by 1964 this distance had lengthened to 112 miles. Over the next 30 years, institutions rolled out versions of telemedicine to meet their needs, but the lack of technological advancement limited the usefulness of telemedicine in multicenter clinical trials; this would change with the development of satellite television and the internet.

The ATTRACT (Applications of Telemedicine Taking Rapid Advantage of Cable Television Network Evolution) study, performed in 1998, evaluated the advantages and disadvantages of televisits for 200 patients across 17 sites in Germany, Greece, Italy, Northern Ireland, Spain. This was not a single study in terms of therapeutic area, but an evaluation of one technology by 17 sites. Results confirmed acceptance of the technology by staff and patients but noted that this could not replace fully the traditional face-to-face assessments. Additional studies of patient and staff satisfaction using other technologies over the next decade confirmed these views. In 2011, a Phase IV trial REMOTE (Research on Electronic Monitoring of OAB Treatment Evaluation) was launched that aimed to recruit patients online and was designed for 100% evaluation at home via a mobile app and home-delivery of Investigational Product. A year later the trial was discontinued due to lack of recruitment of the required patient population despite the claimed success in generating interest in the recruitment website and a promise to restart the trial once tweaks had been made (it never was).

Decentralized / Hybrid Virtual Clinical Trials

With the advances of mobile technology and the affordability and data-processing capability, the last few years have seen a surge in the development of mobile apps for recording a variety of health assessments (including the patients’ informed consent) anywhere with access to the internet with data collected centrally; Decentralized (also known as Virtual) clinical trials have arrived. In recognition of the patients’ need for traditional contact and also the requirements for assessments that have to be performed at site, trials are being designed to allow a mixture of traditional and remote assessments whenever possible (Hybrid Virtual Trials). The Coronavirus pandemic (COVID-19) has made this new form of trial even more attractive for continuing clinical trials research.

Telemedicine may not suit 100% patients; those with elderly parents may recognize the challenges of acting as the remote IT helpdesk (when the television remote won’t work or when the FaceTime application icon has just simply disappeared!) For the majority, however, the use-case of telemedicine will continue to expand beyond trials into routine appointments with GPs, helping to alleviate the pressures of home and work by reducing the amount of face-to-face time required between Doctor and Patient.