Editorial
Ricardo F. Allegri1
Fabian Roman2
Ernesto Barceló3
How to cite this article:
Allegri, R. F.; Roman, F. & Barcelo, E. (2024). Editorial. How to improve diversity and equity in clinical trials through telemedicine? Journal of Apllied Cognitive Neuroscience, 5(2), e6220. DOI https://doi.org/10.17981/JACN.5.2.2024.6220
Dementia research is diverse, but sparse or non-existent in some regions of the world. According to Clinicaltrials.gov, 78.8% of all clinical trials were developed in Europe (51.4%) and the United States (27.4%). Only 14% were carried in Asia, 4.5% in Latin America, and 2% in Africa (Llibre et al. 2023). There are large cultural, educational, ethnic, and socioeconomic differences between the world´s populations in different regions. Results obtained in one location are often not generalisable to all regions. Clinical research need to increase diversity and improve inclusion (Langbaum et al. 2022).
New online technologies, accelerated by the COVID-19 pandemic, have led to the massive development of tele-education, telemedicine and teleneuropsychology with cognitive assessments (Crivelli et al., 2022) and remote rehabilitation (Canyazo et al., 2023). Clinical trials cannot and should not be dissociated from these changes, which are essential to access and allow the participation of patients living in areas further away from large urban centers or central countries, and even the same macropolis, the advantage of avoiding hours of transport and waiting.
This leads to the possibility of developing clinical trials outside the usual canon, with greater equity of access, the possibility of broadening the diversity of participants, as well as reducing their operational costs.
Howard et al. (2024) of the Alzheimer’s Association Clinical Trials Group published a consensus on the potential validity of remote clinical trials and generated 40 recommendations for their development from phase 2b to phase 4.
Some of the comments worth highlighting in the article (Howard et al. (2024) were:
1. Eligibility of a centre can be adequately completed remotely.
2. Data collection can be fully online.
3. Patient retention and follow-up can be easily done remotely.
4. Medications dispensing:
a. Initial face-to-face dispensing is preferred to better explain the mechanism of drug intake.
b. Tablet Trials may be dispensed remotely.
c. Trials involving intravenous infusions should only be dispensed and administered by professionals trained in the institution and may be continued at home after 2 to 3 administrations at the maximum dose.
d. In Trials involving subcutaneous medications may be remotely dispensed, but only after proper administration has been confirmed
5. Compliance
a. In phases 2b and 3, the blisters must be returned to the centre or, failing that, photos of them must be sent.
b. In phase 4, only the return of photos may be used.
6. Security
a. Reporting of adverse events
i. Phases 2B and 3: the investigator may give a verbal checklist.
ii. Phases 2B, 3 and 4: the participant may answer an online checklist but this data must be reviewed by the investigator in a timely manner
b. Reporting of serious adverse events
i. They may be reported using a checklist but must always require a telephone call or video conference.
ii. Access to local medical records must be available
iii. Must be followed up by the investigator
7. Assessment of cognitive decline and dementia
a. It must be measured by cognitive tests validated for the online method to be used.
b. The same modality must be repeated longitudinally.
c. In phases 2b: the presence of a possible change in diagnosis requires a video or face-to-face assessment, supplemented by a secondary source such as the medical record.
d. In phases 3 and 4: the presence of a possible change in diagnosis requires a video or face-to-face assessment, supplemented by a secondary source such as the medical record.
e. In phase 4: from a secondary source such as the medical record, provided it has been carried out by a qualified professional.
f. Outcome measures should be instrumented and validated online or by telephone.
Telemedicine has brought patients closer to professionals and reducing distance, time and cost of services. Its role and scope in clinical trials should be considered in order to achieve more equitable research in the near future, both by and for the type of population.
Canyazo CM, Keller G, Helou B, Arruabarrena M, Corvalán N, Carello A, Harris P, Feldman M, Fernández R, Calandri IL, Martin ME, Allegri RF, Crivelli L. (2023). Effectiveness of cognitive rehabilitation on mild cognitive impairment using teleneuropsychology. Dement Neuropsychol, 17, e20220079. doi: 10.1590/1980-5764-DN-2022-0079.
Crivelli L, Quiroz YT, Calandri IL, Martin ME, Velilla LM, Cusicanqui MI, Yglesias FC, Llibre-Rodríguez JJ, Armele M, Román F, Barceló E, Dechent C, Carello MA, Olavarría L, Yassuda MS, Custodio N, Dansilio S, Sosa AL, Acosta DM, Brucki SMD, Caramelli P, Slachevsky A, Nitrini R, Carrillo MC, Allegri RF. (2022). Working Group Recommendations for the Practice of Teleneuropsychology in Latin America. Arch Clin Neuropsychol, 37(3), 553-567. doi: 10.1093/arclin/acab080.
Howard L, Abdelnour C, Abner EL, Allegri RF, Dodge HH, Gauthier S, Hoyos CM, Jicha GA, Kehoe PG, Mummery CJ, Ogunniyi A, Scarmeas N, Chen X, Titiner JR, Weber CR; Peters R. (2024). Clinical Trial Methodology Working review group members; Decentralized clinical trials for medications to reduce the risk of dementia. Consensus report and guidance Alzheimers Dement, 20(7), 4625-4634. doi: 10.1002/alz.13891.
Langbaum et al. (2022). Recommendations to address key recruitment challenges of Alzheimer’s disease clinical trials Alzheimer’s Dement 2023, 19, 696-707
Llibre-Guerra JJ, et al. (2023). Diversity and Disparity Professional Interest Area Increasing Sustained Diversity in Clinical Trials Working Group. A call for clinical trial globalization in Alzheimer’s disease and related dementia. Alzheimers Dement, 19(7), 3210-3221.
1 Department of Cognitive Neurology, and Neuropsychiatry, Instituto Neurológico Fleni. Buenos Aires, Argentina http://orcid.org/0000-0001-7166-1234
2 Dirección general, Red Iberoamericana de Neurociencia Cognitiva. Buenos Aires, Argentina https://orcid.org/0000-0001-7741-3602
3 Departamento de Ciencias de la Salud, Universidad de la Costa. Barranquilla, Colombia https://orcid.org/0000-0001-5881-4654