ScienHub

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.