Tuesday 23 April 2024

How are Oncology Clinical Trials Advancing Cancer Medication?


 

Oncology clinical trials are indispensable in moving new cancer treatments from the laboratory to everyday patient care. There are numerous ways in which oncology trials advance innovation in cancer interventions. Continue reading as we highlight five ways clinical trials make an impact, including the effectiveness and efficiency of clinical research, successful patient engagement strategies, contribution to social value, pharmacovigilance to improve drug safety, and research collaborations to tackle oncology research challenges.

 

By Tamanna Bhardwaj

What are Oncology Clinical Trials

Clinical trials are vital in moving new cancer treatments from the lab through the different phases of clinical research and eventually to everyday patient care. Oncology clinical trials evaluate the safety and effectiveness of new interventions, including new medications, treatment combinations, surgery or radiation therapy approaches, or methods, e.g., gene therapy and precision oncology. Diverse patient populations from various cancer types and stages enroll in oncology trials, adhering to study protocols that document treatment outcomes and potential adverse effects (AEs).


The rising global cancer burden underlines the pivotal role of oncology clinical trials in discovering interventions to address the unmet medical needs of patients with cancer. In addition, findings from oncology clinical trials help steer cancer care toward more effective and personalized solutions.

Value of Oncology Clinical Trials

Clinical trials are essential as they contribute to the knowledge of advancing cancer medications, answer critical scientific questions, and suggest future research directions. Patients who participate in trials can access high-quality cancer care and treatment(s). In contrast to when clinical trials were seen as a last resort, patients today increasingly choose to participate in clinical trials to receive their first treatment.

Global Oncology Clinical Trial Market

Oncology CROs (Contract Research Organizations) play a fundamental role in developing cancer treatments. The extensive involvement of CROs can span from the initial stages of research to the complex and rigorous final stages of oncology clinical trials. To address the significant global disease burden of cancer, the pharmaceutical industry prioritizes and invests in oncology drug development efforts, which creates a valuable opportunity for sponsors to partner with oncology CROs. Consequently, the global oncology clinical trials market is thriving and has a promising outlook for leading oncology CROs that are newly emerging.


The global oncology clinical trial market reached US$12.98 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 5.30% to surpass US$21.65 billion by 2033. The U.S. oncology clinical trial market, valued at US$3.82 billion in 2023, is expected to grow at a CAGR of 5.50% to reach US$6.49 billion in 2033. By the study phase, the Phase I segment had the highest market share (32%) in 2023 and increased emphasis on biomarker-driven approaches, personalized medicine, and exploring innovative drug combinations.

How Oncology Clinical Trials Advance Cancer Medication

Oncology clinical research leading to therapeutic breakthroughs is vital in improving patient outcomes. Evidence indicates a dramatic rise in survival rates of patients receiving chemotherapy due to the discovery of more effective chemotherapy agents and radiotherapy due to significant advancements in technology. The expansion of oncology clinical trials is facilitated by a supportive regulatory environment with streamlined approval processes and reduced bureaucratic hurdles without compromising patient safety. In addition, growing R&D investment by pharmaceutical companies, biotech firms, and government entities helps drive oncology clinical trials.

1. Tech Advancements Impact Effectiveness & Efficiency of Oncology Trials

Technology advancements, including advanced diagnostic tools and data analysis, refine the precision of patient categorization and biomarker identification while enabling real-time monitoring of treatment responses. Examples include:


  • The application of artificial intelligence (AI) approaches to extract quantitative information from digital histopathology images for gynecological cancers and deep learning (DL) models show promising results in accurately diagnosing, classifying, and predicting treatment response and prognosis.

  • DL workflow predicts upper tract urothelial carcinoma (UTUC) protein-based subtypes associated with targetable alterations directly from routine histopathological H&E (hematoxylin and eosin) slides.

  • Use of AI to enhance global trial recruitment and operations, reach underrepresented populations, lower costs, and accelerate commercialization.

2. Patient-centric Trials & Successful Patient Engagement Strategies

With patient engagement becoming increasingly important in clinical trials, CROs are committed to utilizing the newest tech solutions to support the oncology community, sponsors, and physicians in making the right decisions and supporting a truly patient-centric approach to research. By prioritizing the patient experience, integrating patient-reported outcomes (PROs), and leveraging digital health technologies for remote monitoring, patient-centric trials create significant opportunities for innovation and efficiency:


  • The benefits of active patient involvement include improved recruitment strategies and patient experiences, potentially higher adherence to trial interventions, and more patient-centered trial outcomes.

