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The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.
Clinical
Clinical Rheumatology is an international English-language journal devoted to publishing original clinical investigation and research in the general field of rheumatology with accent on clinical aspects at postgraduate level.
The journal succeeds Acta Rheumatologica Belgica, originally founded in 1945 as the official journal of the Belgian Rheumatology Society. Clinical Rheumatology aims to cover all modern trends in clinical and experimental research as well as the management and evaluation of diagnostic and treatment procedures connected with the inflammatory, immunologic, metabolic, genetic and degenerative soft and hard connective tissue diseases.
CTSA Program institutions collaborate locally, regionally and nationally, fostering innovation in training and research methodologies. NCATS continues to build on the strong foundation of the CTSA Program to tackle system-wide scientific and operational problems to make the clinical and translational research enterprise more efficient. Learn more about the CTSA Program.
Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol, that is developed by the researcher or manufacturer. Before a clinical trial begins, researchers review prior information about the drug to develop research questions and objectives. Then, they decide:
The FDA review team has 30 days to review the original IND submission. The process protects volunteers who participate in clinical trials from unreasonable and significant risk in clinical trials. FDA responds to IND applications in one of two ways:
A clinical hold is rare; instead, FDA often provides comments intended to improve the quality of a clinical trial. In most cases, if FDA is satisfied that the trial meets Federal standards, the applicant is allowed to proceed with the proposed study.
This process continues until the developer decides to end clinical trials or files a marketing application. Before filing a marketing application, a developer must have adequate data from two large, controlled clinical trials.
Not all commercially available pulse oximeters have been cleared by the FDA. SpO2 readings obtained through non-FDA-cleared devices, such as over-the-counter sports oximeters or mobile phone applications, lack sufficient accuracy for clinical use. Abnormal readings on these devices should be confirmed with an FDA-cleared device or an arterial blood gas analysis.18,19
Asymptomatic SARS-CoV-2 infection can occur, although the percentage of patients who remain truly asymptomatic throughout the course of infection is variable and incompletely defined. The percentage of individuals who present with asymptomatic infection and progress to clinical disease is unclear. Some asymptomatic individuals have been reported to have objective radiographic findings consistent with COVID-19 pneumonia.20,21
Patients with COVID-19 are considered to have severe illness if they have SpO2 50%. These patients may experience rapid clinical deterioration and should be given oxygen therapy and be hospitalized. See Therapeutic Management of Hospitalized Adults With COVID-19 for treatment recommendations.
The clinical management of patients with COVID-19 who are in the intensive care unit should include treatment with immunomodulators, and, in some cases, the addition of remdesivir. These patients should also receive treatment for any comorbid conditions and nosocomial complications. For more information, see Critical Care for Adults and Therapeutic Management of Hospitalized Adults With COVID-19.
Observational studies and results from clinical trials of therapeutic agents have described SARS-CoV-2 viral or COVID-19 symptom rebound in patients who have completed treatment for COVID-19.44-46 Viral and symptom rebounds have also occurred when anti-SARS-CoV-2 therapies were not used.46,47 Typically, this phenomenon has not been associated with progression to severe COVID-19.
Patients who are immunocompromised may experience prolonged shedding of SARS-CoV-2 with or without COVID-19 symptoms.48,49 Prolonged viral shedding may affect SARS-CoV-2 testing strategies and isolation duration for these patients. In some cases, the prolonged shedding may be associated with persistent COVID-19 symptoms. Currently, the evidence is insufficient to guide any clinical recommendations for managing the treatment of these individuals. Limited data support using combination antiviral therapy or extending the duration of COVID-19 therapies beyond the durations authorized or approved by the FDA. See Special Considerations in People Who Are Immunocompromised for more information on the clinical management of people who are immunocompromised.
Essential Skills for Conducting Clinical & Translational Research offers study team members and early-stage investigators a greater understanding of the processes and capabilities needed to successfully conduct clinical research.
Participants will be introduced to the clinical and translational research domains before exploring ways to effectively participate, collaborate, and communicate within a research team and with key stakeholders.
The content in this course is ideal for those conducting clinical and translational research, including but not limited to: clinical trials, natural history studies, outcome studies, and biomarker studies.
The European Medicines Agency (EMA) relies on the results of clinical trials carried out by pharmaceutical companies to reach its opinions on the authorisation of medicines. Although clinical trials are authorised at national level in the European Union (EU), EMA plays a key role in further developing the EU as a competitive centre for innovative clinical trials, and in maintaining IT systems for the coordination of clinical trials.
Sponsors can adjust the way they run clinical trials that have been affected by the war in Ukraine using the experience gained during the COVID-19 pandemic. They can also apply the approaches and flexibilities agreed in the context of the pandemic.
Guidance is also available from EMA's Biostatistics Working Party on actions sponsors of affected clinical trials can take to help ensure the integrity of their studies and the interpretation of the study results while safeguarding the safety of trial participants as a first priority:
Regardless of where they are conducted, all clinical trials included in applications for marketing authorisation for human medicines in the European Union (EU) / European Economic Area (EEA) must have been carried out in accordance with the requirements set out in Annex 1 of Directive 2001/83/EC. This means that:
EMA's Committee for Medicinal Products for Human Use (CHMP) is responsible for conducting the assessment of a human medicine for which an EU-wide marketing authorisation is sought. As part of its scientific evaluation work, the CHMP reviews the clinical trial data included in the application.
Clinical trial data is included in clinical-study reports that form a large part of the application dossiers submitted by applicants such as pharmaceutical companies and small and medium enterprises applying for a marketing authorisation via the Agency.
Furthermore, the Agency manages two clinical trial databases, EudraCT and the Clinical Trial Information System. EMA also co-leads the business change programme Accelerating Clinical Trials in the EU (ACT EU), together with the Heads of Medicines Agencies (HMA) and the European Commission.
EMA's Emergency Task Force (ETF) can provide support to clinical trial sponsors for all medicines intended to target a potential or declared public health emergency. This is in line the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123).
Guidance is also available on the actions that sponsors of affected clinical trials should take to help ensure the integrity of their studies and the interpretation of the study results while safeguarding the safety of trial participants as a first priority:
The development of this paper took account of the perspectives of all areas of the research community on decentralised clinical trials, including at a multi-stakeholder workshop hosted by ACT EU in October 2022.
The Regulation is part of a broad initiative to transform the EU / EEA clinical trials environment in support of large clinical trials in multiple European countries, to the benefit of medical innovation and patients.
The Clinical Trials Information System (CTIS) supports interactions between clinical trial sponsors (researchers or companies that run clinical trials and collect and analyse the data) and regulatory authorities in the EU Member States and EEA countries, throughout the lifecycle of a clinical trial.
EMA and national competent authorities enabled these compliance rates through reminders sent to clinical trials sponsors. A full list of clinical trials for which sponsors did not follow up on these reminders is available on the European Clinical Trials Register.
From October 2020, sponsors can also post results of clinical trials that ended prematurely, whether they were approved but never started or started but terminated early. Sponsors should provide the reasons for the premature end and any partial results, if available.
It is responsible for harmonising and optimising the regulatory environment while assuring the protection of rights, safety and wellbeing of clinical trial participants and ensuring the generation of robust data.
A separate clinical case definition for children and adolescents has been formed, through a process of expert consensus, which recognizes the unique health needs and challenges of this group of people. 041b061a72