Six Lessons from COVID-19: Running a cancer trials unit during this crisis has highlighted the following. (Remember that cancer has 50% mortality and kills 165,000 people every year in UK - likely more lethal than COVID).
1/6: The MHRA and NHS introduced fast-tracking to get COVID trials up and running quickly. Considering the lethality of cancer and other diseases, this should be the new normal for all clinical studies.
2/6: To minimise the risk of our patients getting COVID, we limited hospital stay time by reducing blood tests. We asked sponsors to review Cmax data and consider clustering PK sampling around peak time points. Should this review be a part of every protocol?
3/6: Video follow-up was effective at assessing toxicity. Patients spend far too long in traffic jams and queues for hospital car parks. All protocols could include flexibility around site of follow-up visits to accommodate pt lifestyle.
4/6: Even our our older patients proved to be tech-savvy. Post COVID: more widespread introduction of wearable devices (fitbits etc) to provide continuous data directly to the sponsor.
5/6: risk:benefit of studies (chance of exposure to COVID versus likelihood of disease progression without treatment) was a major consideration when deciding which studies to continue. Ease of treatment and tox matter++. We need to routinely collect QOL in ph1/2 trials.
6/6: Greater public awareness of the association between lifestyle risk factors and COVID opens the door to wider discussions (and clinical trials) in cancer prevention. Previously under-explored and undervalued area for research.
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