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About Our Company
Welcome to our consultancy service, where we provide concierge services for designing clinical trials and studies where Patient Reported Outcomes (PRO) and quality of life (QOL) is the endpoint. Our founder, Dr. Andrew Bottomley, is an academic expert with over 25 years designing measures and cancer clinical trials. He will personally undertake all major tasks to provide you with a highly personalized and specialized service.
We offer a comprehensive range of services, including the design of trial protocols, analysis of quality of life data, and publications. We also provide assistance with reviewing literature and developing patient-reported outcome strategies for pharmacutical companies regarding their policy and use of quality of life and patient-reported outcomes in their trials.
At our consultancy, we recognize the significance of addressing quality of life as a crucial component of clinical trials. Dr. Bottomley has extensive experience working in colloboration with regulatory agencies and major pharmaceutical companies, providing top-level expert services that have helped clients achieve their goals.
Whether you require assistance with designing your clinical trials or developing patient-reported outcome strategies, we can provide you with customized solutions that cater to your unique needs. We promise what you won’t receive is “copy and paste” of standard slide sets, but expert, tailor made responses to meet your needs by one of the leading PRO experts in oncology. Please contact us to learn more about how we can assist you in achieving your goals or watch this short video of our services
Clinical added value of patient reported outcomes.
ESMO-MCBS (European Society for Medical Oncology – Magnitude of Clinical Benefit Scale) is a tool used to evaluate the clinical benefits of cancer treatments. It assesses the degree of clinical benefit that a given treatment provides compared to the standard of care or placebo, based on the available evidence.
For pharmaceutical companies developing cancer treatments, the ESMO-MCBS can be valuable in several ways:
- Regulatory Approval: ESMO-MCBS scores can be used as part of regulatory submissions to support the approval of new cancer treatments.
- Marketing: Companies can use high ESMO-MCBS scores to differentiate their cancer treatments from others on the market and to promote them to physicians and patients.
- Pricing: The ESMO-MCBS scores can also be used to support pricing decisions, as treatments with higher scores may command a premium price.
- Research and Development: The ESMO-MCBS scores can guide the prioritization of research and development efforts towards treatments with higher potential clinical benefits.
We revised this scale in 2023, where now QOL is a critical endpoint and can add major importance in the way a treatment is evaluated. Overall, the ESMO-MCBS can provide pharmaceutical companies with a standardized and objective method for evaluating the clinical benefits of cancer treatments, which can help inform decision-making throughout the drug development process. Contact me today to learn more about how my consultancy service can help you have success so new treatments have a good chance of success in being correctly evaluated.
Ethics
At our QOL and patient reported cancer consultancy company, we understand the importance of ethics when it comes to clinical research. Recent publications have highlighted shortfalls in ethics writing within studies involving QOL and patient reported outcomes in clinical trials and research studies. We recognize that such shortcomings can negatively impact endpoints, including hindering recruitment into QOL trials and any QOL sub-studies.
To address these concerns, we have assembled a small team of hand picked experts in ethics, including individuals with extensive experience in the EU and clinical trials. Furthermore, Dr Bottomley possess significant experience with EORTC quality of life tools and will ensure that this is clearly outlined in the patient information sheet and within the ethics section of protocols.
We are proficienct to review and write ethics consent documents that ensure QOL is appropriately presented, while also improving compliance among patients in cancer clinical trials. We are confident in our ability to provide a top-notch service that upholds ethical practices in clinical research.
To further support our clients in maintaining ethical standards in their research practices, we offer training and educational materials on ethics. Additionally, we can review all ethical your patient information sheets and forms before submission to national authorities, as a service.
We firmly believe that promoting ethical practices is crucial to ensuring the safety and wellbeing of patients. In summary, we offer a comprehensive approach to ethics in QOL and patient reported cancer studies, including expertise, training, and ethical form reviews. Trust us to assist you in achieving your research goals while maintaining the utmost ethical integrity.
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