IN PARTNERSHIP
Oncology, COVID-19 and clinical trial comparator challenges in 2021
, business development director for Clinical Trial Solutions at Aposave, discusses the impact of COVID-19, the future for oncology trials and the second Annual Survey of Clinical Trial Professionals.
What changes have you seen at Aposave Clinical Trial Solutions (CTS) during the COVID-19 pandemic?
With the outbreak of COVID-19, patients suddenly couldn’t get out of their homes to go to a trial centre for evaluation or to collect medicines. This added a more pragmatic, practical drive to decentralise trials – to keep trials continuing under those adverse challenges. A lot of clinical trials have patients who are immunocompromised and at high risk of an infection really taking hold. I think the hand was forced to a certain extent. Since legislation was passed in 1995,
decentralised clinical trials have been increasingly touted as the future of clinical research. By shipping drugs directly to patients and managing trials remotely through telemedicine, researchers are delivering a truly patient-centric trial right from the patient’s home.
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What are the key differences between oncology and non-oncology trials, and is there a particular challenge you have encountered? Typically, you would carry out a placebo-controlled trial to get your product authorised and demonstrate that it is better than no treatment or a placebo. With an oncology trial, that’s rarely going to be permissible because a no-treatment arm means a patient will suffer a poor prognosis or a significantly reduced life expectancy. Whatever the standard treatment is for a particular tumour, or stage of cancer, that is what the investigational medicine needs to be compared against. For many common tumours and cancers, there are typically a variety of different products included in the treatment regimen. Over the years, oncologists have identified various combinations that work better for certain types of tumour, so an additional consideration when planning your trial is
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