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RECOVERY started in the UK in early 2020 as a clinical trial testing treatments for people admitted to hospital with COVID-19 pneumonia. Since then it has identified four life-saving treatments for COVID-19, and shown that several other commonly used treatments were not effective. RECOVERY is now open at sites across Europe, Asia and Africa and in 2023 expanded to test treatments of other types of pneumonia including influenza and non-viral community-acquired pneumonia.

Data from the trial are regularly reviewed so that any effective treatment can be identified quickly and made available to all patients. Please see our news page for results that RECOVERY has found. The RECOVERY Trial team constantly review information on new drugs and may include promising ones in the trial in future.

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Global platform trials like Solidarity help us prepare for future pandemics. Not only is this an important trial, in terms of potential new treatments for COVID-19, but it could open a new global approach to the robust evaluation of several therapeutics as we respond to this pandemic and prepare for future ones.tag_hash_107

Imatinib is a small molecule tyrosine kinase inhibitor, formulated as an oral chemotherapy drug used to treat certain types of cancer. Experimental and early clinical data suggest that imatinib reverses pulmonary capillary leak. A randomized clinical trial performed in the Netherlands reported that imatinib might confer clinical benefit in hospitalized Covid-19 patients, in the absence of safety issues.

WHO helps evaluate drugs by randomizing their effects on important outcomes. The WHO Solidarity PLUS trial involves collaboration among hundreds of hospitals in dozens of countries. It began by evaluating four repurposed drugs, and now guided by an independent expert group, is evaluating three new drugs in addition to the local Standard of Care.

Within each country, the national coordinator invites selected hospitals and helps them get ethical and regulatory approval and study drugs, then patient recruitment can begin. To facilitate collaboration even in overloaded hospitals, patient enrolment and randomization (via a cloud-based GCP-compliant platform) and all other trial procedures are greatly simplified, and no paperwork is required. Once consent has been obtained, electronic entry of anonymized details of a few key characteristics of each patient takes only a few minutes. At the end of patient entry, a random treatment allocation is generated.

Once electronic data collection has been completed the patient automatically enters the trial and a random allocation of their trial treatment is generated (by an algorithm that ensures eventual balance in the characteristics just recorded between each study drug and its controls) and displayed. The patients will be randomly allocated either to local Standard of Care alone or to local Standard of Care plus one of the study drugs.

tag_hash_108A global Data and Safety Monitoring Committee will keep the accumulating safety results and major outcome results under regular review. The WHO may recommend adding further treatment arms while the trial is in progress, if evidence emerges that there are suitable candidate therapeutics. Conversely, the WHO may decide to discontinue some treatment arms, especially if the Global Data and Safety Monitoring Committee reports, based on interim analyses, that one or other of the trial treatments definitely does or does not affect mortality.

In law, a trial is a coming together of parties to a dispute, to present information (in the form of evidence) in a tribunal, a formal setting with the authority to adjudicate claims or disputes. One form of tribunal is a court. The tribunal, which may occur before a judge, jury, or other designated trier of fact, aims to achieve a resolution to their dispute.

Hearings before administrative bodies may have many of the features of a trial before a court, but are typically not referred to as trials. An appeal (appellate proceeding) is also generally not deemed a trial, because such proceedings are usually restricted to a review of the evidence presented before the trial court, and do not permit the introduction of new evidence.

A criminal trial is designed to resolve accusations brought (usually by a government) against a person accused of a crime. In common law systems, most criminal defendants are entitled to a trial held before a jury. Because the state is attempting to use its power to deprive the accused of life, liberty, or property, the rights of the accused afforded to criminal defendants are typically broad. The rules of criminal procedure provide rules for criminal trials.

Although administrative hearings are not ordinarily considered trials, they retain many elements found in more "formal" trial settings. When the dispute goes to a judicial setting, it is called an administrative trial, to revise the administrative hearing, depending on the jurisdiction. The types of disputes handled in these hearings are governed by administrative law and auxiliarily by civil trial law.

Labor law (also known as employment law) is the body of laws, administrative rulings, and precedents which address the legal rights of, and restrictions on, working people and their organizations. As such, it mediates many aspects of the relationship between trade unions/labor unions, employers and employees. In Canada, employment laws related to unionized workplaces are differentiated from those relating to particular individuals. In most countries, however, no such distinction is made. However, there are two broad categories of labour law. First, collective labour law relates to the tripartite relationship between employee, employer and union. Second, individual labour law concerns employees' rights at work and through the contract for work. The labour movement has been instrumental in the enacting of laws protecting labour rights in the 19th and 20th centuries. Labour rights have been integral to social and economic development since the Industrial Revolution.

In civil law legal systems, the responsibility for supervising the investigation by the police into whether a crime has been committed falls on an examining magistrate or judge who then conducts the trial. The assumption is that the truth is more likely to emerge from an impartial and exhaustive investigation, both before and during the trial itself. The examining magistrate or judge acts as an inquisitor who directs the fact-gathering process by questioning witnesses, interrogating the suspect, and collecting other evidence. The lawyers who represent the interests of the state and the accused have a limited role to offer legal arguments and alternative interpretations to the facts that emerge during the process. All the interested parties are expected to cooperate in the investigation by answering the magistrate or judge's questions and, when asked, supplying all relevant evidence. The trial only takes place after all the evidence has been collected and the investigation is completed. Thus, most of the factual uncertainties will already be resolved, and the examining magistrate or judge will already have resolved that there is prima facie of guilt. Critics argue that the examining magistrate or judge has too much power with the responsibilities of both investigating and adjudicating on the merits of the case. Although lay assessors do sit as a form of jury to offer advice to the magistrate or judge at the conclusion of the trial, their role is subordinate. Further, because a professional has been in charge of all aspects of the case to the conclusion of the trial, there are fewer opportunities to appeal the conviction alleging some procedural error.

Either side may submit a motion for a mistrial; on occasion, the presiding judge may declare one on a motion of their own. If a mistrial is declared, the case at hand may be retried at the discretion of the plaintiff or prosecution, as long as double jeopardy does not bar that party from doing so.

Some other kinds of processes for resolving conflicts are also expressed as trials. For example, the United States Constitution requires that, following the impeachment of the president, a judge, or another federal officer by the House of Representatives, the subject of the impeachment may only be removed from office by an impeachment trial in the Senate.

In earlier times, disputes were often settled through a trial by ordeal, where parties would have to endure physical suffering in order to prove their righteousness; or through a trial by combat, in which the winner of a physical fight was deemed righteous in their cause.

The Patent Trial and Appeal Board (PTAB) conducts trials, including inter partes, post-grant, and covered business method patent reviews and derivation proceedings, hears appeals from adverse examiner decisions in patent applications and reexamination proceedings, and renders decisions in interferences.

The Trademark Trial and Appeal Board (TTAB) handles appeals involving applications to register marks, appeals from expungement or reexamination proceedings involving registrations, and trial cases of various types involving applications or registrations.

Our vision for the Trial Innovation Network is to address critical roadblocks in clinical trials and to accelerate the translation of novel interventions into life-saving therapies. The network will focus on operational innovation, operational excellence and collaboration while leveraging the expertise, diversity and broad reach of the CTSA Program. Features will include a single institutional review board system, master contracting agreements, quality-by-design approaches, and a focus on evidence-based strategies for recruitment and patient engagement.

ClinicalTrials.gov [ How to Use Search ]

This is a searchable registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals. 2351a5e196