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Clinical Outcomes Solutions

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Clinical Outcomes Solutions

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A global research consulting group providing 360° support & services for clinical outcome research.

09/29/2026

Developing a new Clinical Outcome Assessment should not be the automatic answer when existing measures fall short.

Before developing a new COA, the first question is whether the concepts that matter to patients can be adequately captured by an existing instrument. That requires understanding the concepts most relevant to patients, evaluating available instruments, assessing their content validity and measurement properties, and identifying whether meaningful evidence gaps remain. If those gaps cannot reasonably be addressed through an existing measure, development of a new PRO, ClinRO, ObsRO, or PerfO may be warranted. But that decision has implications for timelines, validation requirements, study design, and regulatory strategy.

Clinical Outcomes Solutions helps sponsors evaluate existing COAs, identify evidence gaps, and develop fit-for-purpose measurement strategies grounded in patient experience, rigorous measurement science, and the intended context of use.

Considering whether an existing COA is sufficient, or whether a new measure may be needed? Connect with COS to discuss the evidence needed to support your measurement strategy.

09/24/2026

We're heading to ISOQOL's 33rd Annual Conference!

Members of the COS team will join the global quality-of-life research community to exchange perspectives on how patient-centered outcomes, clinical outcome assessments, and evolving regulatory expectations continue to shape clinical development.

Attending ISOQOL? Schedule a meeting with our team in Prague to discuss your COA strategy, evidence needs, and clinical outcomes research.

Learn More: [Enter Link]

09/16/2026

A clinical trial can demonstrate statistically significant improvement and still leave an important question unanswered: Was the change meaningful to patients?

Interpretation of change is central to understanding treatment benefit, particularly when Clinical Outcome Assessments contribute to endpoint strategy. Sponsors need to understand what constitutes meaningful within-patient change, whether proposed response categories reflect patients' experiences, and how those findings can inform responder definitions.

Quantitative analyses can provide critical evidence, while qualitative insights can add context to what observed changes mean to patients. This is why qualitative and quantitative approaches can provide complementary evidence for interpreting COA results.

COS integrates qualitative and quantitative measurement science to help sponsors establish and interpret meaningful change, supporting scientifically defensible and patient-centered interpretation of treatment benefit.

Planning how meaningful change will be evaluated in your clinical program? Connect with COS to discuss how an integrated evidence strategy can strengthen the interpretation of your COA endpoints.

08/20/2026

When does improvement in an objective cognitive test become meaningful to the patient?

The new publication, “Defining a Clinically Meaningful Within-Person Change Threshold for the Psychomotor Vigilance Test in Narcolepsy Type 1,” is the first to derive within-patient meaningful change thresholds for the Psychomotor Vigilance Test (PVT), a neuropsychologically derived performance outcome measure (PerfO).

The PVT is a computerized 10-minute assessment of sustained attention based on lapses in response to visual stimuli. It provides an objective complement to patient-reported information about cognitive difficulties, with prior research supporting PVT lapses as a sensitive and reliable indicator of attention impairment in narcolepsy.

Using anchor- and distribution-based methods aligned with FDA Patient-Focused Drug Development Draft Guidance 4, the study identified a −2-lapse PVT threshold (range: −1 to −4) as indicating change meaningful to patients. This provides an empirically grounded benchmark for interpreting improvement in visual attention.

“The integration of objective performance measures with patient-reported measures exemplifies a patient-focused approach to clinical outcome assessment methods, which can be applied to the assessment of neuropsychological and other PerfOs used in narcolepsy as well as in other indications.” — Helen Doll, Principal Scientific Advisor, Clinical Outcomes Solutions

Importantly, the implications extend beyond a single threshold or indication. The study demonstrates how objective performance and patient-reported evidence can be integrated to strengthen the interpretation of treatment benefit and broaden patient-focused approaches to cognitive PerfOs.

We’re proud to recognize COS contributors Shruti Dave, Marisa Brimmer, and Helen Doll for this important contribution to measurement science.

Read the publication to explore the methodology and its potential application to cognitive PerfOs beyond narcolepsy: https://ow.ly/GcKM50ZBYnm

07/29/2026

A COA score only matters if it can be interpreted.

As clinical development becomes more patient-centered, sponsors must show how treatment impacts symptoms, functioning, and quality of life in ways that are meaningful to patients and clear to regulators.

Quantitative science is central to that shift. Psychometric methods support endpoint strategy, instrument selection, trial design, and interpretation of treatment benefit.

