With the high severity and more significant contagion effect, this pandemic has already negatively impacted the current ecosystem of clinical trials as a whole. The eligibility and ability of participants to enter in clinical trials is affected as visits are constrained by quarantine measures and travel restrictions.
While the concept of virtual trial is not new and dates back to 2011, when Pfizer conducted the first ever randomized clinical study that managed participants using mobile phones and the internet, the approach towards virtual mode of conducting clinical trials had faded away. This was partly due to limited success stories and high capital investments required for technological infrastructure to deliver such trials. However, with COVID-19 delivering a punch in the face of on-going and planned studies, the future of decentralised (remote or virtual) clinical trials has rapidly become imperative.
Where the average cost of developing a drug and bringing it to the market can be estimated to be as high as $2.6 billion (two-thirds of the cost going to clinical trials), about 90% of them fail. The advantages of these virtual trials are not limited to cost savings but:
- Can help recruit globally, no limits on their available patient population using technologies such as electronic questionnaires, electronic consent, videoconferencing & telehealth, micro sampling & home kits for testing, mobile devices & wearables to collect remote patient data and drug delivery by post
- Can overall be more time efficient and cost effective, resulting in high patient retention and maximized enrolment
With advantages, however, also come some barriers and virtual clinical trials are no exception and hence regardless of these potential benefits, of the >90,000 active clinical trials listed on ClinicalTrials.gov (as at Nov 2020), only 55 digital efficacy endpoints are currently being used in industry-sponsored trials of new medical products. The various reasons to this barrier can be:
- Data protection laws and requirements are tightening everywhere, and there are definitely concerns about the sharing of patients’ personal and biometric data over the internet
- Siteless trials mean (mostly) no medical staff, so patients are responsible for receipt and storage of IMPs, dosage adherence, and entering and (often) transmitting their own data at the right intervals; that is a lot of trust usually placed on trained medical staff, now placed on a patient
- Several technical issues, e.g. what happens if a drug product needs to be refrigerated but the patient’s home has a power cut? What happens if a wearable suffers a technical malfunction?
These disadvantages / barriers of adopting virtual clinical trials however are being looked at under a different light now. Due to stay-at-home orders and fears of COVID-19 transmission, more than 1,500 clinical trials across the U.S. and Europe have been disrupted since May 2020. This can take a toll on R&D costs, patients’ lives etc.
A decentralized clinical trial model is therefore likely to be the new normal for a large number of trials but not necessarily a complete alternative to the traditional on site mode. The virtual model might still not be a good fit for Phase I trials, which focus on patient safety, or trials that treat acute health problems like stroke, or those that require complicated measurements, like a brain scan or MRI.
The above boil down to the fact that Pharma companies need to be prepared to adopt the new normal without saying, “we can’t” but “how can we do it”. Inevitably, this new normal calls for:
- A tailored or customizable approach and potentially a hybrid model where the trial design can be both on-site and virtual
- Pharma companies upgrading their technological infrastructure
- All stakeholders prioritizing collaborations
Sources:
https://www.veristat.com/virtual-clinical-trial-adoption
https://www.clinicalleader.com/doc/steps-to-get-a-virtual-clinical-trial-up-and-running-0001
https://www.volitioncapital.com/news/virtual-clinical-trials-the-future-of-healthcare-research/
https://www.nature.com/articles/d41573-020-00094-0
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