  • PROs in oncology trials reflect the impact of cancer therapies from the patient's perspective. They can inform evaluations with evidence that cannot be obtained or deduced from reports or other biomedical measures. PROs can also support non-clinicians, e.g., administrators, policymakers, health technology assessors, and regulators when considering the cost-effectiveness of new interventions.

  • Impact on quality of life—Integrating clinical research into patient care can help patients with metastatic colorectal cancer benefit from treatments by first gaining a comprehensive understanding of patient experience and treatment outcomes through PROs.

3. Oncology Clinical Trials & Social Value

Oncology clinical trials and drug development contribute to social value.


  • An analysis of pediatric oncology trials revealed that a large proportion of Phase I trials informed further assessment and development of tested interventions.

  • Separately, a recent National Cancer Institute (NCI) analysis found that despite their focus on safety, Phase I trials of new cancer treatments have more potential for clinical benefit than commonly believed. Researchers attributed this to development of modern cancer drugs, such as targeted therapies, immunotherapies, and new combination therapies.

  • Beyond advancing oncology research, clinical trials enhance cancer awareness and patient education.

4. Pharmacovigilance to Improve Drug Safety

Researchers find that the development of pharmacovigilance (PV) and cancer research continues growing and that the complexity of cancer and its treatment makes PV critical in oncology. Acquiring relevant clinical safety data is essential to advance cancer medications. Examples include:

  • A study on drug safety in pediatric and young adult patients with hemato-oncological diseases demonstrated pro-active PV's importance in highlighting adverse drug reactions (ADRs) and improving drug safety.

  • An active PV model for oral anti-cancer drugs was found to play an essential role in the early detection and improved management of AEs.

  • The implementation of a post-marketing PV system, which first required the complex transition from clinical to the post-approval phase, provided a TFS Healthscience sponsor with complete oversight of its product’s safety profile and supported the U.S. and European Union (E.U.) approval of the sponsor’s very first product.

5. Collaborations to Tackle Research Challenges

Collaborations to advance cancer research take place at different levels, including collaborative efforts between industry and regulatory agencies to streamline processes and expedite the translation of promising interventions from research to clinical practice. Additionally, the NCI orchestrates programs and initiatives to support the research community's progress in cancer research.


Researchers also highlight the role of super collaborations with multiple international groups, each bringing their unique expertise to maximize knowledge synthesis and advance innovations in cancer treatment.


  • The Cancer Research UK (CRUK)-NCI Cancer Grand Challenges initiative works with the global research community and people affected by cancer to help identify the most complex problems affecting cancer research. The final list of challenges is posed to the research community.

  • The Cancer Moonshot initiative, which started in 2016, was renewed by President Biden in 2022. Its ambitious objective is to reduce the cancer death rate by a minimum of 50% over 25 years. In its first four years, the Cancer Moonshot initiative resulted in 49 clinical trials and more than 30 patent fillings.

Conclusion

Oncology clinical trials are indispensable in advancing new cancer medications from the lab to everyday patient care. The rising global cancer burden underlines the pivotal role of oncology clinical trials in continuously advancing cancer treatment to address the unmet medical needs of cancer patients. In addition, findings from oncology clinical trials help steer cancer care toward more effective and personalized solutions and recommend future research directions.

 

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Monday 22 April 2024

A New Era: The Latest Advancements in Radiation Oncology


 

Radiation oncology is a field marked by innovation and transformation. The latest advancements not only shape the landscape for cancer treatment but also the trajectory of patient outcomes. For dedicated professionals and resilient patients navigating the complex world of cancer, these developments offer not only hope but also detailed insights into the potential future of oncology. Here are the cutting-edge advancements in radiation oncology that are poised to make a significant impact on the fight against cancer.

 

By Addy Reeds 


Precision and Personalized Treatment Planning

Modern radiation therapy isn't just about irradiating cancer cells; it's about architectural precision. The advent of techniques like IMRT (intensity-modulated radiation therapy) and VMAT (Volumetric Modulated Arc Therapy) is altering the course of treatment planning by adapting doses with a previously unattainable level of precision. With these advancements, radiation can conform more closely to the shape of the targeted tumor. It means less collateral damage to surrounding healthy tissue and, subsequently, fewer side effects. The result is a treatment plan that is not just tailored to a type of cancer but to the individual patient's unique anatomy and physiology.

Proton Therapy

Arguably one of the most significant strides in radiation therapy, proton therapy is gaining traction for its ability to deliver high doses of radiation specifically to tumors, while minimizing damage to nearby healthy tissue. The reason? Proton beams are quite effective—more than traditional forms of radiation. They can stop at the tumor site, delivering the maximum dose precisely where needed. Furthermore, with advancements in proton therapy technology, it is becoming more accessible, paving the way for a new standard of care and raising the bar for radiation precision.

