Cancer is a complex disease that affects millions of people around the world. In recent years, we have seen remarkable progress in both our knowledge of cancer’s biological mechanisms and the discovery of effective new treatments, with clinical trials remaining essential to advancing cancer research and getting new treatments to patients.
Today’s clinical trials in oncology typically focus on investigating the safety and efficacy of new cancer treatments, such as drugs, immunotherapies, and gene therapies. These studies are divided into several phases, with each phase designed to answer specific questions about a treatment’s safety and efficacy. However, the rise of novel treatment approaches may signify an entry into a new era of cancer treatment and oncology trials, with precision medicine, combination therapy, and real-world evidence at the forefront.
How oncology trials differ from other clinical trials
In general, phase I oncology trials are the first step in testing new cancer treatments. These studies evaluate the safety of a new treatment and determine the appropriate dosage to use in future studies. Phase II trials assess the treatment’s efficacy concerning a specific type of cancer, while phase III trials compare the new treatment to the current standard of care.
Yet due to the inherent unpredictability of cancer, oncology trials differ from other clinical trials in a number of ways, including the need for longer follow-up periods, the inclusion of multiple treatment arms, and the implementation of specialized study designs to assess subsets of patients with particular types of cancer.
Challenges facing oncology researchers
The main challenge facing oncology researchers is the diversity of cancer types and subtypes. Due to their distinct biology and variable responses to treatment, all cancer types are individually challenging to tackle. Moreover, cancer cells can undergo mutations that render them resistant to therapies, making it difficult to develop agile and permanent solutions within the constraints of clinical trial sites.
Increasing participant diversity in oncology trial enrollment is another significant challenge. Researchers need to figure out how to make participation in clinical trials feasible for all patients, not just the privileged few who can afford to travel to convenient locations, in order to validate trial results across all demographics.
New approaches to oncology treatment and trials
To address these challenges, researchers have been exploring new approaches to cancer treatment, such as precision medicine. This method involves tailoring therapies to individual patients based on their unique genetic and molecular profiles. By analyzing the genetic mutations present in a patient’s cancer cells, researchers can identify specific targets for treatment and develop personalized treatment plans.
One precision medicine approach that has shown great promise in clinical trials is CAR T-cell therapy for the treatment of cancer. In this treatment, the patient’s own T-cells are genetically modified to recognize and destroy cancer cells. The modified T-cells are reintroduced into the patient, where they proliferate as they look out for — and kill — cancer cells. CAR T-cell therapy has been studied as a potential treatment for other cancers as well, and has shown remarkable success in treating certain types of blood cancers such as leukemia and lymphoma.
This approach has the potential to improve patient outcomes while reducing the side effects associated with traditional chemotherapy and radiation therapy. Furthermore, precision medicine has the potential to identify new targets for cancer therapy and improve our understanding of cancer’s still-unpredictable nature.
Another area of active research is the development of combination therapies. When treating cancer, it is common to use therapies that involve the use of more than one drug, to attack the disease from different angles. These therapies can include chemotherapy, radiation therapy, immunotherapy, and targeted therapy.
Combination therapy is based on the premise that by targeting cancer cells in multiple ways, more of them will be killed and resistance will be prevented. As an added bonus, using lower doses of each therapy in combination can lessen the likelihood of unwanted side effects. Combination therapies have shown promise in clinical trials and are becoming an increasingly important approach to cancer treatment.
Lastly, efforts are being made to broaden patient participation in clinical trials, as researchers investigate additional avenues such as real world evidence (RWE) and real world data (RWD).
Traditionally, clinical trials have been conducted at large medical sites, which can be challenging for patients who live far away or have limited resources. To address this issue, researchers are making substantial use of telemedicine, mobile health technologies, and RWD from sources such as electronic medical records, disease registries, and mobile health devices.
As a result, clinical trials can now be conducted in the comfort of patients’ own homes, thanks to these methods and the data they generate about treatment outcomes in the real world, such as patients’ quality of life, disease progression, and overall survival rates. Additionally, by analyzing RWE, researchers can gain a better understanding of the effectiveness and safety of cancer treatments, as well as identifying potential disparities in treatment outcomes based on patient demographics or other factors.
The most revolutionary aspect of RWE, however, is that it can be effectively used to answer research questions that would be too challenging to study within a clinical trial, providing researchers with cutting-edge insights for developing revolutionary cancer treatments without limitation. This ability can accelerate the development of various approaches, including precision medicine, as RWE is used to identify patient subgroups that may benefit from specific treatments based on their genetic or molecular profiles.
The field of oncology trials is dynamic, with new methods of cancer treatment and research constantly being developed to meet the wide range of challenges posed by the disease. Tremendous progress toward better patient outcomes in oncology research can be made through the application of precision medicine, combination therapy, and real-world evidence. These advances are paving the way for a new era of cancer treatment, with the hope of more effective, targeted therapies and better outcomes for patients worldwide.
At Clinixir, we offer industry-leading services to help your organization develop better, safer, and more advanced treatments. Clinixir researchers have excellent experience enrolling, managing, and caring for participants. Our clinical expertise, state-of-the-art methods, and cutting-edge technologies will enable your organization to put reliable drugs and treatment methods on the market, providing a better quality of life for the general public.
If you’re looking to conduct clinical trials, contact us today to get started.