The Spanish Agency of Medicines and Medical Devices (AEMPS) has published the Guide for the Implementation of Decentralized Elements in Clinical Trials. This document, created by a multidisciplinary group coordinated by the AEMPS, addresses the increasing use of digital tools in clinical trials. It also complements the European 2022 guide, tackling aspects that were open to interpretation depending on the legislation of each member state. Both guides aim to provide clear recommendations for procedures carried out outside trial centers, ensuring data reliability and facilitating regulatory decision-making.

Decentralized clinical trials (DCTs) bring studies closer to patients through technologies such as telemedicine, virtual recruitment, electronic consent, and mobile nursing. This model helps involve people facing barriers such as distance, limited mobility, or lack of availability to travel.

During the COVID-19 pandemic, ScienHub successfully implemented home-based CTUs, adapting to patients’ needs. We continue to offer these solutions today to ensure the continuity of trials.

The document will be officially presented during the first quarter of 2025 in a discussion held at the AEMPS headquarters. The event will also be available for streaming.

As part of the IMMUNOCORE study, led by Dr. Bea Mothe and Aroa Nieto as Study Coordinator at ScienHub Research Support, a sponsor audit has been carried out with very positive results. The audit committee highlighted the quality of the work carried out and congratulated the team for its excellent management and execution of the study.

IMMUNOCORE’s study is a phase I/II study evaluating the safety, pharmacokinetics and antiviral activity of a new treatment for patients with chronic HIV infection. Tasks performed by team members include trial coordination, performing protocol procedures, data entry, and participant follow-up.

These positive assessments reflect the solidity and quality of the work of the ScienHub Research Support CTU team, made up of more than 20 professionals highly specialized in the implementation of clinical studies.

Last September, the 7th edition of the HIV Clinical Topics took place, an annual flagship event that brings together international experts to share the latest updates on HIV treatment. This meeting, focused on advances in antiretroviral therapies and new drugs in development, once again featured the notable participation of Dr. Rajesh Gandhi, professor of medicine at Harvard University and Director of HIV Clinical Services at Massachusetts General Hospital.

Dr. Gandhi shared his vision on the future of HIV treatments, highlighting the development of long-acting therapies as the current major trend: “I believe we are currently moving towards long-acting treatments, some of which can be taken orally on a weekly basis, while others may be administered every six months via injection,” Gandhi explained. He also emphasized the importance of developing therapies that address HIV-associated comorbidities, such as cardiovascular or metabolic diseases, and stressed the need to increase resources for HIV care research. “Our hope is that in the future, we will not only be able to manage this infection more effectively, but also work towards its eradication,” he concluded.

The CTU unit from ScienHub Research Support presented two posters at the XXI National Congress on AIDS and STIs, organized by SEISIDA. The congress focused on the theme “The Ages of HIV,” addressing various perspectives and challenges related to aging and the diversity of PLHIV.

• “Beyond Comorbidities: Over50 Cohort of PLHIV ≥ 50 Years Old Compared to a Control Group”: The results showed a higher prevalence of sleep disorders, chronic pain, sexual dysfunction, falls, depression, and loneliness in PLHIV compared to a control group. This underscores the need for specific approaches to geriatric care in PLHIV.
• “Redesigning HIV Care: A Significant Shift in the Profile of Individuals Newly Diagnosed with HIV”: The study concluded that there has been a significant increase in HIV diagnoses in primary care, suggesting a possible lack of information about the infection, a greater diversity of affected population groups, an increase in detection among women, and an increase in AIDS diagnoses. This highlights the need to adopt differentiated approaches for newly diagnosed individuals.

The participation of the CTU team in the congress underscores our commitment to research, advancing the understanding and improvement of care for people with HIV.

Today, May 20th, we commemorate a historic milestone in medicine: the first clinical trial conducted by Scottish doctor James Lind in 1747. This pioneering trial, which identified a lack of vitamin C as the cause of scurvy among sailors in the British Navy, laid the foundation for modern clinical research.