Image-Guided and Adaptive Radiation Therapy

Adaptation is the key to survivability, and this is no different when it comes to cancer treatment. In the case of adaptive radiation therapy, 4D imaging and daily tracking of anatomical changes allow clinicians to modify treatment plans on the fly. For a disease as dynamic as cancer, this is revolutionary. With image guidance, doctors can manage and, more importantly, anticipate changes in the size, shape, and location of tumors and surrounding organs. This predictive precision ensures that radiation targets disease at the right time and in the right place throughout the entirety of the patient's treatment.

Artificial Intelligence

With AI's pattern recognition and predictive analysis, it is no surprise that this technology is finding profound uses in the realm of radiation oncology. AI can now interpret images, guide treatment planning, and even help in the delivery process. The implications are vast, from automating time-consuming tasks to predicting patient outcomes based on a wide range of data. AI's influence is set to expedite the precision and personalization of radiation therapy, fostering a future where machines and clinicians work in tandem for the best possible patient care.

Brachytherapy and the Evolving Landscape of Internal Radiation

Brachytherapy, or internal radiation therapy, involves placing radioactive material directly within or near the targeted tumor. This proximity allows for a highly concentrated dose of radiation over a small area—ideal for quick actions against fast-growing tumors. With brachytherapy, the duration of treatment can be considerably reduced, as can the risk of damage to nearby healthy tissues. The latest innovations in this modality, which include high-dose-rate (HDR) brachytherapy and other techniques, signal a shift toward personalized, dose-escalated brachytherapy for an expanding range of cancer types.

 

The list of advancements in radiation oncology is not merely a catalog of progress; it is a signpost of hope and resilience. With each new technique and technology, we come closer to a future where cancer treatment is not just effective, but also minimally invasive and highly tolerable. For patients, these developments underscore a message of ongoing commitment from the medical community to expanding treatment options and improving quality of life. For professionals, it is a call to action, to continue learning and adapting in the face of innovation.

 

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Sunday 21 April 2024

Elevate Business Decisive Approach using IeB’s “NextGen Data Modernization” Model

 


Considering the sensitive nature of health information and stringent regulatory compliance requirements; it is daunting for healthcare organizations to precisely manage, evaluate, and extract critical insights from the vast amounts of data related to APIs, clinical trials, supply chain operations, and patient interactions.

 

By Nitin Jindal

 

Unlock the future of data-driven decision-making with Ingenious e-Brain. Our upcoming “NextGen Data Modernization” model is designed to transform your raw data into a strategic asset via a structured, step-by-step approach, driving innovation and competitive advantage.

Besides understanding their requirements, we support pharmaceutical companies in addressing different business-related queries around:

 

● Identification of promising compounds and targets

● Predicting the success of ongoing or planned clinical trials

● Drug repurposing

● Drug discovery

● Biomarker discovery

● Optimizing trial strategy

 

Revamp the Healthcare Sector with Advanced Data Analytics

Enterprises can employ our upcoming model to:

● Perform fast, objective assessments of asset and portfolio positioning within therapeutic and competitive landscapes

● Gain competitive intelligence and rapid insights into approved assets, those which are soon to be in the market, and which are most likely to enter

● Precisely forecast the outcomes of clinical developments, avoid unremunerative trials that will fail, and devote more resources to assets with a higher chance of obtaining regulatory approval.

● Infer the key insights that were hard to extract using basic tools & approaches.

 

Capabilities of the Model

1. Data Lake Implementation: Centralize your disparate data sources into a highly scalable and secure data lake, enabling advanced data management and analysis.

2. Text Analytics & NLP Solutions: Harness the power of text analytics and Natural Language Processing to unlock deep insights from unstructured data, enhancing customer understanding and operational efficiency.

3. Predictive Analytics: Empower your business with predictive models that forecast trends and behaviors, ensuring you stay ahead of market dynamics.

4. Business Intelligence:  Leverage our Business Intelligence solutions to transform data into actionable insights, driving smarter, data-driven decisions across your organization.

 

How are we supporting beyond data?

1. Expertise: Our team of experts brings deep industry knowledge and technical proficiency, ensuring your data strategy aligns with your business goals.

2. Innovation: We leverage the latest technologies and methodologies to deliver solutions that not only meet but exceed your expectations.

3. Customization: Our solutions are tailored to your unique business needs, ensuring you get the most out of your data.

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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