Understanding Oncology Studies
Oncology is an area of medicine and clinical research that focuses on the study, treatment, prevention, and management of cancer. Within this field, oncology studies play a critical role in advancing knowledge and improving patient care.
Like other therapeutic areas of research, oncology treatments undergo testing in clinical trials. Oncology studies have advanced the effectiveness and safety of cancer therapies, providing hope to millions of cancer patients worldwide.
Oncology is a complex therapeutic area often more intricate than other fields of medicine. Due to this complexity, oncology studies follow specialised protocols and require careful monitoring compared to clinical trials in other medical areas.
What are oncology clinical trials?
Oncology clinical trials are research studies that investigate cancer, aiming to answer questions such as how to treat cancer, how to prevent cancer, and how to improve patients’ quality of life.
These trials are a central component of oncology studies, helping to translate scientific discoveries into practical treatments.
Endpoints of oncology studies include:
- Cancer treatment
- Cancer prevention
- Cancer diagnosis and screening
- Managing symptoms, side effects, and quality of life
Each different trial design in oncology is intended to answer unique questions that will help improve the lives of cancer patients and advance medical knowledge. Oncology studies are distinct for other therapeutic areas in several ways, reflecting the complexity of cancer as a disease and the challenges of clinical research in this field.
How do oncology studies compare to other therapeutic areas?
Oncology clinical research differs from other therapeutic areas in a number of ways, including:
1. Researching multitudes of diseases
One of the most significant differences in oncology studies is that cancer is not just a single disease but many different conditions. Types of cancer can include lung cancer, breast cancer, kidney cancer and many more.
Clinical research has also identified many subtypes of cancer, whereby particular cancers can form through different tumorigenesis (tumour development) processes. For example, lung cancer is recognised in two general forms, non-small cell and small cell lung cancer, and even in different molecular forms beyond these two types.
This makes oncology clinical trials particularly complicated in comparison to other therapeutic areas. Researchers are not investigating just one type of disease, as it can take many forms. This can also present challenges in chemotherapy drug development, and particular considerations in early-phase oncology trials
2. Different efficacy endpoints
Another main difference between oncology clinical trials and other therapeutic areas is that oncology trials often involve different efficacy endpoints.
Efficacy endpoints are the measurable outcomes of a trial. Common efficacy endpoints in clinical research measure whether the drug has effectively treated the condition in human participants. For example, how well an antibiotic fights against an infection.
In oncology studies, however, endpoints may also focus on extending patient survival or improving quality of life. Some clinical trials on oncology aim to reduce the impact of treatment side effects – this is the aim of many translational research studies.
As mentioned, cancer is an extremely complex therapeutic area. Whilst there has been significant progress made in developing effective cancer treatments, there is still some way to go until cancers are fully treatable. Therefore, it is important that patients experience a good quality of life and that the effects of cancer and its treatments are reduced.
3. Different comparator drugs
In the typical clinical trial process, a placebo is used in place of the treatment to measure the effectiveness of new development therapies in comparison. However, this is not the case in oncology clinical trials.
When a standard therapy exists, this is used as the control treatment that is measured against the new development treatment.
Where patients are administered a placebo treatment in oncology studies , this is given in conjunction with other standard treatments. It is important that patients’ standard treatments are not disrupted by the trial, as this could be potentially life-threatening.
4. Different measures of adverse events
In non-oncology studies, adverse events are measured as mild, moderate or severe. However, in oncology clinical trials, adverse effects are measured using a unique grading system, which rates events from 1 to 5 depending on severity.
These guidelines are administered by the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE). These oncology-specific guidelines classify adverse events as follows:
- Grade 1 – classifies mild adverse events
- Grade 2 – classifies moderate adverse events
- Grade 3 – classifies severe adverse events
- Grade 4 – assigns life-threatening or disabling adverse events
- Grade 5 – assigns death-related adverse events
The full criteria may not apply to all adverse events. For example, iron overloads are classified as level 2 adverse events at a minimum, whereas events including tinnitus and vertigo are only classified as high as level 3.
5. Patient recruitment
Patient recruitment can be more of a challenge in oncology clinical trials. Fewer than 5% of adults with cancer are reported to participate in cancer clinical trials. Several factors make recruitment more difficult:
- The implication of viewing cancer as a disease with specific subtypes is that there are smaller patient sample groups available to participate in the trial, since it is harder to find patients that share matching molecular profiles.
- Oncology studies often require more test sites in order to account for population requirements.
- Cancer patients may have debilitating symptoms that make travel to distant test sites more difficult.
- Precision medicine requires very specific biomarkers, reducing the number of eligible participants.
- Multiple trials in the same region often compete for the same patient population.
- Complex trial protocols can lead to higher dropout rates.
Whilst more test sites are necessary to support patient recruitment, this can increase the trial’s costs quite significantly. The challenges involved with oncology patient recruitment can lengthen the period of the trial by months or sometimes years. This can make it more difficult to retain financial support from sponsors of the trial.
6. Operational Complexity and Costs
Oncology is one of the most resource-intensive areas of clinical research. Trials typically last longer (up to 12 years), compared to non-oncology drug development (8 years).
Reasons for higher costs include:
- Complex protocols and more procedures.
- Intensive monitoring of oncology clinical trials, especially in early phases where safety risks are highest.
- Larger amounts of data collected (over 3 million data points per protocol in Phase II).
- Need for specialist staff, such as Clinical Research Associates (CRAs) with oncology expertise, who command 20-50% higher rates than non-oncology CRAs.
These factors mean oncology research requires significant investment but also has the potential for high patient impact.
7. Oncology clinical trial design
Oncology can be a highly challenging area of research. To overcome the potential challenges in oncology research, it is important to plan accordingly with an effective clinical trial design.
Oncology Clinical Trials Success Rates
Recent research published in the National Library of Medicine found that only 49.1% of cancer clinical trials successfully met their enrollment goals, down from over 52% a decade ago. This trend highlights the growing challenge of patient recruitment in oncology, driven by factors like increased trial complexity and narrower patient criteria. Trials with multiple sites and clearly defined endpoints were more likely to succeed. At Simbec-Orion, we factor these insights into our trial designs to support better recruitment outcomes from the start.
Clinical Trials at Simbec-Orion
At Simbec-Orion, oncology is one of our core areas of expertise. In the last 5 years, Simbec-Orion has been involved in 45+ oncology studies. We specialise in developing bespoke clinical trial designs that address the unique challenges of oncology research. Our team manages every aspect of the trial process, from initial planning and patient engagement strategies to endpoint definition and trial execution.
We offer full-service clinical trial management, including patient recruitment, site management, and data processing. With a focus on oncology and rare diseases, our customised clinical development solutions are tailored to meet the specific requirements of each study.
With 50 years of experience as a CRO, Simbec-Orion collaborates with clients across the globe, functioning as a true extension of their teams. Our goal is to ensure each clinical trial is efficiently managed and delivers meaningful outcomes.
Learn more about oncology trials at Simbec-Orion