Services- Analysis of clinical Trials

Bringing clarity, consistency, and clinical value to your QOL data

The analysis of Quality of Life (QOL) and other Clinical Outcome Assessments (COAs) remains one of the most underdeveloped—and often misunderstood—areas of clinical research. Inconsistent methodologies have frequently been cited in the literature as a key reason why QOL data is underutilized in regulatory and HTA decisions.

At Bottomley Consulting Group (BCG), we specialize in supporting QOL endpoint analysis, with deep experience in both strategic planning and practical execution. Whether reviewing your Statistical Analysis Plan (SAP) or leading data interpretation, we ensure your COA data is both scientifically robust and clinically meaningful.

Strategic and Scientific Support – We assist sponsors with:

🧾 Reviewing or co-developing SAPs and analysis frameworks

📊 Applying appropriate statistical methods for longitudinal QOL data

🔎 Assessing clinical relevance and meaningful change thresholds

🧠 Supporting interpretation and communication of patient-centered outcomes for regulatory, HTA, and publication audiences

Our approach combines quantitative techniques, qualitative insights, and patient-perspective alignment to ensure your findings meet the expectations of regulators, payers, journals, and patients.

Built on Proven Methodology
Our expertise is grounded in the work of Dr. Andrew Bottomley, a former co-Principal Investigator of the SISAQOL-IMI consortium—a global initiative to standardize the analysis and interpretation of QOL data in cancer clinical trials.

Through this and other major collaborations, BCG remains at the forefront of modern, harmonized approaches to QOL data analysis that support:

Cross-trial comparability

Clinical significance interpretation

Regulatory acceptability

Fit-for-Purpose Analysis for Your Program

Our clients include pharmaceutical sponsors, CROs, cooperative groups, and academic researchers who value:

✅ Methodological rigor

✅ Clear linkage to clinical outcomes

✅ Strategic insight into how QOL results influence access and approval

Whether you’re preparing an NDA, an HTA submission, or a high-impact journal article, we’ll help you translate your data into evidence that matters.

Let’s Improve How QOL Data Drives Decisions
If you’re looking for experienced support in analyzing and interpreting QOL data from your clinical trial, Bottomley Consulting Group is here to help.

📩 Contact Us to learn more about our analysis and strategy services.