06/15/2026 | AL1

https://al1.com.br/noticias/noticias/197862-pesquisa-clinica-acesso-a-tratamentos-e-potencial-do-brasil-colocam-setor-no-centro-do-debate-em-saude 

Clinical research has gained prominence in Brazil not only for its role in advancing science, but mainly for its direct impact on the lives of patients who find in clinical studies a real opportunity to access innovative treatments, often unavailable through traditional means.

In Brazil, this scenario takes on even greater relevance. The country possesses strategic characteristics that position it as one of the most promising markets for the development of clinical research in the world, such as ethnic diversity, a qualified medical staff, and research centers with recognized experience.

Clinical research plays a fundamental role not only in the development of new drugs, therapies, and vaccines, but also as a concrete alternative for patients facing serious or rare diseases who have exhausted the options available in the healthcare system.

“For many patients, clinical research represents the possibility of accessing treatments that are not yet commercially available. In many cases, it is a real chance to improve quality of life and even extend survival,” emphasizes Fernando de Rezende Francisco, executive director of the Brazilian Association of Representative Organizations of Clinical Research (ABRACRO).

In addition to the direct impact on the patient journey, the sector also drives the economy, generates qualified jobs, and strengthens the health innovation ecosystem. Even so, Brazil faces structural challenges that impact its competitiveness, such as regulatory deadlines and processes that could be more agile, especially in an increasingly dynamic international landscape.

06/15/2026 | Band.com

https://www.band.com.br/noticias/canal-livre/ultimas/avanco-em-pesquisa-clinica-aproxima-medicina-do-brasil-do-padrao-global-202606141702#google_vignette 

Oncologists discuss cultural differences in treatment between Brazil and the United States and highlight the expansion of scientific studies in the SUS (Brazilian Public Health System)

The quality of centers of excellence in private medicine in Brazil is on par with the main health services in the United States, but the clinical research landscape still establishes a significant distance between the two countries. Oncologist Antonio Buzardi, who worked for 13 years in American institutions, including Yale and Emerson universities, states in an interview with Canal Livre that the American territory remains light-years ahead in the development of new treatments, driven by investments that exceed global rates. Despite the disparity in the volume of resources, Brazil is showing structural progress in conducting international protocols.

The Instituto Vencer o Câncer (Cancer Victory Institute), co-founded by Buzardi and fellow oncologist Fernando Maluf, leads the expansion of the national scientific field with the creation of 20 research centers installed in hospitals of the Unified Health System (SUS) located in vulnerable regions of the country.

This initiative allows patients from locations such as Manaus to access clinical studies integrated with universities and hospitals of global prestige, such as Harvard, Memorial New York, and MD Anderson in Texas.

Cultural Differences and the Impact of Research on the SUS
The relationship between doctors and patients exposes striking cultural contrasts in daily hospital life. While the North American…

06/16/2026  |   WANG XIAOYU  |  China Daily.com

https://www.chinadaily.com.cn/a/202606/16/WS6a30a4f8a310986e2b460298.html 

Revised guideline ensures compliance with ethics, protection of participants

China has recently released a new edition of the Good Clinical Practice for Drugs — a guideline designed to ensure the ethical and scientific conduct of clinical studies, aiming to strengthen the nation's research ecosystem and support innovation in biotechnology.

The document, jointly issued by the National Medical Products Administration and three other government departments last week, is an update of the version that has been in effect since 2020. The new version is set to take effect on Sept 1.

According to the administration, key highlights of the guideline include the addition of provisions on data governance, as well as an emphasis on compliance with ethical principles, scientific rules, and relevant laws and regulations when applying new technologies and methods.

The guideline states that data governance should run throughout the entire clinical trial process, ensuring accurate reporting, validation, and interpretation of trial-related information.

Researchers are also required to establish procedures to guarantee the reliability, traceability, and security of electronic data, and to prevent data loss or tampering.

The guideline explicitly identifies the principal investigator as the responsible person at the site level and names the sponsor as the ultimate accountable party for all trial-related activities.

Sponsors are also required to consider the protection of participants' rights and safety as of fundamental importance when carrying out trials.

To further enhance the protection of participants, the guideline calls for strengthened ethics review…

06/15/2026  |  Gareth Macdonald  |  BioXconomy

https://www.bioxconomy.com/clinical-and-research/ema-prepares-for-major-clinical-trial-regulation-changes-under-eu-biotech-act-coming-this-year 

The agency will allocate resources to update systems before new rules take effect, aiming to speed assessments and cut administrative burden for sponsors.

The EU Biotech Act will result in “significant changes” to the Clinical Trial Regulation and Clinical Trials Information System, according to the European Medicines Agency (EMA).

The Amsterdam-based regulator made the comments this week, explaining its management board will allocate resources to prepare for these changes before the Biotech Act comes into full effect.

An EMA spokesperson told BioXconomy, “In December 2025, the European Commission proposed the Biotech Act. This aims to modernize the regulatory framework and, through more agile regulation, strengthen the EU’s competitiveness in research and development. 

“Building on what has already worked well under the Clinical Trials Regulation, the Biotech Act proposes amendments to support high-quality science, reduce administrative burden, and ultimately improve patients’ access to innovative treatments,” she added.

In addition to facilitating faster trial assessments, the Act will modify the CTR to give sponsors and CROs greater flexibility when it comes to adjusting ongoing studies, the spokesperson said. It will also prompt an update of the CTIS, the public database where sponsors log information about drug research.

Related:EMA proposes contract platform to aid sponsors, sites, and CROs

“The implementation of the Biotech Act will be supported by enhanced…

06/15/2026  |  Catherine Longworth  |  Clinical Trials Arena

https://www.clinicaltrialsarena.com/ai/clinical-trial-statistics-gets-an-ai-era-overhaul/?cf-view

For decades, statistical analysis has remained one of clinical research's most manual processes. As AI reshapes drug development, CROs and sponsors are asking whether biostatistics could be the next major efficiency breakthrough. 

or much of the pharmaceutical industry’s discussion around artificial intelligence (AI), attention has focused on drug discovery. Yet as sponsors race to shorten development timelines, another area of the clinical trial ecosystem is emerging as a candidate for technological disruption: biostatistics.

Despite decades of advances in data capture and trial management, many of the processes underpinning statistical analysis remain heavily reliant on manual programming, bespoke workflows, and labour-intensive quality control.

For an industry under increasing pressure to accelerate development timelines while maintaining regulatory compliance, the question is becoming harder to ignore: why are some of clinical research’s most critical workflows still operating much as they did decades ago?

That is the challenge that Veristat is attempting to address through InStat, an AI-enabled biostatistics platform designed to automate elements of statistical analysis and reporting while preserving the traceability required by regulators.

“We’ve been writing, checking and executing thousands of lines of study-specific code by hand for decades,” Kyle McBride, Vice President of AI and Innovation at Veristat tells Clinical Trials Arena. “At some point you have to ask: there’s got to be a better way to do this.”

A legacy process meets modern…