Oncology is a branch of medicine that focuses on diagnosing, treating, and preventing cancer. Cancer is a complex disease that requires extensive research and clinical trials to develop effective treatments.
Oncology clinical research involves the study of cancer in human participants through clinical trials. These trials aim to determine the safety and efficacy of new cancer treatments and improve overall cancer care. Oncology clinical research involves various stages, from study design to publication, and requires the involvement of multiple stakeholders.
In this post, we will provide an overview of oncology clinical research and its importance in advancing cancer research and treatment.
Why Does Oncology Clinical Research Matter?
Oncology clinical research is critical for many cancer patients and their loved ones, as it enables new drug development. In addition, clinical research may assess current cancer therapies and discover ways to improve their effectiveness or safety.
The goals of oncology clinical research can vary, ranging from improving cancer prevention, early diagnosis, and healthcare screening, as well as managing cancer-related symptoms and improving patients’ quality of life.
Another important goal of oncology clinical research is to advance how we treat cancer and identify new targets for treatment, such as specific cell receptors or mutations.
Oncology clinical research is also essential because cancer is a significant global health challenge, affecting millions of people worldwide. In 2020 alone, around 18 million cases of cancer were diagnosed, with around nine million men and approximately nine million women being affected.
Clinical research can ultimately help reduce the global burden of many cancers.
These can include:
- Breast cancer
- Colorectal cancer
- Lymphoma
- Prostate cancer
- Pancreatic cancer
- Melanoma
- Sarcoma
By conducting oncology clinical research, researchers can identify treatments that are more effective and have fewer side effects, as well as optimize the use of existing treatments. In the end, an oncology research program aims to improve cancer outcomes, such as survival rates and quality of life.
What Are the Types of Oncology Clinical Trials?
Cancer clinical trials play a vital role in cancer research and help answer various research questions that aim to benefit people with cancer in different ways. There are several types of clinical trials, including screening trials, treatment trials, prevention trials, supportive care trials, and natural history studies.
Screening Trials
Researchers conduct screening trials to assess new methods of finding a certain type of cancer early. The results of a screening trial may help decrease the risk of death depending on the cancer being screened.
Screening trials can help answer whether early cancer detection through screening increases patients’ chances of survival, which screening method is superior, and whether patients who undergo the screening test are more likely to receive unnecessary follow-up procedures.
Treatment Trials
Treatment trials test new treatments or new ways of using current treatments, including medications, surgery or radiation therapy, and a combination of treatments.
Treatment trials aim to determine the safe dosage of a new treatment, how the new treatment should be given, and whether the new treatment can extend the life of patients. These trials can also determine whether the new treatment simply shrinks tumors or prevents them from growing, as well as identify any side effects.
Prevention Trials
Cancer prevention trials are designed to evaluate ways to reduce the risk of developing cancer in healthy individuals who are at a high risk of the disease. There are two types of prevention trials: agent studies and action studies.
Agent studies test whether taking certain medicines, vitamins, or dietary supplements can reduce the risk of developing a certain type of cancer. Action studies, on the other hand, examine whether adopting specific behaviors, such as exercising more or consuming certain foods, can lower the risk of developing cancer.
Supportive Care Trials
Supportive care trials, also known as palliative care trials, focus on improving the quality of life of cancer patients, especially those who may experience side effects from medications. These types of trials can help discover new methods of managing pain, sleep problems, nausea, infections, and mental health problems, among other issues.
Natural History Studies
Natural history studies follow people with cancer or those at high risk to collect data over a certain period. Through these studies, researchers can analyze the growth and spread of cancers, cancer-causing genes, and clues to prevent or treat cancer.
Participants in these research studies may need to provide tissue samples or other biospecimens to a cancer center throughout the study period.
What Are the Phases of Oncology Clinical Trials?
Phase I trials are the first step in testing a new drug or treatment. They are usually small studies that involve a small group of people.
The goal of a phase I trial is to determine the safety of the treatment, the best dosage, and the most effective way to administer the new treatment. Through these trials, researchers can identify potential side effects and establish the maximum safe dosage for the next trial phases.
In phase II trials, researchers study the effectiveness of a treatment in a larger group of patients, usually several hundred. These trials also continue to evaluate the safety of the treatment and determine any side effects that may occur.
