Clinical Outcomes Solutions

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

When does improvement in an objective cognitive test become meaningful to the patient?The new publication, “Defining a C...
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Using anchor- and distribution-based methods aligned with FDA Patient-Focused Drug Development Draft Guidance 4, the study identified a −2-lapse PVT threshold (range: −1 to −4) as indicating change meaningful to patients.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

A COA score only matters if it can be interpreted.As clinical development becomes more patient-centered, sponsors must s...
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?

The most costly COA issues often begin before a trial ever starts. When patient input is delayed until late-stage develo...
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?


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

Today, we’re highlighting Rasika Bombatkar, MSc, Qualitative Science Researcher, who was recently invited to deliver a k...
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.

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

This Pride Month, COS celebrates our LGBTQ+ colleagues and community members, and honors the identities, experiences, an...
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.

Today, COS honors Juneteenth — a day of freedom, reflection, culture, and community.Juneteenth is a time to celebrate th...
06/19/2026

Today, COS honors Juneteenth — a day of freedom, reflection, culture, and community.

Juneteenth is a time to celebrate the richness of Black culture and the many ways Black communities have shaped our shared history through leadership, creativity, resilience, storytelling, and so much more.

At COS, our work is grounded in listening and elevating lived experience. Today, we’re reminded that every story matters and that honoring those stories helps build a better, more inclusive future.

Happy Juneteenth.

"How do we know whether our COA is relevant for our study?” is a common question that we get from our sponsors. By the t...
06/16/2026

"How do we know whether our COA is relevant for our study?” is a common question that we get from our sponsors.

By the time a COA is implemented in a trial, sponsors may still face critical questions. Will patients understand the instrument as intended? Are the response options and recall period appropriate? Does the measure capture concepts that are meaningful in real-world settings? And will the resulting data be interpretable and credible to regulators?

Prospective mixed-methods studies are designed to answer these questions before they become risks.

By integrating qualitative and quantitative approaches, these studies allow sponsors to evaluate how a COA performs in practice. Qualitative interviews can assess relevance, clarity, and alignment with lived experience, while quantitative data can evaluate feasibility, completion rates, score distribution, reliability, validity, and early responsiveness. Together, these insights help determine whether an instrument is truly fit for purpose.

This is also where regulatory expectations have become more specific. U.S. Food and Drug Administration's PFDD Guidance 3 emphasizes that fit-for-purpose COAs should measure what matters to patients and be supported by evidence on item relevance, response options, and recall period. PFDD Guidance 4 further emphasizes that COA-based endpoints and interpretation of change should be well-supported by evidence, including evidence relevant to meaningful within-patient change.

At Clinical Outcomes Solutions, our Qualitative and Prospective Studies teams design studies that simulate real-world COA use, assess patient burden, evaluate administration modes, and generate early evidence to support the measure's interpretability and its meaningfulness to patients.

In a landscape where endpoint strategy can shape trial success, evaluating COA feasibility and relevance early is not just helpful; it's essential.

A clinical trial can show statistical significance and still leave a critical question unanswered: did the COA score cha...
06/11/2026

A clinical trial can show statistical significance and still leave a critical question unanswered: did the COA score change matter to patients?

That distinction is central to COA science. Sponsors must show not only that a treatment effect exists, but that it reflects meaningful improvement in how patients feel, function, or live.

Meaningful change analysis helps connect score changes to real-world patient experience through statistical methods, patient input, and endpoint interpretation.

At Clinical Outcomes Solutions, our Quantitative Science team helps sponsors evaluate COA data to support endpoint interpretation, regulatory communication, and evidence-based decision-making.

As expectations for patient-centered evidence grow, how is your team distinguishing statistical change from meaningful change?

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

Alerts

Be the first to know and let us send you an email when Clinical Outcomes Solutions posts news and promotions. Your email address will not be used for any other purpose, and you can unsubscribe at any time.

Contact The Business

Send a message to Clinical Outcomes Solutions:

Shortcuts

Share

Category