Cancer is a leading cause of morbidity and mortality 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 with your clinical operations in oncology trials in Europe.
In 2022, 2.74 million people were diagnosed with cancer in Europe. To address this growing problem, more and more small biotechs as well as multinational pharma companies are developing new treatments 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. In general, oncology trials can be expensive, lengthy, high-risk and difficult to get through approvals. But the benefits are worth the effort: millions of people’s lives could be positively impacted by a new cancer treatment.
With about 25 years of clinical studies experience working on oncology trials, at Siron Clinical we have a deep understanding of how to navigate these complex trials and overcome the challenges they pose for sponsors and investigators. Here we gather insights from our therapeutic expertise and share three tips to help you succeed with clinical operations in oncology trials in Europe.
Plan with the risks in mind
One of the ingredients for success with clinical operations in oncology trials in Europe 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 and EMA
Regulation is a core consideration of every trial and therefore a factor to consider for clinical operations in oncology trials in Europe as well as the rest of the world.
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.
The European Medicines Agency (EMA) fulfils an equivalent role in Europe. In January 2024, the EMA released the sixth revision of its Guideline on the clinical evaluation of anticancer medicinal products, “to provide guidance on all stages of clinical drug development for the treatment of malignancies.”
Build a Strong Team with the Right Therapeutic Areas of Expertise
A good team is vital for success in clinical operations in oncology trials in Europe. 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.
Discover Siron Clinical’s Therapeutic Expertise
At Siron Clinical, we have supported many oncology trials over the last 25 years, and the sponsors have benefited from our CRAs’ extensive expertise, knowledge and experience.
Oncology is one of our therapeutic areas of expertise. As a therapeutic CRO with clinical studies expertise in this area, we have supported sponsors around the world to develop treatments for a range of cancers, including advanced solid tumors, non-Hodgkin lymphoma, and many other cancers including breast, ovarian, and pancreatic.
Our clinical research professionals apply their knowledge in every project to help achieve shared goals and ultimately bring much-needed treatments to the millions of people with cancer in Europe and beyond.
Clinical operations in oncology trials in Europe can benefit greatly from the extensive expertise you access when you work with a CRO like Siron Clinical. Contact us to find out how we can support your oncology trial.
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