**dECMT workshop** As a result of the COVID-19 pandemic there has been a rapid transition to more remote working for all members of clinical trials teams, resulting in an increased use of technology by both sites and sponsors in these trials. This workshop explored some of the changes that have been made along with associated benefits and challenges. The workshop covered a wide range of topics including discussion about the optimal use of these technologies, their strengths, weaknesses, the opportunities they afford and also threats that may hinder their progress and implementation. This workshop was led by: - Dr. Donna Graham: Medical Oncology Consultant in the Experimental Cancer Medicine Team at The Christie Hospital in Manchester and Honorary Clinical Lecturer at University of Manchester. Technology Clinical trials lead for dECMT and Work Package 1 lead on CRUK UpSMART digital Accelerator award - Dr. Alastair Greystone: Medical oncologist at the Newcastle ECMC with a special interest in the development of new anti-cancer drugs for patients with thoracic malignancies. Joint Chief Investigator of the CONCORDE platform, Clinical Lead for Cancer for the Yorkshire, Hull and North East England Genomic Laboratory Hub and leads the Pharmacodynamic Biomarker team at Newcastle University Centre for Cancer - Prof. Richard Wilson: Professor of Gastrointestinal Oncology and an Honorary Consultant in Medical Oncology in the Institute of Cancer Sciences in the University of Glasgow and the Beatson West of Scotland Cancer Centre. Established an early phase cancer clinical trials programme in Ireland, first Clinical Director of the N. Ireland Cancer Trials Network. **Initial presentation: Dr Donna Graham:** - There has been a rapid transition to remote working for all members of the clinical trials team during the COVID-19 pandemic. This has led to a significant increase in the use of technology. - Work by University of Manchester MRes student, Natalie Murphy, surveying sites and sponsors during the pandemic has shown significant increase in telephone visits and videoconferencing for sites (p<0.05) and implementation of remote monitoring and electronic signature software by sponsors. - For sites, the tools that they identified as having greatest possible benefit are to facilitate remote monitoring and remote or eConsent and sponsors noted that EHR with remote access or eSource would be most beneficial. - The General Medical Council have provided a decision flowchart regarding remote consultation and when it is appropriate. https://www.gmc-uk.org/ethical-guidance/learning-materials/remote-consultations-flowchart - The Royal College of Physicians have provided a link to guidelines for remote consultations, including advice on the setup of a video/telephone consultation. https://www.rcplondon.ac.uk/education-practice/courses/effective-remote-consultations - Publication by the Royal Marsden Sarcoma Unit shows high patient satisfaction regarding conversion to telemedicine but almost half of patients wouldn’t want to receive bad news via telemedicine. Clinicians found this method to be efficient with no associated increase in workload. 80% of patients wanted some form of telemedicine as part of their future care. Smrke et al. JCO Global Oncology. 2020. https://ascopubs.org/doi/10.1200/GO.20.00220 - Remote consent is an important area for future development. A robust processes may suffice with existing software and sharing of accepted processes may permit this. Discussion with sponsors is required regarding agreement of processes. - CRUK accelerator award: UpSmart programme: awarded to a consortium of Early phase clinical trial sites across the UK, Italy and Spain to accelerate deployment of digital healthcare technologies to these European experimental cancer medicine centres. Aims to provide centres with baseline digital infrastructure to conduct clinical trials of new digital healthcare technologies. **Summary**: COVID-19 has caused a change in how we work within Early Phase Clinical Trials. Technology implementation by healthcare providers is occurring at a more rapid rate than ever before. We need to guide best practice and ensure that technology is used appropriately for the benefit of patients on Early Phase Clinical Trials. Collaborating and sharing examples of challenges and solutions may help to facilitate this. **Workshop Discussion: Discussed pros and cons of virtual consultations:** ![enter image description here][1] **Electronic health records/prescription systems:** - There is still a need for interoperable systems allowing ease of access to different systems and facilitating collaborative working across the NHS. - A method of saving data from electronic health records in a standardized data format would allow anonymised data sharing across the UK. - Many of these systems are already established but hard to integrate: the CRUK-funded UpSmart programme hopes to assess methods of addressing this. - Data security, remote access verifications, security and governance are all issues that must be considered when developing these systems and in their interactions. The session chairs compiled a strengths, weaknesses, opportunities and threats (SWOT) analysis chart, based on both their own experiences and audience feedback relating to implementation of digital and remote tools in early phase trials and consultations: ![enter image description here][2] [1]: https://mfr.de-1.osf.io/export?url=https://osf.io/t7z3g/?direct%26mode=render%26action=download%26public_file=False&initialWidth=692&childId=mfrIframe&parentTitle=OSF+%7C+Pros+and+cons+of+virtual+consultations.jpg&parentUrl=https://osf.io/t7z3g/&format=2400x2400.jpeg [2]: https://mfr.de-1.osf.io/export?url=https://osf.io/uswe6/?direct%26mode=render%26action=download%26public_file=False&initialWidth=686&childId=mfrIframe&parentTitle=OSF+%7C+ECMC+North+IT+workshop+discussion+slides.jpg&parentUrl=https://osf.io/uswe6/&format=2400x2400.jpeg