REACTING TO A PANDEMIC
Including local general practitioners, safety labs and community centres as satellite centres, or even just to provide support to main clinical sites, should also be considered in oncology trials. This would reduce patient travel and bring clinical trials closer to patients’ neighbourhoods. Medication could be delivered to patients’ homes where possible, depending on local regulations, route of administration and type of medications. For patients, self-administration is a possibility, although this may be challenging and costly in terms of approvals and the additional resources required to monitor and follow up for accountability and compliance. COVID-19 has opened up a door for the faster entry of tools and methods supporting virtual and decentralised patient-centric trials. New advanced technology, tools and services had been slowly finding their way into clinical trials, but with COVID-19 the whole process was stimulated and accelerated, so there will be a one-way street for many from now on. Traditional or conventional oncology clinical trial conduct may still be present in early oncology study phases because of a small patient sample size or specific sponsors needing to be present in this environment, for example. But also as a consequence of limited resources and a restricted budget that many start-up biotechs may face in the early stages while expecting pivotal/signal results and refinancing. Many of these proven technologies may now be used in hybrid clinical trial models, where each sponsor will find a way to apply technologies that have proven benefits, while also maintaining a conventional approach. New technology is still expensive, and it is likely that you will be overseeing and managing a selection of different providers with different solutions
“Athough remote monitoring has been present for some time now, and has increased during the pandemic, in certain settings, like early oncology phases, there will be a need to have a bigger portion of on-site monitoring performed”
during a full virtual trial. Decentralised trials do not necessarily need to include new technology, but the cost will also increase if a patient is placed in a satellite centre, where all services are brought directly to them.
What long-term changes are likely to be embedded into oncology trials as a result of the pandemic?
The pandemic crisis resulted in outstanding thinking in the search for solutions to overcome great challenges. Some of these ideas will certainly be maintained and implemented in the normal course of study in future times. • In general, better back-up study planning will have to be implemented from the beginning, incorporating crisis scenarios like the one caused by the pandemic.
• Although remote monitoring has been present for some time now, and has increased during the pandemic, in certain settings, like early oncology phases, there will still be a need to have a bigger portion of on-site monitoring performed. The pandemic showed that remote monitoring can be sufficient to run or retain clinical trials. However, to be completely confident in the full set of results, physical site visits and direct insight into documents and processes would need to be included.
• Clinical study protocols must be efficient, but allow certain flexibility in study design, outcomes, and patient visits for required assessment, but without causing protocol deviations. Ideally, a decentralised patient approach must always be considered to reduce oncology patient travel to clinical sites outside the scope of their regular standard of care.
| 11
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50
