Clinical trials have changed drastically over recent decades. Increasingly, trials are going global, and the COVID-19 pandemic has been a catalyst for the utilisation of remote monitoring and telemedicine. But different therapy areas present different challenges, and oncology has always faced numerous obstacles, from patient recruitment to procuring medications on time.
According to a Global Oncology Trends study from the IQVIA institute, a record number of new oncology drugs were launched in 2018. However, clinical trial duration remains higher for oncology trials than any other disease area and while the overall productivity of oncology trials improved by 22% between 2010 and 2019, it still remains far lower than trials for other therapy areas.
So, what is contributing to these complications, and how can oncology trials adapt?
According to Ian Hoban, business development director at Aposave, part of the problem is failure to account for increased complexity around sourcing oncology medications: “Typically you would carry out a placebo-controlled trial to get your product authorised and demonstrate that your product is better than no treatment/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 we want the new product to be compared against. So it’s not just about sourcing the key biologic reference medicine.
“For many common tumours and cancers, you typically need to have a variety of different products for the treatment regimen. Over the years, oncologists have developed different mixtures that appear to work better for certain types of tumours, so you’ve also got to consider when you’re starting your trial that you might have to source several oncology medicines, rather than just one specific drug.”
Further issues are found when it comes to oncology patient recruitment. In fact, approximately 3% of cancer patients participate in clinical trials despite so many being conducted. That means high levels of competition when it comes to finding eligible patients. Delays due to medication procurement push trial timescales further back and makes patient recruitment even more difficult.
“A key challenge is persuading the people who designed the trial to build in flexibility, both at protocol level and local regulator level to make sure you’ve got a variety of options available,” Hoban explains. “You’re unable to recruit patients while you’re waiting to update your protocols if you need to seek out alternative medication sources. This is because of a shortage or break in supply of a key medicine, so it is better to have contingency options built in from the onset.”
“A lot of oncology studies are evolving as a result of increasing protocol complexity/trial design, numerous endpoints, increases in the number of subjects required, and longer treatment periods. A clinical trial sponsor’s comparator and standard treatment sourcing strategy needs to reflect this in order to address these challenges.”
Aposave has unparalleled access to real-time data relating to the availability of medicines and key specialty brands. Using powerful analytical tools, the company provides clinical trial sponsors with comprehensive, robust sourcing options so they are prepared for shortages.
Building on its relationship with parent company Abacus Medicine, Aposave has access to a rolling inventory with 1000’s of stock-keeping units of specialist medicines. This ability is especially important when the availability of generic oncology medication has become increasingly unreliable in different markets.
In addition, Aposave has strong relationships with a variety of generic manufacturers, offering clients both reliability and credible back-up options.
Governments and private companies alike are working together to help find ways to prevent and treat cancer. To find out more about how Aposave can solve supply issues and reduce waste during oncology clinical trials, download the whitepaper below or visit their .