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The contribution of patient associations in clinical trials
Historically, patient organizations have had the primary purpose of supporting the communities they represented. Today, this remains a crucial function, but modes have changed, as has the role that associations and patients themselves take on in clinical research. The WHO Alma-Ata Declaration (September/1978) emphasized that [...]
The importance of the Data Monitoring Committee in the trials of today and tomorrow
Dr. Paola Antonini, Meditrial Scientific Director All clinical trials benefit from oversight, which is currently provided by regulatory authorities, Ethics Committees or Institutional Review Boards, and Data Monitoring Committees (Dmc), also sometimes referred to as Data Safety Monitoring Boards (Dsmb). The role and [...]
Early feasibility studies on devices: “doing it sooner” to avoid trial failure
Paola Antonini, Meditrial Scientific Director. It is estimated that more than 90% of clinical trials fail due to limited patient recruitment, investigator inefficiencies, insufficient understanding of local ethical and regulatory aspects, site and region selected for conducting the study. Conducting an Initial Feasibility [...]
SaMD, artificial intelligence and machine learning: regulators’ first steps
Dr.ssa Paola Antonini, Meditrial scientific director The International medical device regulators forum (Imdrf), describes Software as a Medical Device (SaMD) as software that can run on generic (non-medical) computing platforms. They can be used in conjunction with other medical devices or other hardware/software. [...]
Clinical trials, how biomarkers help research
Dr.ssa Paola Antonini, Meditrial scientific director In recent years, the field of biomarkers in research and clinical practice has shown remarkable progress. These tests can be used in the screening, diagnosis, characterization, and monitoring of diseases; as prognostic indicators; for the development of [...]
CYBERSECURITY FOR MEDICAL DEVICES: PROTECTING YOURSELF FROM RISKS WITH BLOCKCHAIN
Cyber attacks can cripple the operation of systems in any sector. However, in the case of health care, such paralysis can be a matter of life and death. Recently, medical device security has become a global concern and a focal point for regulators and [...]
CAREERS IN CLINICAL DEVELOPMENT: PHYSICIANS OF 2030
Health care is connected to every aspect of society. We rely on highly qualified physicians to keep us healthy by using their vast knowledge and progressively more advanced clinical tools and resources. But physicians around the world involved in developing new modes of care [...]
SOLVING THE DATA MANAGEMENT CHALLENGE IN DIGITAL CLINICAL TRIALS
When novel drugs or medical devices are evaluated in clinical trials, the data generated in this process is called clinical data. Improving the use of technology in clinical trials is now a prime opportunity for the life sciences industry. Digital trial processes enable us [...]
CLINICAL TRIAL DESIGN: THE REVOLUTION OF NEW STATISTICAL PRINCIPLES
Edited by Dr. Monica Tocchi, Meditrial medical director. The organization called ICH (International council for harmonization of technical requirements for pharmaceuticals for human use) is a global organization that unites regulatory authorities and the pharmaceutical industry in the common goal of ensuring the development [...]
CLINICAL EVIDENCE FOR IVDs: THE NEW GOOD CLINICAL PRACTICES
Atty. Alessia Nuciari, director of compliance Meditrial. The in vitro diagnostics industry has undergone a substantial transformation. IVDR Regulation 746/2017, published in May 2017 and applied from May 26, 2022, introduced major changes in the industry. The main changes designate a strengthened system [...]
MEDICAL DEVICES AND MDR: SUSTAINABLE SOLUTIONS FOR SURVEILLANCE AND POSTMARKETING STUDIES
After more than 20 years, new legislation, the "Medical Device Regulation" (EU-MDR 2017/745), has come into force in Europe. The triggers for the initiation and implementation of this European law, which is much stricter than previous directives, were scandals related to the safety of medical [...]
OBSERVATIONAL STUDIES AND REGISTRIES: REAL WORLD EVIDENCE
Dr. Paola Antonini, Meditrial scientific director. If well designed, observational studies and registries produce treatment effect data comparable in importance to those in randomized controlled trials,[1] generating information missing in traditional interventional studies and real-world data to support marketing authorization. WHAT DESIGN? Observational [...]
THE NEW ROLE OF THE PATIENT AS AN ACTIVE PLAYER IN CLINICAL TRIALS
Research and innovation are based on rigorous clinical trials involving patients firsthand. The main actor in clinical trials is the patient affected by the disease under examination. Including the patient’s perspective allows us to reduce barriers that otherwise limit your participation and to introduce tools [...]
ITALY’S NEW DEVICE-VIGILANCE NETWORK: HOW TO PREPARE FOR IT
Italy has recently instituted substantial changes in national regulations on medical device vigilance in order to align our procedures with European Regulations 2017/475 for medical devices and 2017/476 for in vitro diagnostics. As of Oct. 16, 2022, the new rules of the March 21, 2022 [...]
NEW OPPORTUNITIES FOR SUCCESSFUL CLINICAL TRIALS.
The challenge of recruiting suitable patients into clinical trials has always been a significant obstacle to drug and medical device development programs. The difficulty of generating evidence delays the introduction of new medical interventions and results in high costs. In a new Covid-19 environment, [...]
DRUG SAFETY: THE CASE OF COVID-19 VACCINES
Over the course of two years of the pandemic, there have been heated debates about the safety and efficacy of the anti-Covid-19 vaccines. Even today, after more than 7 billion doses administered, issues continue to emerge about the available clinical evidence (Il Tempo). Reports often [...]
DIETARY SUPPLEMENTS, THE CLINICAL TRIALS ROADMAP.
Paola Antonini, Meditrial Scientific Director. Due to the pandemic and the information shared on social media, the increased attention of individuals to their own health and well-being has led to a considerable increase in the consumption of food supplements such as vitamins, minerals, immune [...]
CLINICAL DEVELOPMENT OF DRUGS AND MEDICAL DEVICES: AN OVERVIEW OF THE MOST INNOVATIVE AND INTERESTING ASPECTS.
Clinical development is a term traditionally used to define the entire process of bringing a new drug or medical device to market. It includes a pre-clinical phase to support human use and a clinical trial phase on patients, in compliance with current regulations. But today, [...]
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