The goal of phase II trials is to determine whether the treatment is effective for the disease being treated. Researchers also assess the most effective dose and the best way to administer it.
Phase III trials are large studies that involve thousands of patients and are designed to compare the new treatment with the current standard of care. These trials are usually randomized, meaning that patients are randomly assigned to receive either the new treatment or the standard of care.
A phase III trial aims to determine whether the new treatment is better, worse, or has the same effect as the standard of care. Phase III trials are the final step in testing a new treatment before it can be approved for use in patients.
Phase IV trials are conducted after a treatment has been approved. They are designed to collect more information about the treatment’s safety and effectiveness, and they’re done in a larger population over a longer period of time.
These trials help researchers and clinicians continue to assess the treatment’s benefits and risks and identify any long-term side effects.
What Is the Oncology Clinical Trial Process?
The oncology clinical trial process involves several stages, from study design to publication. The process is complex and involves multiple stakeholders, including researchers, oncologists, and patients.
In addition, larger organizations, such as regulatory agencies and biospecimen providers, also play a role. Each stakeholder is important for ensuring that clinical studies are successful.
Study design
The first stage of the oncology clinical trial process is study design. In this stage, researchers determine the research question, study population, intervention, and outcome measures. The design of a study can affect the quality of the results and the potential impact of the research.
Patient recruitment and enrollment
The next stage is patient recruitment and enrollment. Patient recruitment can be a challenging aspect of oncology clinical trials. Depending on the goals of the study, researchers need to recruit patients with specific cancer types or other characteristics.
Analysis and Publication
Once patients are enrolled in the study, researchers administer the intervention and collect data. They then analyze the data to determine the safety and efficacy of the intervention. The final stage is publication, in which the results of the study are distributed to the scientific community and the public.
Challenges and Opportunities in Oncology Clinical Research
The oncology clinical research field has its unique challenges and opportunities. One of the most significant challenges is patient recruitment. Oncology trials require a large number of patients, and it can be difficult to find patients who meet the eligibility requirements. This can lead to trial delays and a limited ability to find statistically significant conclusions.
Since cancer is a complex and heterogeneous disease, designing a trial that adequately addresses the research question while balancing safety and ethics can be difficult. If the trial is too strict or doesn’t include all the important factors, the study might not be able to show what it was meant to. This can make the results of the study less useful and harder to apply to real-life situations.
Funding may also be a significant challenge in oncology clinical research. Clinical trials can cost a lot of money to conduct, and getting the money to do them can be hard. This can be particularly challenging for smaller biotech companies or academic institutions with limited resources.
Despite the challenges, there are many opportunities for advancing oncology research.
New technologies, such as liquid biopsy and genomic sequencing, are enabling researchers to identify more precise biomarkers and better understand cancer. In addition, adaptive trial designs and master protocols are being used to streamline the clinical trial process and accelerate research.
Depending on the nature of the study, some researchers may find it more efficient and cost-effective to source tissue samples from an online biorepository such as iProcess. At iProcess, we have biospecimens reflecting a wide variety of demographics, pathologies, and disease progression.
Not only can we help with sample sourcing, but we can also help with the research itself. Thanks to our team of professionals, we have everything needed for a groundbreaking clinical trial.
The Bottom Line
Oncology clinical research is essential for advancing our understanding of cancer and creating effective cancer treatments. Different types of oncology clinical trials are designed to answer specific questions that may improve the quality of life for cancer patients. While cancer research faces challenges, new technologies and approaches offer opportunities to find solutions.
It is important to conduct research in a way that improves cancer patient care. With continued efforts to address challenges and take advantage of opportunities, the future of oncology clinical research looks promising.
By collaborating with stakeholders and prioritizing ethical considerations, we can ensure that clinical trials are successful and advance our knowledge in fighting cancer.
iProcess simplifies the process of obtaining high-quality tissue biospecimens for oncology research studies, offering a quick quote and timely delivery to meet research deadlines. With a selection of samples such as tissues, blood, plasma, serum, urine, stool, and swab samples, we provide everything needed for the next medical discoveries.
Sources:
Types of Clinical Trials | National Cancer Institute
Increasing patient participation in oncology clinical trials | PMC
