Cultural Adaptation is Not an Option: International Research Benefits from Localization


Scientific research has become an increasingly globalized effort. As more countries prioritize their research funding, international clinical studies have become the norm. Localization of study tools, cultural awareness, and accurate translations have become crucial to the success of these global studies.

GLOBALIZATION REQUIRES LOCALIZATION

These days it’s common for a study to have sites in North America, Europe, and Asia all at once. When operating on a global scale, being able to adapt to the different cultural norms of the patients and healthcare providers can greatly reduce misinterpretations which could lead to invalid data. Additionally, many countries have laws protecting the rights and privacy of research subjects making it imperative that the subject can clearly understand the study when they consent to participate.

CULTURALLY RELATABLE SYMBOLS

Sometimes misunderstanding stems not from the words used, but from symbols that miss the mark. This disconnect is commonly addressed by the film industry. When Disney’s Pixar localized the animated film “Inside Out” for Japan, they swapped broccoli for green peppers in the scene where young Riley pouts about eating her veggies to better reflect the tastes of Japanese children. VeraSci addresses this disconnect in clinical trials. All translations of VeraSci’s Virtual Reality Functional Capacity Assessment Tool (VRFCAT) feature buses adapted to their locale. Each version localizes the appearance of the bus depending on where the assessment is being administered. US patients would board a single level bus, whereas, in the UK patients would board a double decker bus.

LACK OF CULTURAL ADAPTATION LEADS TO BAD DATA

Medical or technical language may prove challenging for the average translator to interpret and localize, and in some cases, it is valuable to use linguists who also have a clinical background. If the healthcare professionals who work with the patients receive badly translated materials not adapted to their locale, it may lead to the patient failing to follow instructions, discrepancies in prescriptions and study management between sites, and a lower probability of the proper treatment of potential side effects of the trial. All of which could result in inaccurate, unusable data and increased risk to patient health.

International research requires a sensitivity to the differences between cultures. Ensuring that efforts are made to adapt and meet the needs of participants around the world will help to protect both the safety of patients and the quality of data from the study.

Translating Traditions: Holidays Around the World

Translation alone is often not enough to ensure an accurate message; cultural differences can make it easy to misunderstand the intended meaning of a text. For this reason, VeraSci insists that cultural adaptation and localization are not an option when it comes to clinical trials. In honor of the upcoming holiday season, here are a few examples of cultural and location-based differences in traditions that a skilled linguist would be best suited to navigate.

Both Culture and Location Matter

Cultural adaptation and localization make translations both accurate and relevant to the reader. Imagine a French family sends out Christmas cards wishing everyone a happy holiday and encouraging them to keep warm. Their French acquaintances will appreciate the sentiment, but their friends in Australia will laugh. Being in the southern hemisphere, Christmas comes during summertime in Australia. Many people celebrate by going to the beach! Ideally, the message would be modified to encourage the Aussies to stay cool. This type of adaptation applies to clinical trials too; in fact, it can improve the quality of formally translated instruments by ensuring tasks, stimuli, instructions, and scoring are appropriate for populations of interest.

While many cultural traditions share similar origins, the traditions themselves can still diverge based on locale. For example, during Hanukkah, many Jewish families eat oil-based foods to commemorate the rededication of the temple and how a single jar of oil miraculously kept the Menorah lit for eight days. When this tradition is translated around the world, there are Jewish families in New York eating potato latkes while the Baghdadi Indian Jewish community in Kolkata (Calcutta) eat Malida made with flattened sweet rice. While both foods are fried in oil, they are still two different dishes.

Local Language Experts are Key

VeraSci’s certified translators and localization experts take the differences in culture and locale into account and modify their translations to best connect with the audience, smoothing the way for successful multi-lingual communication. These global language experts are typically native speakers of a target language and often hold advanced degrees in related fields. Many have clinical experience and are qualified to train raters and administer scales. The expertise of VeraSci’s linguists ensures that training and materials for international clinical trials are accurate and relevant to the staff and trial participants at each site regardless of location. This results in a reduction of misunderstandings that might cloud the clarity of the data being gathered.

Recognizing and adapting to cultural differences is imperative to the success of clinical trials with sites in multiple countries. Inaccurate translations can cause expensive delays, compromise data, or endanger patient health. VeraSci’s linguists modify translations and interpretations to reflect cultural and local norms.

From life-saving clinical trials to appreciating beautiful holiday traditions, cultural adaptation and localization should be used to promote understanding and improved communication worldwide.

A Novel MS Patient-Centered Assessment to Monitor Symptomatology

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