At Clinical Outcomes Solutions, we help sponsors build COA strategies that are rigorous, patient-centered, and fit for purpose.

Is your measurement strategy designed for interpretation from the start?

07/21/2026

The most costly COA issues often begin before a trial ever starts.

When patient input is delayed until late-stage development, sponsors may realize too late that an endpoint does not fully reflect the symptoms, impacts, or treatment priorities that matter most to patients. By then, timelines are compressed, protocols are often locked, and the ability to refine the measurement strategy is limited.

Early qualitative research helps mitigate this risk by grounding development in patients' lived experiences. Through concept elicitation and cognitive debriefing, sponsors can ensure that what is being measured is relevant, understandable, and meaningful for the target population.

At Clinical Outcomes Solutions, our Qualitative Science team supports sponsors in translating patient insight into scientifically robust, regulator-ready COA strategies.

How early is your team bringing the patient voice into the endpoint strategy?

07/15/2026

Gamification is gaining traction in digital health. But will it hold up under regulatory scrutiny in clinical trials?

For sponsors, innovation is not just about what is possible—it is about what is acceptable.

As COAs move into more digital and decentralized environments, gamification is being explored to enhance engagement and reduce patient burden. But if it changes how patients interact with an instrument, it may also affect how outcomes are measured and interpreted—raising important questions about reliability, validity, and comparability.

A recent publication, “Practical applications of gamification in patient-centered outcomes research and digital health, and its acceptance in clinical trials,” takes a practical look at this challenge. It outlines how gamification can be integrated into COA strategies while maintaining alignment with regulatory expectations.

We’re proud to see contributions from COS’s Tenage McDowell, Research Scientist, and Dr. Tara Symonds, Principal Scientific Advisor, helping bring scientific clarity to an area that is rapidly evolving, but not yet fully defined.

What evidence would you need to feel confident implementing gamification in a regulated clinical trial?

Read Full Article Here: https://www.frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2026.1652217/full

07/08/2026

Today, we’re highlighting Rasika Bombatkar, MSc, Qualitative Science Researcher, who was recently invited to deliver a keynote address at the 79th World Health Assembly at the World Health Organization (WHO) Headquarters in Geneva.

Drawing on her experience as a lung cancer patient advocate and her work with patient communities globally, Rasika spoke on the role of lived experience in healthcare systems and the need for more meaningful patient engagement in health policy and decision-making.

Her keynote highlighted three challenges patients continue to face across health systems: stigma, navigation, and power imbalances in healthcare decision-making.

Rasika’s advocacy reflects a core belief at COS: patient voices must not only be heard, but meaningfully centered.

Please join us in recognizing Rasika for her leadership and continued commitment to patient-centered healthcare.

07/02/2026

The FDA’s patient-focused drug development expectations have elevated the importance of measurement quality.

To demonstrate treatment benefit from the patient perspective, COAs must be relevant, reliable, valid, and interpretable in the intended context of use.

For COA endpoints, sponsors need to demonstrate that the selected instrument can measure the concept of interest and that changes in scores are meaningful. FDA discussions often focus on whether the endpoint is well-defined, whether the measure is fit for purpose, and whether the analysis strategy supports a clear interpretation of benefit.

That makes quantitative science a strategic component of regulatory readiness. Psychometric validation, meaningful change estimation, endpoint planning, and sensitivity analyses all help sponsors build stronger COA evidence packages.

At Clinical Outcomes Solutions, our Quantitative Science team helps sponsors prepare evidence that supports clear communication of treatment benefits.

Is your COA analysis strategy built to answer the questions regulators are most likely to ask?

06/28/2026

This Pride Month, COS celebrates our LGBTQ+ colleagues and community members, and honors the identities, experiences, and perspectives that make our workplace stronger.

As a company dedicated to elevating the patient voice, we know that listening, inclusion, and respect are not abstract values — they are essential to meaningful science.

That same commitment guides the culture we continue to build at COS: one where people feel seen, supported, and empowered to contribute fully.

On International Pride Day, we celebrate visibility, belonging, and the importance of creating spaces where every voice matters.

Happy Pride from COS.

Address

1820 E. River Road
Tucson, AZ
85718

Opening Hours

Monday	8am - 5pm
Tuesday	8am - 5pm
Wednesday	8am - 5pm
Thursday	8am - 5pm
Friday	8am - 5pm

Telephone

+15203259510

Website

http://www.clinoutsolutions.com/

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