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Protocol writing

Our consultancy service provides expert support for all aspects of designing clinical trials where patient-reported outcomes are the primary or secondary endpoint. One critical area we specialize in is protocol writing related to the PRO endpoint, which is an essential step in the trial design process.

Dr. Andrew Bottomley, has extensive experience in writing protocols for clinical trials in oncology and related areas. We understand that writing a protocol requires careful consideration of the research question, study design, patient population, intervention, and outcome measures. We also recognize the importance of incorporating patient perspectives into the protocol to ensure that the study outcomes reflect their experiences and priorities.

Our approach to protocol writing is collaborative and tailored to meet the unique needs of each client. We work closely with our clients to ensure that the protocol aligns with their research goals and meets regulatory requirements and international standards that we have been involved in creating.  We provide guidance on selecting appropriate patient-reported outcome measures, developing study endpoints, and determining sample size and statistical analysis methods.

We strongly advocate the incorporation of SPIRIT -PRO guidelines into protocol development. These internationally recognized guidelines, formulated in collaboration with prominent global organizations, including Dr. Bottomley, offer a robust framework. Embracing these standards can significantly enhance the prospects of gaining approval from regulatory authorities, securing funding from agencies, obtaining favorable reviews from journal editors and peers, and garnering support from health technology assessment (HTA) bodies.

Overall, we understand the importance of a well-written protocol in ensuring the success of a clinical trial. With our expertise in protocol writing, we can help our clients design studies that incorporate patient-reported outcomes and produce meaningful results.

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