Expert support for integrating patient-centered outcomes into your trial design

At Bottomley Consulting Group (BCG), we provide specialized support for clinical trial protocols that include patient-reported outcomes (PROs) and other Clinical Outcome Assessments (COAs). Whether PROs are your primary or secondary endpoints, we help ensure they’re built into your protocol with scientific rigor and regulatory alignment.

Why It Matters

A clear and well-structured protocol is the foundation of any successful trial. When PROs or QOL endpoints are involved, precision in design, endpoint definition, and documentation becomes even more critical.

Poorly framed PRO sections can lead to:

Data that’s hard to interpret or support

Challenges during regulatory review

Missed opportunities for label inclusion or market access

What We Offer

With decades of experience in oncology and international standards development, Dr. Andrew Bottomley leads BCG’s protocol writing services. We provide hands-on guidance in:

Crafting protocol sections for PRO and symptom-based endpoints

Aligning with SPIRIT-PRO guidelines, regulatory best practices, and ICH standards

Defining fit-for-purpose COAs aligned with your study’s objectives and mechanisms of action

Advising on statistical considerations, sample size, and analysis strategy

Ensuring alignment with regulatory expectations and HTA requirements

A Standards-Driven Approach

BCG strongly advocates the use of SPIRIT-PRO, an internationally recognized extension of the SPIRIT guidelines, co-developed by global experts including Dr. Bottomley.

By embedding SPIRIT-PRO in your protocol, you strengthen your submission’s credibility and increase its acceptability with:

Regulatory agencies (e.g. FDA, EMA)

Funding bodies

Peer-reviewed journals

HTA and reimbursement decision-makers

Collaborative and Customizable

No two trials are the same. Our protocol support is tailored to your indication, trial phase, and global market strategy. We work closely with your medical writing, clinical, and regulatory teams to ensure PRO integration is efficient, feasible, and impactful.

Ready to Build a Stronger Protocol?

Whether you’re developing your first draft or refining your final version, Bottomley Consulting Group can help you design a protocol that puts patients at the center—while meeting the highest scientific and regulatory standards.

📩 Contact Us to learn more about protocol development support