Clinical Trials – The future of Oncology trials.

Clinical trials have changed dramatically in recent decades and the COVID-19 pandemic is a catalyst for remote monitoring and telemedicine use.

Clinical trials have changed dramatically in recent decades. Increasingly, testing is being conducted worldwide, and the COVID-19 pandemic is a catalyst for remote monitoring and telemedicine use. However, different treatment areas have different challenges, and oncology has always faced many obstacles, from recruiting patients to procuring medicines on time.

A record number of new oncology drugs were launched in 2018, according to a study by the IQVIA Institute’s Global Oncology Trends. However, the clinical trial duration of the oncology trial was longer than in any other disease area, and the overall productivity of the oncology trial increased by 22. The percentage between 2010 and 2019 remains much lower than in trials in other therapeutic areas.

So what are the causes of these complications and how can oncology trials be adapted?

According to Aposave’s director of business development, Ian Hoban, part of the problem is that it cannot explain the increasing complexity of procuring oncology drugs. “Usually, placebo-controlled trials are performed to approve the product and demonstrate that the product is superior. Than no treatment / placebo.

“In an oncology exam, it’s It is rarely allowed. The untreated group means that the patient has a poor prognosis or has a significantly shorter life expectancy. Whatever the standard treatment for a particular tumor or stage of cancer, it is compared to the new product. Therefore, it is not just about procuring important biological reference drugs.

“For many common tumors and cancers, it is usually necessary to have a variety of different products for treatment planning. Over the years, oncologists have been more effective against certain types of tumors. We have developed various mixtures that appear to work with us, so we need to consider that we may need to procure multiple oncological drugs, not just one, when starting the study. There is a medicine.”

Participation issues

There are additional issues with oncology patient recruitment. In fact, despite the large number of cancer patients, about 3% of cancer patients participate in clinical trials. This means a high level of competition when it comes to finding qualified patients. Delays in drug procurement further delay the timescale of trials and make patient recruitment even more difficult.

“The key challenge is to convince people who designed the trial to incorporate flexibility at both the protocol level and the local regulatory level so that different options are available,” Hoban explained. To do. “If you need to find an alternative medicine source, you cannot recruit patients while waiting for a protocol update. This is due to a shortage or lack of supply of major medicines, so it is urgent from the beginning. We recommend incorporating time-sensitive options. “

“Many oncology studies are evolving as a result of increased protocol complexity / study design, numerous endpoints, increased number of subjects required, and extended treatment duration. To address these challenges. In addition, clinical trial sponsor comparators and standard treatment sourcing strategies need to reflect this.“


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