A Novel MS Patient-Centered Assessment to Monitor Symptomatology

Recent findings from a National Multiple Sclerosis (MS) Study estimate that nearly 1 million people in the US are living with MS, a number that has more than doubled since it was last reported in 1975. We at VeraSci are committed to helping our clients drive therapies forward to help patients suffering with this debilitating disease. Senior Medical Scientist, Mark Skeen, MD, and Senior Director of Neurosciences, Heather Snyder, PhD are using their expertise and knowledge to enhance research identifying treatment options for this widespread disabling neurological condition.

In the past, Multiple Sclerosis clinical trial endpoints have focused primarily upon measures of disease activity rather than patient-reported outcomes. There is a growing desire, especially from regulatory bodies, to inform endpoints measuring disease activity with the patient’s perspective on treatment interventions. We know from a conjoint analysis conducted by Wilson, L., et al. (2014) that patients with Multiple Sclerosis are willing to accept significant therapeutic risk if they can reasonably expect improvement in their symptoms.

To address the need for a patient-centric account of symptomatology throughout the course of a clinical trial, a sponsor requested that VeraSci develop an iPad-based assessment to monitor patients’ perspective on how much emotional or psychological distress their symptoms cause them. VeraSci answered this call with the Multiple Sclerosis Individual Outcome Assessment (MSIOA), a Pathway eCOA-based structured interview designed for this purpose in the VeraSci Innovation Lab. The MSIOA is being utilized in two large Multiple Sclerosis therapeutic trials and will be administered at visits throughout the trial. The frequency and severity of distress is captured for any MS-related symptom the patient has experienced within a two-week period and is tracked over time. The MSIOA focuses on identifying those symptoms that are most bothersome to the patient and tracks their frequency and severity of associated distress.

The development and use of the MSIOA highlights an exciting advancement towards increased sensitivity to, and measurement of, patient-centered symptom outcomes in MS research.

 

Wilson, L., Loucks, Al, Bui, C., et al. (2014). Patient centered decision making: use of conjoint analysis to determine risk-benefit trade-offs for preference sensitive treatment choices. J Neurol Sci, 344(1-2): 80-87.

VeraSci Celebrates International Women’s Day Through Women Leadership and Diversity

March 8th was International Women’s Day, a day that we at VeraSci celebrate the work of a group of remarkable women – women scientists. While Marie Curie usually dominates the women in science conversation, there are many other brilliant women scientists.

  • Not only did Mary-Claire King prove that humans and chimpanzees share 99% of the same genes, but she discovered the BRCA Gene proving that breast cancer can be inherited.
  • After taking x-ray photographs of crystallized DNA, molecular biologist, Rosalind Franklin, discovered that the structure of DNA is in the form of a double helix.
  • As the inventor of the Apgar Score, Virginia Apgar invented a way to quickly assess the health of a newborn child immediately after birth.

 

These are just a couple of the talented women who have paved the way for our scientists, not just our women scientists, but all of our scientists. VeraSci has always and will continue to seek out only the most qualified scientific talent available to help our clients and their patients, and it just so happens that 50% of our scientists are women.

 

Among these accomplished women, whose expertise and work encompasses Alzheimer’s Disease, MCI, Dementia, Schizophrenia, Multiple Sclerosis, Parkinson’s Disease, Anxiety, Depression and more, are:

 

Kathleen Anne Welsh-Bohmer, PhD, AbPP-cn, VP Neurodegenerative Disorders

Alexandra Atkins, PhD, VP Scientific Development

Anzalee Khan, PhD, Senior Director, Data Science

Heather Snyder, Phd, Senior Director, Neurosciences

 

At VeraSci, we are committed to excellence in our field. The kind of excellence that comes when we embrace all perspectives and defer to the knowledge and expertise of our workforce, no matter their gender. To us, this means doing our part and setting a positive example by highlighting our experienced and talented scientists not only on International Women’s Day, but each and every day of the year.

 

Learn more about the women and men who make VeraSci what it is here.

DA4S West Coast Wrap Up

VeraSci attended the 6th Annual Diversity Alliance for Science West Coast Conference, February 20th-21st in Laguna Beach, California.

VeraSci is honored to participate in one of the leading organizations in the life science and healthcare industries which promotes the economic growth of small and/or diverse businesses and improves the quality of patient care by fostering intimate relationships between those businesses, and corporations, academic, and governmental agencies.

