In the last few years, a major breakthrough in cancer research has occurred: early phase oncology trials. This type of trial is designed to test whether a new drug has any adverse effects on people and also provides anecdotal evidence that it might be efficacious. This blog post will discuss the evolving process of early phase oncology trials and how they may change in the future.
The History of Early Phase Oncology Trials
The field of oncology has undergone a major transformation over the last few decades. One of the most significant changes has been how early phase oncology trials are conducted. In the past, these trials were often designed as large, randomized Phase III trials. However, recent years have shifted towards smaller, more targeted Phase I and II trials.
There are several reasons for this change:
- A greater understanding of the significance of molecular targets in cancer treatment. This has led to the development of more targeted therapies that are more likely to be effective in earlier stages of the disease.
- The costs of conducting large clinical trials have increased dramatically, making it difficult to justify their expense.
- The success rates of Phase III trials have decreased over time, while the success rates of smaller Phase I and II trials have remained relatively stable.
This shift towards smaller early phase oncology trials is likely to continue in the future. As our understanding of cancer improves, we can develop more targeted and effective treatments that we can test in smaller trials. This will ultimately lead to better outcomes for patients with cancer.
What is an Early Phase Oncology Trial?
An early phase oncology trial is a clinical study that tests the effectiveness of new cancer treatments in humans. These studies are essential for developing new treatments and improving the care of cancer patients. Early phase trials are typically small, with a limited number of participants. They are often the first step in testing a new treatment before it is given to a larger group of people in later phase trials.
Why are Early Phase Trials Evolving?
The development of targeted therapies and immunotherapies has led to a new era in cancer treatment. As a result, early phase oncology trials are evolving to keep up with these advancements.
Targeted therapies are designed to target specific molecules involved in the growth and spread of cancer cells. This allows for more precise and effective treatment with fewer side effects. On the other hand, immunotherapies work by harnessing the immune system’s power to attack cancer cells.
Both of these approaches show great promise in the fight against cancer. As a result, early phase oncology trials are evolving to test these new treatments.
- One major change is that trials are now testing combinations of different therapies. This is because targeted therapies and immunotherapies often work best when used together. Researchers can find the most effective treatments for each patient by testing combinations of therapies.
- Another change is that we conduct most clinical trials across multiple centres. This allows increased patient enrolment in trials, which is vital for finding effective treatments.
- Finally, trials are now using new technologies to collect data. This data is then used to improve the design of future trials.
How are Early Phase Oncology Trials Evolving?
The field of oncology is constantly evolving, and early phase oncology trials are no exception. These trials are essential for testing new treatments and therapies for cancer, and they have already undergone many changes in recent years.
The future of early phase oncology trials is looking very promising. The main goal of these trials is to find new and effective treatments for cancer and to do so in a way that is efficient and minimizes the risk to patients. Many new technologies and approaches are being developed that show great promise in helping to achieve these goals. Here are some of the ways we predict that early phase oncology trials will evolve:
1. More focus on precision medicine
One of the biggest trends in oncology right now is precision medicine, which involves tailoring treatments to a patient’s tumor. This approach is being increasingly used in early phase trials, as it can help to improve efficacy and safety.
2. Greater use of immunotherapy
Immunotherapy, which harnesses the immune system’s power to fight cancer, is another area that is seeing more attention in early phase trials. This is because immunotherapy has shown great promise in treating a variety of different cancers.
3. More use of biomarkers
Biomarkers are used more frequently in early-phase oncology trials to select patients who are most likely to respond to a particular treatment. It helps to improve the chances of success for these trials. Using biomarkers to select patients for clinical trials will help ensure that only those most likely to benefit from a particular treatment enrol in the trial. This can help improve the trial’s chances of success and reduce the number of patients exposed to potentially harmful treatments.
4. More patient-centric trial designs
A growing trend toward designing trials puts the patient at the centre of care. This concept is referred to as “personalized medicine” (or “individualized therapy”), and it involves tailoring treatment to a patient’s unique genetic makeup, tumour characteristics, and medical history.
5. More trial designs that involve biomarkers
Biomarker-guided trials are another emerging trend in early phase oncology research. Such trials are designed to determine whether certain treatments work better than others on particular types of tumours and cell lines containing specific genetic alterations.
6. Novel delivery methods for drugs
Another promising area of research is using novel delivery methods for cancer drugs. This includes using nanoparticles or other targeted delivery systems to target cancer cells without harming healthy cells. This approach can help improve treatments’ efficacy while minimizing side effects.
Many other exciting developments are taking place in the field of early phase oncology trials, and it is an exciting time to be involved in this field of research. We will likely see many more breakthroughs in the years to come, ultimately benefiting.
