Oncology Drug Development and Clinical Trials
Oncology is the branch of medicine that deals with the prevention, diagnosis, and treatment of cancer. It is a rapidly evolving field that is constantly incorporating new research and innovations to improve the outcomes and quality of life of cancer patients.
Cancer continues to be a major cause of mortality worldwide, necessitating the ongoing need for clinical trials. However, clinical research in oncology presents several challenges. Multiple new agents are being tested for multiple new targets and managing this requires precise clinical expertise. Patient recruitment is another key strategic consideration, further complicated by an increase in the number of patients needed to demonstrate that a therapy provides a significant benefit for patients.
QPS ensures speedy patient recruitment through powerful associations with efficient study sites across Europe, USA, Asia, and Australia, innovative patient recruitment strategies, and close links with academia, Site Management Organizations (SMOs), and specialist networks. We maintain a large worldwide database of investigators to ensure high enrollment rates of patients selected according to strict eligibility criteria. In addition, we have the capability to recruit patients in countries with a high prevalence of cancers, especially lung and breast cancers.
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Contact QPS Today to Discuss your Next Clinical Trial!
Clinical trials significantly contribute to cancer treatment strategies. Through a dedicated framework of integrated oncology research clinics and investigators, QPS offers a full range of outsourcing solutions. Whether your candidate drug is a small molecule, biologic, immunotherapy, or other medication, QPS has the experience and resources to handle your drug development program and help get your product to market.
QPS has extensive expertise in the conduct of Phase I oncology clinical studies, having successfully conducted over 50 Phase I – II oncology studies across Asia, Europe, and the United States. Our experience includes a diverse spectrum of cancers, such as breast, head & neck, lung, and prostate cancer among others. Our staff provides high-quality studies, from initial planning through to execution, including Regulatory and Medical support as needed. We ensure smooth execution of your trial from start to finish.
QPS expedites patient enrollment by leveraging strong partnerships with effective study sites spanning Europe, the USA, Australia, and Asia. Our innovative patient recruitment methods and close collaborations with academia, Site Management Organizations (SMOs), and specialized networks facilitate swift recruitment. With a vast global database of investigators, we ensure enrollment of patients meeting stringent eligibility criteria. Moreover, we possess the capacity to recruit patients in regions with high incidences of cancers, particularly lung and breast cancers.
Clinical trials are essential for developing better treatments and improving the quality of life for cancer patients. Clinical trials can help doctors to learn things like:
- If a new treatment is safe and effective
- How a new treatment compares to the current standard of care
- What are the best ways to use a new treatment in combination with other therapies
- What are the possible side effects and risks of a new treatment
- How a new treatment affects different types of cancer and different groups of people
- Not all clinical trials are successful or lead to better outcomes
- Some clinical trials may have unknown or serious side effects
- Some clinical trials may require more time, tests, and visits than standard treatments
- Some clinical trials may not be covered by insurance or may have additional costs
- Breast cancer, with 2.9 million new cases
- Prostate cancer, with 1.8 million new cases
- Colorectal cancer, with 1.8 million new cases
- Lung cancer, with 1.7 million new cases
- Stomach cancer, with 1.1 million new cases
- Chemotherapy
- Hormone therapy
- Targeted therapy
- Immunotherapy
- Monoclonal antibodies
- Oncolytic viruses – one treatment approved
- CAR T-cell therapy – one treatment approved
- Cancer vaccines – one treatment approved
Gene Therapy and Cell Therapy in Oncology
Oligonucleotide-based therapy (antisense RNAs, aptamers, siRNAs, miRNAs, mRNAs, vectors) is receiving a great deal of attention and much of that attention is focused on finding treatments and potential cures for a range of different cancers. As a gene therapy CRO, QPS has supported cell and gene therapy product development since 2003 on 45+ ASO/siRNA/aptamers and 20+ mRNA/vectors programs and can use our hard-earned experience to help you navigate PK, immunogenicity, biodistribution, viral clearance, and ADME properties of these novel modalities in this rapidly expanding field. See the QPS Guide to Oligonucleotides.
As this is still a relatively new area, the preferred technology for the quantitation of oligonucleotide-based therapy in any biological matrix is not as well-defined as small organics or proteins and vaccines. QPS uses chromatographic, ligand binding, and QPCR methods for quantitation of oligonucleotide-based therapy. The choice of platform for detection and quantitation is based on the primary structure of the target, the number of monomeric units, the desired study design, and the comfort level of the sponsors with the various platforms.
Gene therapy is a way of treating or preventing disease by altering the genes inside an individual’s cells. Gene therapy is advancing cancer treatment by offering new options for patients with cancers that are resistant to conventional therapies, such as chemotherapy and radiation. Gene therapy can also reduce the side effects of other treatments, as it targets the cancer cells and spares the normal cells. See the QPS Ultimate Guide to Gene Therapy.
The development of new gene therapies for cancer is a complex and lengthy process, involving many stages of research and testing. There are 3 types of gene therapy being developed and tested for cancer treatment, that have also had a treatment approved in that category.
- CAR T-cell therapy
Which involves genetically modifying the patient’s own T cells, which are immune cells that can recognize and kill infected or abnormal cells. The modified T cells are engineered to express a receptor that can bind to a specific antigen on the cancer cells, and then infused back into the patient. The CAR T cells can then find and destroy the cancer cells. Six CAR T-cell therapies are currently FDA approved for the treatment of certain blood cancers1.
- Oncolytic virus therapy
Which uses viruses that can infect and kill cancer cells, while sparing normal cells. The viruses can also trigger an immune response against the cancer cells, or carry genes that can enhance the effectiveness of other treatments. An oncolytic virus therapy is approved for the treatment of advanced melanoma2.
