**Digital tools and remote visits - Opportunities to safely deliver early phase trials** [Watch the talk here][1] Dr Dónal Landers, Director of the digital Experimental Cancer Medicine Team (dECMT) within in the Cancer Research U.K. Manchester Institute spoke about the use of remote, technology-based interventions in order to safely deliver early phase clinical trials without the need for patient hospitalisation. He outlined to two examples; the In Home and NOTION trials. Key messages: - Who they are: Digital experimental cancer medicine team (dECMT): a clinical, digital research group formed of clinicians, biomedical scientists, data & AI scientists and clinical operations. - Mission: To provide next generation patient cancer care through comprehensive data-driven evidence. This will enable 3 things: 1. The transformation of decision making. 2. Evolve the role of patients – Patient as a co-researcher. 3. Use of technology to improve patient care and improve patient outcomes. • Clinical trial framework ![enter image description here][2] 1. Identify clinical unmet need. 2. Generate a hypothesis & design a technological approach. 3. Consider regulatory and ethical navigation. 4. Design the clinical trial, write up the protocol and submit for ethical approval. 5. Test the hypothesis. 6. Accept or reject the results (technology & clinical benefit assessment). • Ongoing projects 1 - IN-HOME study: In-home measurement of creatinine led by Prof. Sandip Mitra and Dr Leanne Phillips. ![enter image description here][3] - Clinical unmet need: The majority of patients with renal dysfunction are currently ineligible for cancer trials. - Aim of study: To develop adaptive, data-driven and risk stratified eligibility criteria around renal function so patients with controlled renal dysfunction can enter into clinical studies. - Primary objective: Assess the feasibility and acceptance of patients taking measurements at home. - Clinical benefit: Understanding the potential for earlier diagnosis of changes in renal function through intensive monitoring and potentially allowing inclusion of cancer patients with renal dysfunction in clinical trials. - The patient delivers a blood spot. A device reads the creatinine measurements and the patient enters the data into an application. Results are presented back to clinician and also used to develop an acute kidney injury algorithm. 2 - NOTION study (iN-home Of cyTokines In immunotherapy patieNts): - Clinical unmet need: Ability to predict immune-related toxicities in patients treated with immune checkpoint inhibitors & distinguish differences in immune-related and chemotherapy-related toxicities. - Aim: To develop an algorithm able to predict whether patients will develop immune-related toxicities. - Dry blood spot sample into a Neoteryx mitra device, put device into sealed envelope and send to lab where an ELISA panel is carried out giving a broad range of cytokines. Results presented to clinician & data used to develop an algorithm able to identify future toxicities. - Long term this trial hopes to act as a steppingstone to similar remote detection for more advanced medicinal products such as CAR-T therapy. Further points: • Enhancing the use of technology will provide a way of protecting patients from face-face visits. • The teams is trying to understand the full ethical implications of home monitoring, how patients could intervene with their own treatments. Need to be careful that patient understands. • These trials must be held to the same standards as traditional clinical trials in order to ensure data is generated in a clinically robust manner. • Have to be careful that the algorithms don’t have a bias in terms of any demographic e.g. gender. • Patients could be digitally disenfranchised because they can’t afford a smart phone/don’t have access to the internet. • Overall, it is clear that for these pathways to enter the clinic, all components must be; robust, scalable, reliable and ethical. If this can be achieved, there is a huge scope of potential benefit for patients and researchers waiting to be unearthed. [1]: https://osf.io/kuyv6/ [2]: https://mfr.de-1.osf.io/export?url=https://osf.io/q7vgp/?direct%26mode=render%26action=download%26public_file=False&initialWidth=758&childId=mfrIframe&parentTitle=OSF+%7C+Digital+tools+and+remote+visits.jpg&parentUrl=https://osf.io/q7vgp/&format=2400x2400.jpeg [3]: https://mfr.de-1.osf.io/export?url=https://osf.io/uerp7/?direct%26mode=render%26action=download%26public_file=False&initialWidth=758&childId=mfrIframe&parentTitle=OSF+%7C+Digital+tools+and+remote+visits2.jpg&parentUrl=https://osf.io/uerp7/&format=2400x2400.jpeg