Currents: Updates and Innovations

WHO Recommends New Name for Monkeypox

The World Health Organization (WHO) will begin using “mpox” as a synonym for monkeypox. Both names will be used simultaneously for 1 year while “monkeypox” is phased out.

When the outbreak of monkeypox expanded earlier this year, racist and stigmatizing language online, in other settings, and in some communities was observed and reported to WHO. In several meetings, public and private, a number of individuals and countries raised concerns and asked WHO to propose a way forward to change the name.

Assigning names to new and, very exceptionally, to existing diseases is the responsibility of WHO under the International Classification of Diseases (ICD) and the WHO Family of International Health Related Classifications through a consultative process which includes WHO Member States.

WHO, in accordance with the ICD update process, held consultations to gather views from a range of experts, as well as countries and the general public, who were invited to submit suggestions for new names. Based on these consultations, and further discussions with WHO’s Director-General Dr. Tedros Adhanom Ghebreyesus, WHO recommends the following:

• Adoption of the new synonym mpox in English for the disease.
• Mpox will become a preferred term, replacing monkeypox, after a transition period of 1 year. This serves to mitigate the concerns raised by experts about confusion caused by a name change in the midst of a global outbreak. It also gives time to complete the ICD update process and to update WHO publications.
• The synonym mpox will be included in the ICD-10 online in the coming days. It will be a part of the official 2023 release of ICD-11, which is the current global standard for health data, clinical documentation, and statistical aggregation.
• The term “monkeypox” will remain a searchable term in ICD, to match historic information.

Considerations for the recommendations included rationale, scientific appropriateness, extent of current usage, pronounceability, usability in different languages, absence of geographical or zoological references, and the ease of retrieval of historical scientific information.

Usually, the ICD updating process can take up to several years. In this case, the process was accelerated, though following the standard steps.

Various advisory bodies were heard during the consultation process, including experts from the medical and scientific and classification and statistics advisory committees which constituted of representatives from government authorities of 45 different countries.

The issue of the use of the new name in different languages was extensively discussed. The preferred term mpox can be used in other languages. If additional naming issues arise, these will be addressed via the same mechanism. Translations are usually discussed in formal collaboration with relevant government authorities and the related scientific societies.

WHO will adopt the term mpox in its communications, and encourages others to follow these recommendations, to minimize any ongoing negative impact of the current name and from adoption of the new name.

Almirall Joins Project Aimed at Giving Clinical Trial Data Back to Study Participants

Almirall is participating in FACILITATE (FrAmework for ClInicaL trIal participants’ daTA reutilization for a fully Transparent and Ethical ecosystem), a patient-driven Innovative Medicines Initiative (IMI) project that aims to create a framework for access and reutilization of clinical trial participant data.

FACILITATE’s main objective is to help return the clinical trial data to the study participants, ready for reuse in either further research or in health care practice, improving the current situation where clinical data are isolated in separate repositories and cannot be used outside the clinical trial.

Almirall’s main contribution focuses on providing expertise in privacy and pharmaceutical law issues, as well as in developing guidance, standards, and recommendations for the return of clinical trial data to patients. In addition, the company also contributes with its expertise in the specification of clinical trial use cases, stakeholder requirements, and the development of end-user tools.

FACILITATE is based on a patient-centered, data-driven technology platform with 27 partners from 17 EU and non-EU Member States. Participants include patient associations, hospitals, universities, innovative small and medium-sized enterprises, and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA), and with the Università degli Studi di Modena e Reggio Emilia as project coordinator.

The project, which was approved by the IMI Joint Undertaking (European Commission and EFPIA) in 2021, has been launched this year together with the FACILITATE website.

“The launch of FACILITATE further advances patient empowerment in clinical trials. At Almirall, we are excited to contribute to this patient-driven IMI project with our solid experience in clinical trials and our commitment to ethics and transparency. This project is fully aligned with our patient-centricity strategy aimed at improving their quality of life,” says Diego Herrera, Almirall’s FACILITATE Project Leader, in a news release.

FACILITATE is an IMI-JU project that builds on the collaborative efforts of many public and private partners and has the purpose to manage the return of individual clinical trial data in a trusted legal and ethical environment. Leveraging on a patient's needs, FACILITATE aspiration is to develop a prototype process which enables the return of clinical trial data during and after the clinical trial and allows for the secondary use of that data," adds Prof Johanna Blom, University of Modena-Reggio Emilia (UNIMORE) vice-coordinator of FACILITATE.

 FACILITATE project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No. 101034366. The JU gets support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

Castle’s DecisionDx-SCC Provides Clarity in Assessing Risk SCC Spread in Challenging Staging Situations

Castle Biosciences, Inc.’s DecisionDx-SCC test provides objective, independent and significant risk-stratification for cutaneous squamous cell carcinoma (cSCC) tumors with uncertainty in differentiation status.

The data were shared in an oral presentation given at the American Society of Dermatopathology (ASDP) 59th Annual Meeting by Sarah Estrada, MD, a dermatopathologist with Affiliated Dermatology in Scottsdale, AZ.

Overall, these data demonstrate how DecisionDx-SCC can significantly stratify the risk of metastasis in high-risk cSCC patients with an ambiguous tumor differentiation status. Additionally, the study suggests that incorporating the test’s results into clinical cSCC risk assessments could improve risk-stratification and enhance current patient management decisions to improve patient outcomes.

Subjective pathology variability in the histologic grading of cSCC tumors is an important clinical issue, particularly when comparing moderately differentiated tumors. Poor differentiation has been shown to be an independent risk factor associated with poor patient outcomes. However, there is a lack of consistency in differentiation assessment which can adversely impact the value of differentiation as a prognostic factor.

In fact, the two most widely used cSCC staging systems, American Joint Committee on Cancer Staging Manual Eighth Edition (AJCC8) and Brigham and Women’s Hospital (BWH), vary on their inclusion of poor differentiation as a risk factor for staging; BWH includes it, while AJCC8 does not.

“A single clinicopathologic risk factor, including a cSCC tumor’s differentiation status, can affect staging and thereby escalate or deescalate patient treatment plans,” commented Dr. Estrada. “Objective risk-stratification that is independent of clinicopathologic factors and staging, as provided by DecisionDx-SCC test results, can identify high-risk cSCC lesions and provide clarity in challenging staging situations.”

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