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About Our Company
Dr. Andrew Bottomley
Leading Expert in Patient-Reported Outcomes & Quality of Life Research.
Welcome to Bottomley Consulting Group (BCG), where we provide high-level, concierge consultancy services in the design and implementation of clinical trials focused on Patient-Reported Outcomes (PROs) and Health-Related Quality of Life (HRQOL).
With over 27 years of international experience, our founder Dr. Andrew Bottomley is a recognized thought leader in clinical outcomes research and oncology trial design. He has led the development and validation of dozens of QOL measures and has authored more than 265 peer-reviewed publications. When you work with us, you engage directly with Dr. Bottomley—ensuring you receive personalized, expert-driven insight on every project.
What We Do
We support biopharma, CROs, and academic partners by providing:
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Strategic design of clinical trials with integrated PRO/QOL endpoints
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Protocol writing and review aligned with SPIRIT-PRO and CONSORT-PRO guidelines
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Data analysis and interpretation of QOL outcomes, including regulatory-ready reporting
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Selection and validation of PRO measures, including tool recommendations tailored to therapeutic area and trial objectives
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Publication development and scientific communication
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Literature reviews, HTA alignment, and market access strategy
Why Choose Us
At Bottomley Consulting Group, we understand that QOL endpoints are no longer “nice to have”—they’re essential for demonstrating patient value, informing regulatory and HTA decisions, and improving trial impact.
Dr. Bottomley brings unmatched experience from his collaborations with regulatory agencies, global oncology groups, and top-tier pharmaceutical clients. Unlike many firms, we don’t offer off-the-shelf solutions. You won’t get recycled slide decks or junior consultants. You’ll get hands-on, senior-level support—every time.
Tailored, Not Template
Whether you’re developing a QOL strategy for your pivotal trial, responding to regulator feedback, or preparing for HTA submission, we offer:
✅ Direct expertise—No intermediaries
✅ Custom deliverables—Not generic templates
✅ Clear, evidence-based guidance—Built from decades of peer-reviewed research
Let’s Talk
Explore how Bottomley Consulting Group (BCG) can help you bring patient-centered endpoints to the forefront of your clinical program.
Contact us today or watch this short video to learn more about our services.
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, or “bait and switch” 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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