Cancer is a leading cause of death globally, but the more we understand about this complex group of diseases, the more opportunities we have to target it with new therapies. Running an oncology clinical trial can be challenging; here are three tips to help you succeed.
In the dynamic clinical trials industry, more and more small biotechs as well as multinational pharma companies are developing new approaches that they’re taking into clinical trials, with the hope of helping cancer patients. Between 1999 and 2021, there were more than 104,000 clinical trials registered for malignant neoplasms (cancer) in the WHO International Clinical Trials Registry Platform (ICTRP).
No two cancer trials are the same, and each comes with its own challenges that depend on the type of cancer, the treatment on trial, and the size, location and complexity of the trial. But in general, oncology trials can be expensive, lengthy, high-risk and difficult to get through approvals.
With 20 years of experience working on oncology trials, we at Siron Clinical have a deep understanding of how to navigate these complex trials and overcome the challenges they pose for sponsors and investigators. Here we share three tips to help you succeed with your oncology trial.
Plan with the risks in mind
One of the ingredients for success with a clinical trial is to be aware of – and plan for – the risks. For oncology trials, it’s important to think about many factors, including administration and people.
On the administrative side, funding and regulatory requirements are prerequisites to getting a trial up and running. To ensure this goes smoothly, you need to strike a balance between minimizing the time it takes to prepare a trial and rushing things. As Ellipses Pharma chief medical officer Dr Hendrik-Tobias Arkenau noted, rushed decisions can lead to protocols being rejected or delays to trial initiation.
On the human side, it’s vital to know who your target patients are to plan participant recruitment and enrolment with your goal in mind. Enrolment is one of the biggest challenges you might face when running an oncology trial, especially since these trials can be large and involve many participants in various locations.
One way to ensure you maximize the success of your recruitment is to put people at the center of the trial from the moment you start to plan. Ideally, this means listening to the people you wish to recruit about their needs and wishes, as well as looking at study considerations like exclusion criteria and logistical factors such as location.
Work effectively with regulators like the FDA
Regulation is a core consideration of every trial. In the USA, where there are almost 20,000 oncology trials underway as of November 2022, the FDA not only sets out the requirements for clinical trials but also offers guidance for meeting them.
In the workshop “Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups,” the FDA shared tips on how to work with them to avoid pitfalls when running an oncology trial. According to a report by Premier Consulting, the FDA advised sponsors to meet with them in advance and to take advantage of opportunities to interact throughout the approvals process. The report highlights that “interacting with the FDA with a non-adversarial approach can go a long way.”
The formal pre-IND meeting is the key moment to interact with the FDA, and as a sponsor, you only have one opportunity to do this. The FDA recommends being prepared to get the most out of it, which includes, for example, identifying the clinical candidate, having a plan for the non-clinical program, and having a plan for the clinical trial that includes details like the patients you want to include and the dose you want to use.
Build a strong team of experts
A good team is vital for success in a clinical trial. Depending on your setup and plans, this might mean recruiting new employees, working with those who are already on the team, or hiring external experts. And if the trial is multi-site or multinational, this can involve a complex management process.
Whatever approach you take to building the team, one key element will be making sure everyone knows what their role is in the trial. This can be done with an effective training program, which is designed to meet the needs of the people on the team.
It’s important to remember you don’t need to do everything in-house. A complex oncology trial will often require external support from a CRO with experience with local and international regulations, running large trials and working side-by-side with study teams. At Siron Clinical we have supported many oncology trials over the last two decades, and the sponsors have benefited from our CRAs’ extensive knowledge and experience.
Contact us to find out how Siron Clinical can support your oncology trial.