Novel drugs and medical devices are absolutely dependent upon the people who volunteer to take part in the trials that test the drug/device’s benefits and risks. Those same people need to also follow the protocol (schedule that outlines what they need to do) each day throughout the trial, and contribute their information. Without this, there will be virtually no new proven medicines, medical devices or novel care pathways. Yet, getting people to consider taking part trials is difficult, with only roughly 3-11% patients actually being given the option of drug-trials and then choosing to get involved1,2. Stephen Walters and his research team3 found that similar recruitment issues are also being seen for medical device trials, with only 56% managing to recruit the number of participants they wanted.
Innovative new trial approaches are urgently needed to control spiralling clinical development costs, the challenge of newer personalised medicines targeting smaller/harder to find populations, and patients themselves asking for trials that they can engage with better. For example, Hala Borno’s research4 identified that their patients needed to travel a median of 26 miles to get in for the frequent hospital visits the trials required – a journey that is both potentially prohibitive, and also potentially risky for cancer patients if public transport is used, bearing current COVID 19 considerations in mind. Indeed, the urgency for virtual trials is further increased in light of the current corona virus/COVID 19 measures being taken and reduced social mobility. These are already causing rapid change in current ongoing trials5.
Virtual trials hold the potential solution. The key question is how to implement them? Many virtual trials that have successfully completed incorporated both ‘traditional’ approaches delivered remotely (e.g. standard tests and feedback delivered through nurse visitation), supplemented with mobile and wearable technologies. Although these are a great way to get started, the limitations of nurse network travel becomes a lesser, but still significant, limitation; and data from mobile technologies needs to be suitable for primary end-points across many therapy areas. As one of our directors shared with PharmaFocus6, there are many considerations that need to be addressed in order to realise the enormous potential of virtual trials. Like all solutions, such novel approaches need to be designed so that every group involved in the delivery-chain sees a benefit to themselves that helps them overcome the innate inertia and pre-existing habits that naturally resist change.
This brings a new wave of challenge to the traditionally paternalistic healthcare model. Although patient and public involvement is becoming more prevalent, it’s not often used as a foundation equivalent to other elements such as science and process-chains. This has to change. The correct implementation of virtual trials affects a whole host of things such as supply chains, processes, care teams, and re-evaluation of regulatory-acceptable study endpoints. It also affects patients and their families. Far from just being viewed as end beneficiaries of the effort – as we move the trial into their home, we need to understand the implications of non-standard environments, behaviours, and the ethics of home sampling for such individuals.
This is where the real journey into virtual trials begins. And it starts with choice – developing the new pathways so that relationships between people are supported and they can decide together how best to deliver and receive care for each individual person. This is an aspect of personalised medicine that can be realised now, but that currently doesn’t exist in the clinical trial world.
We can change this through co-creating solutions that work with those involved, and by bringing together the best of process, technology and scientific methodology from a multitude of fields – including behavioural science. Let’s develop new care pathways that can flex to empower patient’s choices and needs whilst still gathering the information needed for the empirical-testing of new medicines and medical devices. Let’s break this myth that choice equates to cost in people’s minds. It’s time to use scientific methodology to collect the objective data on the difference that personalised delivery of clinical trials makes for key variables such as recruitment, engagement, and data quality outside the hospital.
- Institute of Medicine (US) Committee on Cancer Clinical Trials and the NCI Cooperative Group Program; Nass SJ, Moses HL, Mendelsohn J, editors. A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program. Washington (DC): National Academies Press (US); 2010. 4, Physician and Patient Participation in Cancer Clinical Trials. Available from: https://www.ncbi.nlm.nih.gov/books/NBK220370/
- Simon et al., 2004 https://ascopubs.org/doi/full/10.1200/jco.2004.03.005
- Walters et al., 2017 https://bmjopen.bmj.com/content/7/3/e015276
- Borno et al., 2018 https://www.ncbi.nlm.nih.gov/pubmed/29700209
- HRA guidance https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/covid-19-guidance-sponsors-sites-and-researchers/