- Cancer vaccines
Which are substances that can stimulate the immune system to recognize and attack cancer cells. They can either prevent cancer from developing, or treat existing cancer. Cancer vaccines can be made from cancer cells, antigens, or genetic material. The first therapeutic cancer vaccine to receive FDA approval is used in the treatment of certain prostate cancer patients3.
These are some of the types of gene therapy being used for cancer treatment, but there are also others, such as gene editing, epigenetic drugs, and nanomedicine.
The development of a new cancer drug is a complex and lengthy process that involves many stages of research and testing. It can take up to approximately 15 years or more to complete all the steps required for the FDA approval of a new drug1. However, this time span varies depending on the type of drug, the type of cancer, and the availability of resources and funding. Some drugs may be approved faster through special regulatory pathways, such as accelerated approval, breakthrough therapy designation, fast track designation, or priority review2. These pathways are designed to speed up the development and review of drugs that treat serious or life-threatening conditions and address unmet medical needs2. QPS is well positioned to provide Regulatory consulting support along the pathway from discovery, to development and approval.
QPS Now Offers Phase I Clinical Trial Services in Australia
Why would a Biotech conduct an early phase oncology study in Australia?
Conducting early phase oncology clinical trials in Australia can offer several advantages for pharmaceutical and biotech companies. The decision to choose a specific location for clinical trials is influenced by a combination of scientific, logistical, regulatory, and economic factors. Here are some reasons why companies might consider conducting early phase oncology clinical trials in Australia.
Quality Research Infrastructure:
Australia has a well-established and sophisticated research infrastructure, including renowned research institutions, academic hospitals, and clinical trial centers. These facilities often have experienced investigators and research staff, contributing to the quality of clinical trial conduct.
Skilled Investigative Teams:
The country has a pool of skilled and experienced clinical investigators and research professionals, providing the necessary expertise for the successful execution of early phase oncology trials.
Diverse Patient Population:
Australia has a diverse population, and including a range of ethnicities in clinical trials is essential to ensure the generalizability of study findings. This diversity may be advantageous for studying the efficacy and safety of oncology compounds across different genetic backgrounds
Efficient Regulatory Environment:
The Therapeutic Goods Administration (TGA) in Australia is known for its efficiency in reviewing and approving clinical trial applications. A streamlined regulatory process can expedite the initiation of clinical trials, reducing overall development timelines.
English-Speaking Population:
English is the primary language in Australia, facilitating effective communication between investigators, study participants, and sponsors. This can be advantageous for ensuring accurate data collection and interpretation.
Access to Key Opinion Leaders:
Australia is home to key opinion leaders in various medical and scientific fields, including oncology. Collaborating with these experts can enhance the credibility and scientific rigor of clinical trials.
Favorable Time Zone:
Australia's time zone is advantageous for global sponsors as it allows for real-time communication with international teams in regions such as the United States, Europe, and Asia.
Stable Political and Economic Environment:
Australia is known for its stable political and economic environment, which can contribute to a reliable and consistent regulatory framework for clinical trials.
Compliance with International Standards:
Australia adheres to international standards for clinical research, ensuring that trials conducted in the country meet the highest ethical and scientific standards.
Attractive Patient Recruitment and Retention:
The Australian population is generally receptive to clinical research participation, and the country's healthcare system can facilitate patient recruitment and retention.
While these factors highlight the potential advantages, it’s essential for sponsors to carefully evaluate their specific needs and objectives before choosing a location for early phase oncology clinical trials. Additionally, factors such as trial design, patient demographics, and regulatory requirements should be considered in the decision-making process.
Are there tax advantages to running clinical trials in Australia?
In addition to the benefits listed above, Australia offers several tax incentives and advantages for small biotech companies engaged in research and development (R&D), including drug research. The key tax incentives that may benefit small biotech companies conducting drug research in Australia include:
Research and Development (R&D) Tax Incentive:
- The Early Stage Investor Tax Incentive aims to encourage investment in qualifying early-stage innovation companies, which may include those involved in drug research. Eligible investors can receive tax incentives, such as a non-refundable carry-forward tax offset.
- Australia's R&D Tax Incentive is a program designed to encourage companies to undertake R&D activities. Eligible R&D activities may include drug discovery, preclinical and clinical research, and other activities related to pharmaceutical development.
- Eligible companies can claim a tax offset of up to 43.5% for eligible R&D expenditures if they are a refundable tax offset recipient, and up to 38.5% if they are a non-refundable tax offset recipient.
- Eligible companies engaged in R&D activities may also be eligible for a deduction for capital expenditure associated with those activities. This can include expenses related to constructing or acquiring buildings used for R&D purposes.
It’s important to note that tax regulations and incentives can change, and there are strict eligibility criteria, so it is advisable for companies to consult with tax professionals and legal advisors to ensure compliance and to take advantage of the most current incentives available. Additionally, companies should carefully review the eligibility criteria and documentation requirements associated with each incentive program to determine eligibility and maximize their benefits.
Links to Relevant Documents
- Prostate Cancer Clinical Trials
- CRISPR and the Continuing Quest for CAR-T Safety and Durability
- Is Stool Screening an Effective Tool for Preventing Colon Cancer?
- Skin Cancer Risk Concerningly High in Millennials & Gen Xers
- Cancer Trials Ask, What’s the Gut Got to Do With It?
- A Flexible Approach to Oncology Clinical Trials
- Attacking KRAS Proteins to Kill Cancer
- Lymphatic Delivery Offers Potential Perks for Kinase Inhibitors and Other Cancer Drugs
- Research Reveals a Fungi-Cancer Connection, with Potential Diagnostic Implications
- Precision Steering of CAR-T Therapies May Effectively Target More Tumor Types