Selecting a CRO for an early phase oncology trial
The early phase of oncology trials is crucial in developing new cancer treatments. However, the success of a trial can hinge on the contract research organization selected to manage it. With so much at stake, how can sponsors choose the right CRO for their early phase oncology needs?
There are a few key factors to consider when selecting a CRO for an early phase oncology trial.
- Experience in running similar trials
- A good understanding of the complexities of oncology drug development
- The ability to provide comprehensive services from start to finish
- An in-house Early Phase Unit
- A network of sites and leading cancer centres
- Established relationships with investigators
- Access to state-of-the-art diagnostics
Biomapas Nordic AB Appoints Ola Jeppsson to CEO & Business Development Director
August 2021 Ola Jeppsson has taken on a leading role as Business Development Director. In addition to his new role, he was appointed as a Chief Executive Officer at Biomapas Nordic AB starting August 2021.Having a management and business development background in the...
7 Reasons To Include Eastern Europe In Your Clinical Trial Strategy
Choosing the right set of countries, sites and investigators for a clinical trial are critical success factors in any clinical development program. They can guarantee speedy patient recruitment and timely delivery of study results. It also ensures that you conduct...
Clinical Study Start-Up: Is there any Difference Between Western and Eastern Europe?
This article reviews Clinical Study Start-up Differences Between West & East Europe, timelines, and processes. Medicine is constantly evolving to invent effective ways to treat diseases. This progress is a never-ending process: the life science industry develops...
Running a Clinical Trial in Ukraine
Despite the fact that Ukraine is the largest country in Eastern Europe with a large population of treatment-naïve patients, well organized public health care sector and significant number of medical sites accredited for clinical trial conduction, country has utilized only 15% of its current potential for hosting clinical trials. During 2017, the European Medicine Agency (EMA) gave positive recommendations on 94 new drug applications and 49 of them were tested in clinical trials in Ukraine. During the same year, the US FDA approved 151 new drugs, and 28 of them were also studied in Ukraine.
What You Need to Know about Running a Clinical Trial in Russia?
Russia is a very perspective country for international clinical trial conduction. The first international clinical trial was set up in Russia about 20 years ago only, and from than country kept a great potential for market development. In 2018 health authorities (HAs) approved 653 clinical trials (CT) in Russian Federation, less in overall numbers compared to the same indicator from 2016 – 898 approved CTs. However, this decrease was observed across all types of clinical trials except for international multicentre clinical trials (IMCT).
The CIS Region: Excellent Potential for Patient Recruitment but is there any Risk to Quality?
The number of clinical trials worldwide is increasing more than 10% each year due to the new diseases, further research for better health products and development of new drugs. Though, for a successful clinical trial, there is a major challenge – patient recruitment, which is essential and the most challenging factor due to the increasing number of new clinical trials. In order to achieve the required patient recruitment, sponsors are looking for different solutions.
Running a clinical trial in the Baltic states
In the past five years, an average of 175 clinical trials are being initiated in the Baltic states each year. An average of 64,8% of the population in the Baltic states are in the age from 15 to 65 years old, the main target audience for clinical trials. Furthermore, a large pool of treatment-naïve subjects is available compared to other EU countries or the US. Patients with special therapeutic diseases are transferred to the main central hospitals.
Remaining Vigilant and Compliant after Brexit: What’s next? (Latest Updates)
On 29th March 2017 UK submitted the notification of its intention to withdraw from the EU. This means that UK will become a ‘third country’ from 30th March’19. Even though leaving the EU with a deal remains the Government’s top priority, UK drug agency is publishing a series of guidance documents for industry and other stakeholders covering the proposed arrangements for the regulation of medicines, medical devices and clinical trials, if UK leaves EU with no deal.
Tuberculosis Medicines Clinical Development in Eastern Europe and CIS
World Tuberculosis Day is commemorated every year on 24th March to raise awareness of tuberculosis, which is still causing death of nearly 1.5 million people each year, mostly in developing countries. It marks the day in 1882, when Dr. Robert Koch announced that he had discovered the cause of tuberculosis, the TB bacillus. In comparison to other infectious diseases caused by a single infectious agent, tuberculosis is the second biggest killer worldwide.
AICROS Annual Meeting: insights and future perspectives
The Association of International Clinical Research Organizations (AICROS) is a network of small to mid-size CROs, which provide clinical research services to the pharmaceutical, biotech and medtech industries. Biomapas joined AICROS in 2014 and since then has been an active member of the association. On the 20-22 February, Biomapas’ CEO Audrius Sveikata participated in the AICROS Annual meeting, which took place in Tel Aviv, Israel. Audrius shared his insights about the meeting and the future perspectives of the association.