This conference included many meaningful takeaways and presentations. Quita Highsmith, Genentech- Head of Alliance and Advocacy Relations, Co-Lead for Advancing Inclusive Research, presented on the importance of “Advancing Inclusive Research.” This presentation stressed the importance of minority groups participating in clinical trials and DNA tests (23andMe, Ancestry, etc.) to collect DNA databases to better diagnose. Gregory Barnes, Amgen- Exec Director and Chief Information Security Officer, presented on “Cybersecurity.” This presentation emphasized the importance of cybersecurity, increased threats to our data, and the need for multi-factor identification and DMARC. Finally, a panel of former drug and alcohol addicts, joined Tommy Begres, Director Clinical Affairs- Adapt Pharma- maker of Narcan, and Anthony Perez, Regional Healthcare Director, Walgreens, to discuss “The Opioid Crisis- Impact to Innovation.” This discussion focused on the opioid epidemic and what needs to be done to change this moving forward.

We can’t wait to see what next year brings!

 

 

VeraSci Demonstrates the Sensitivity of a Tablet-Based Assessment of Visuospatial Working Memory

Clinical drug trials in preclinical AD populations require novel approaches to participant identification, screening, and enrollment. Execution of these trials requires rapid development of cognitive screening instruments that are straightforward, sensitive to disease-specific pathology, and allow for the interpretation of findings over time relative to demographically age-matched normative samples.

Based on an established body of literature linking declines in hippocampal-dependent learning with the earliest stages of AD pathology, VeraSci has worked in conjunction with leading academics to develop a novel assessment of visuospatial working memory (VSWM).

In a recent validation study enrolling 175 healthy young adults (<55 years), 320 healthy older adults (≥55 years), and 70 individuals with subjective cognitive decline, statistically significant differences were demonstrated among the three groups for the visuospatial working memory total score, as well as the Sequential and Random subscores (p<.001 for all). Bonferroni-corrected post hoc tests showed a significant difference between the young adult group, the older adult group, and the group with subjective cognitive decline, with the older adult group performing significantly worse than the young adult group and the subjective cognitive decline group performing significantly worse than the older adult group on three measures (p≤0.001 for all comparisons).

These findings suggest that this tablet-based visuospatial working memory instrument may be sensitive to the earliest stages of cognitive impairment. The specificity of observed declines in hippocampal-dependent tasks such as this offer a link to underlying Alzheimer’s disease pathology not provided by more global cognitive screening instruments.

The validation study of the visuospatial working memory test was conducted in the VeraSci Innovation Lab, located in the company headquarters in Durham, NC.  The ongoing mission of the Innovation Lab is to produce scientifically-valid, innovative methods for cognitive, functional and clinical assessment in clinical trials across multiple therapeutic areas.

This data was initially presented at the 11th Annual Meeting on CLINICAL TRIALS ON ALZHEIMER’S DISEASE (CTAD).

An encore presentation containing additional psychometric data will be provided at the 15th Annual Meeting of the International Society for CNS Clinical Trials and Methodology, Washington D.C., 19-21 February 2019

VeraSci Demonstrates Sensitivity of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) in Subjective Cognitive Decline

Clinical trials in mild to moderate Alzheimer’s Disease (AD) rely on informant reports to characterize study participants’ performance on basic and instrumental activities of daily living.  As clinical trials move earlier in the AD continuum, however, these informant-based methods become very problematic. Unlike participants with mild-moderate disease, participants in primary and secondary AD prevention trials are generally healthy, often cognitively normal and largely independent. Thus, these informant-based assessment methods lack sensitivity to the subtle declines in instrumental activities of daily living in this patient population. Also, the inclusion of an informant in study designs is unnecessary, burdensome and may compromise enrollment.

The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) is a direct performance-based assessment of IADL functioning that uses a computer or tablet interface and is appropriate for multiple populations. Unlike informant-based measures, the VRFCAT is completed by the study participant directly; an informant is not required.

In order to evaluate the sensitivity of the VRFCAT to the earliest declines in self-reported cognitive function, our team at VeraSci partnered with academic colleagues to recruit and evaluate 245 healthy young adults (age 20-54) and 308 healthy older adults (age 55-97). Older adults were screened for subjective cognitive decline using the Cognitive Functional Instrument (CFI, also referred to as the ADCS Mail-In Cognitive Function Screening Instrument (MCFSI). The questionnaire was designed to assess recent changes in cognition and functional activities that are commonly affected in the development of MCI. Furthermore, increased CFI scores have been associated with amyloid burden in healthy older adults, suggesting that this self-reported measurement serves as a useful screening instrument for preclinical AD. Of the 308 older adults assessed, 61 met the criteria for Subjective Cognitive Decline based on CFI scores greater than or equal to 4.

