How are Oncology Clinical Trials Different from Other Therapeutic Areas?
Oncology is an area of medicine and clinical research that focuses on the study, treatment, prevention and management of cancer.
Like other therapeutic areas of research, oncology treatments undergo testing in clinical trials. Clinical research in oncology has advanced the effectiveness and safety of cancer therapies, providing hope to millions of cancer patients worldwide.
Oncology is a complicated therapeutic area that can be somewhat more complex than other areas of medicine. As a more complicated area of medicine, oncology clinical trials often follow different formats to other trials.
Oncology trials are unique in a number of ways. From often having unique endpoints, measures of adverse events and challenges in patient recruitment.
This article discusses how oncology trials are different from other therapeutic areas, and the many factors that make oncology research so unique. You might also be interested in our webinar: Precision Oncology: An Era that Calls for a New Model for Conducting Clinical Trials?
What are oncology clinical trials?
Oncology clinical trials are research studies that investigate cancer, answering questions such as how to treat cancer, how to prevent cancer and how to improve patients’ quality of life.
Trials are used to investigate several endpoints in oncology research:
- Cancer treatment
- Cancer prevention
- Cancer diagnosis and screening
- Managing symptoms, side effects and quality of life
Each different trial design is intended to answer unique questions that will help improve the lives of cancer patients and advance medical knowledge.
How does oncology compare to other therapeutic areas?
Oncology clinical research differs from other therapeutic areas in a number of ways. Most notably, cancer is understood as many diseases, not just one. For instance, types of cancer can include lung cancer, breast cancer, kidney cancer and many more.
Clinical research has also recognised 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 just investigating one type of disease, as it can appear in so many forms. This can also present challenges in chemotherapy drug development.
Additionally, the effects of cancer, and its treatments, can cause particularly debilitating effects on patients. As a result of this, there is a higher proportion of clinical trials that focus on quality of life and improved drug safety endpoints compared to other types of clinical research.
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.
Whilst it is possible for this efficacy endpoint to form part of cancer treatment research, many oncology clinical trials aim to extend or improve patients’ quality of life. Some oncology clinical trials 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.
In the journey to this point, it is important that patients experience a good quality of life, and that the effects of cancer and its treatments are reduced.
It is this need that makes oncology such a multifaceted area of medicine, with a heightened necessity to not only treat the disease, but also manage it.
Different comparator drugs
A key differentiator in oncology clinical trials is the role of 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 trials, 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.
Different measures of adverse events
In non-oncology trials, 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.
Patient recruitment can be more of a challenge in oncology clinical trials. There are several factors that make recruitment more difficult.
Firstly, oncology research has progressed from viewing cancer as one type of disease. Now, researchers investigate specific subtypes to develop more targeted therapies.
The implication of this 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.
Secondly, oncology research often requires more test sites in order to account for population requirements. As well as patient groups being limited in size, cancer patients may have debilitating symptoms that make travel to distant test sites more difficult.
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.
Oncology clinical trial design
Oncology can be a highly challenging area of research. In order to overcome the potential challenges in oncology research, it is important to plan accordingly with an effective clinical trial design.
At Simbec-Orion, we specialise in oncology as a therapeutic area, with expertise in developing tailored clinical trial designs for oncology research. We conduct clinical trial management from start to finish.
From patient engagement strategies, to clearly defined endpoints and challenges, our clinical trial designs are tailored to the unique needs of oncology studies.