Late last year, R&D benchmarking experts KMR Group released a study finding oncology clinical trials were taking longer to complete. After the operational aspects were assessed, the report found enrolment and treatment processes had both increased by six months, with treatment duration doubling since 2003.
Over a ten year span, over 4100 oncology trials were analysed, studying industry data from 32 pharmaceutical companies. In general, trial duration in Phases II and III have increased the most with Phase II trials taking a year longer to complete today compared to a decade ago. On the other hand, Phase III oncology trials now last almost five years compared to an average of 3.5 years in trials started in 2003 to 2005.
As oncology trials become more and more complex, it is important to ask the question: Why are oncology clinical trials taking longer?
There are a variety of causes, chief among them, are increasing protocol complexity and trial design, longer treatment periods, and an increasing number of subjects involved. Additionally, more factors are now being tested in trials than ever before, such as biomarkers, multiple diseases, and multiple endpoints.
So what are the solutions that could solve this ever increasing problem? Here are five potential solutions:
Taking a more patient centric approach - to make the best of increasing trial times, it is crucial clinicians engage more with patients to present enough tangible data. At the moment, pharma companies are testing a variety of new methods to engage with patients, such as by creating clinical apps that enable physicians to interact with patients. Adopting such a strategy may be more time consuming as oncology trials, by their nature, can last years. However, it is more cost-effective and could avoid study design challenges, improving the oncology trial process.
Involving patients in protocol development - With sponsors and CROs also working to obtain more and more data from oncology trials, trial processes are becoming even more thorough. According to a Tufts CSDD study into protocol design change, changes in clinical trial protocols across the board are placing greater strain on sites to deliver. This in turn has been found to have a negative impact on clinical trial performance. By involving patients and simplifying protocol designs, the burden placed on oncology trial sites are eased, improving trial duration.
Looking at site performance before study start-up - Site selection is crucial in ensuring a successful oncology trial. A number of factors need to be considered, such as the geography and location of the study. Equally important is establishing your target patient population as that will help narrow down locations that are suitable to run a trial. But most important of all, the site must have sufficient resources so oncology trials are carried out efficiently.
Social media - As previously mentioned, patient recruitment is sticking point for clinical trials across the spectrum and costs pharma companies large amounts of money. The growing presence of social media in today's age means companies have a cost-effective way of recruiting patients online. To keep costs down and speed up the recruiting process, pharma companies must make the most out of social media.
The role of the caregiver over the patient - Studies have shown that when a cancer patient has a caregiver, they are more likely to adhere to trial protocols. With patient retention rates a cause for concern, caregivers play an increasingly important part in oncology trials. Not only are they a source of support through which patients can depend, they encourage them to stay the course. If fewer patients dropout, more trials can proceed without costly delays.