Our results demonstrated that the VRFCAT is sensitive to the deficits of in older adults with subjective cognitive decline, as they performed significantly worse than age-matched normative controls on all VRFCAT endpoints. Both groups performed significantly worse than healthy younger adults (age 20-54). Participants with subjective cognitive decline also performed significantly worse than controls on cognition as measured by the Montreal Cognitive Assessment (MoCA) and Brief Assessment of Cognition (BAC) verbal memory. All VRFCAT summary measures had correlations greater than r=0.5 with MoCA performance and assessments of Verbal Memory (p<0.01 for all), suggesting consistency between VRFCAT performance and key cognitive indicators of decline in MCI and AD.

 

Full results are reported in the current issue of the Journal of Prevention of Alzheimer’s Disease.

A.S. Atkins, A. Khan, D. Ulshen, A. Vaughan, D. Balentin, H. Dickerson, L.E. Liharska, B. Plassman, K. Welsh-Bohmer, R. S.E. Keefe; J Prev Alz Dis 2018;5(4):216-224

http://www.jpreventionalzheimer.com/current-issue.html

Holiday Language Blog Series – Part Three, Cultural Adaptation

Welcome to the third and final installment of our three-part blog series highlighting the importance of choosing the right language services partner.

Cultural Adaptation and Localization

Cultural adaptation and localization of clinical trial translations can be pivotal components to the success of a clinical trial. Localization and cultural adaptation go beyond textual translation and modify content for regional and/or local consumption. Localization modifies content and elements of a trial to appeal to patient’s cultural preferences in their own local language.

Cultural adaptation and localization services are just as important as translation services to accurately represent the implementation and outcomes of a clinical trial. Cultural adaptation can improve the quality of formally translated instruments by ensuring tasks, stimuli, instructions and, scoring are appropriate for populations of interest. Detailed attention to these issues is likely to enhance any real signal in a clinical trial, where the translated instrument serves as an endpoint.

The notion of Santa Claus is not a uniquely American tradition. In fact, many countries and cultures around the world celebrate the tradition of Santa Claus although symbolism, languages and, customs differ greatly.

 

 

Using VeraSci’s methods for cultural adaptation, errors can be identified and corrected prior to use in clinical trials, yielding gains in the reliability and validity of translated instruments and avoiding costly delays. Our linguistic experts bring not only translation skills and cultural awareness to each project, but clinical trials experience as well, ensuring that the information provided does what it should do: enable trial participant understanding.

Accurate translation, interpretation, and cultural adaptation are vital to a successful global clinical trial. By working together with sponsors, regulatory committees and other suppliers of research-related services, VeraSci can cut costs, help you to meet critical trial deadlines, and ensure successful international clinical trials.

5 Benefits of Using VeraSci for Global Language Services

  • Quality: KPI of 99% first-time accuracy for all translations done by humans. Our unique workflow includes quality assurance oversight by a team of PhD-level scientists as well as in-house software development and information technology teams, ensuring that the complexities of medical and technical terminologies are correctly translated.
  • Clinical Trial Expertise: Our linguists are often specialists in their field and are considered subject matter experts. They must pass a stringent nationally and internationally recognized certification process and are supported by a team of PhDs and clinical professionals to guarantee scientifically accurate translations at all times. VeraSci has extensive experience in executing large multi-year projects around the globe and is dedicated to ensuring the highest level of language services delivered at the pace to support global clinical trials.
  • Customer Satisfaction: At VeraSci, we go beyond the industry standard to provide a higher level of translation accuracy and agility by delivering customer-focused solutions and processes.
  • On-Time Delivery: Our 100% on-time delivery metric illustrates our commitment to meeting deadlines. Guaranteed quicker turnaround times due to in-house linguistic assets and centralized project management operations
  • Competitive Pricing: VeraSci’s long-term relationships with our expert team of linguists allows us to obtain lower cost, giving us the flexibility to meet client requirements and customize project approach to meet budget requirements.

 

Click here to read Holiday Language Blog Series – Part One, Translation

Click here to read Holiday Language Blog Series – Part Two, Interpretation