In the past six decades, clinical research has transformed our health and well-being and has contributed to achieving goals such as:

• Life expectancy in Europe has increased by almost 10 years.
• The mortality rate from HIV/AIDS has decreased by over 80% since the 1980s.
• The cancer mortality rate is 20% lower since the 1990s.

Source

In every clinical trial, the true heroes are the patients. Their active participation is key to the development of new therapies and treatments.

At ScienHub Research Support, we are committed to advancing research by providing comprehensive support in the management and implementation of clinical studies. From our CRO, we handle the management of clinical trials in all phases, including bureaucratic procedures, monitoring, and data management. From the CTU, we implement clinical trials strictly adhering to current regulations. We ensure the rights, safety, and well-being of the participants, as well as the quality of the data obtained.

Last April, ScienHub Education organized the 2nd workshop as a Center of Excellence in HIV and Aging with the aim of consolidating the recognition of the Fight Infections Foundation as specialists in HIV and Aging. In 2023, the foundation was accredited as a Center of Excellence in HIV and Aging by the Gilead Sciences program, highlighting its dedication to research, treatment, and care for people living with HIV.

The training, aimed at a small group of medical professionals from hospital centers in Catalonia, was designed with the goal of ensuring healthy aging and a better quality of life, addressing medical, social, psychosocial, functional, cognitive, and geriatric aspects.

Dr. Eugènia Negredo, head of the HIV section at the Germans Trias i Pujol University Hospital and researcher at the Fight against Infections Foundation, coordinated the workshop. The activity involved experts from her team and regular collaborators, thus reinforcing the foundation’s commitment to excellence in HIV and aging care.

The Hipra HH-4 study is a multicenter investigation aimed at evaluating the immunogenicity and safety of an RBD fusion vaccine (PHH-IV) against SARS-COV-2. This study specifically focused on adults with immunosuppressive conditions who were already vaccinated against COVID-19.

The CRO ScienHub Research Support coordinated the monitoring tasks among the three recruiting centers, and the CTU implemented the study at our center, collaborating closely and determinedly with the respective research teams.

Currently, ScienHub Research Support is offering assistance for two clinical trials underway in Spain under the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT). Sponsored by the University of Minnesota, European coordination is led by CHIP Copenhagen.

At the heart of this operation is the ScienHub Research Support’s CTU, responsible for orchestrating the study’s implementation at the Hospital Universitari Germans Trias i Pujol (HUGTiP). Their duties include executing visit procedures meticulously outlined in the protocol. Simultaneously, ScienHub Research Support’s CRO is diligently handling bureaucratic procedures and providing crucial management support. Furthermore, they are managing monitoring activities at various participating centers scattered throughout Spain.

Dr. Eugènia Negredo presents at #PostCROI some of the latest updates on aging and HIV discussed at #CROI2024, such as the REPRIEVE study, the first large-scale study to test a strategy aimed at preventing heart disease among HIV-positive individuals. The results of this study are likely to prompt changes in clinics, as they have shown that HIV-positive individuals taking Pitavastatin have a lower risk of developing cardiovascular issues. This represents crucial information that influences clinical practice and HIV management.

The SCHISTO-STOP study, aimed at implementing a screening strategy for schistosomiasis in immigrant populations at epidemiological risk, reveals promising preliminary results. Schistosomiasis is one of the most common helminthic infections worldwide, with serious health implications. In Catalonia, it is estimated that over 17,000 individuals are infected, yet only a small fraction have been diagnosed. Despite the existing treatment, Praziquantel, being safe and effective with cure rates exceeding 90%, many cases go unnoticed. Collaborative efforts between researchers and teams at ScienHub Research Support have enabled the study to be concluded on time, yielding promising results that could influence global strategies to enhance the quality of life for this vulnerable population group.