A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. ClinicalTrials.gov includes both interventional and observational studies.

In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.

Clinical trials used in drug development are sometimes described by phase. These phases are defined by the Food and Drug Administration (FDA).

Some people who are not eligible to participate in a clinical trial may be able to get experimental drugs or devices outside of a clinical trial through expanded access. See more information on expanded access from the FDA.

In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions (which can include medical products such as drugs or devices) or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial). For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health.

Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals.

Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to Federal agencies such as the National Institutes of Health, the U.S. Department of Defense, and the U.S. Department of Veterans Affairs. Doctors, other health care providers, and other individuals can also sponsor clinical research.

Clinical studies can take place in many locations, including hospitals, universities, doctors' offices, and community clinics. The location depends on who is conducting the study.

The length of a clinical study varies, depending on what is being studied. Participants are told how long the study will last before they enroll.

In general, clinical studies are designed to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions. Some common reasons for conducting clinical studies include:

• Evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or condition
• Finding ways to prevent the initial development or recurrence of a disease or condition. These can include medicines, vaccines, or lifestyle changes, among other approaches.
• Evaluating one or more interventions aimed at identifying or diagnosing a particular disease or condition
• Examining methods for identifying a condition or the risk factors for that condition 
• Exploring and measuring ways to improve the comfort and quality of life through supportive care for people with a chronic illness

A clinical study is conducted according to a research plan known as the protocol. The protocol is designed to answer specific research questions and safeguard the health of participants. It contains the following information:

• The reason for conducting the study
• Who may participate in the study (the eligibility criteria)
• The number of participants needed 
• The schedule of tests, procedures, or drugs and their dosages
• The length of the study 
• What information will be gathered about the participants

Clinical studies have standards outlining who can participate. These standards are called eligibility criteria and are listed in the protocol. Some research studies seek participants who have the illnesses or conditions that will be studied, other studies are looking for healthy participants, and some studies are limited to a predetermined group of people who are asked by researchers to enroll.

Eligibility. The factors that allow someone to participate in a clinical study are called inclusion criteria, and the factors that disqualify someone from participating are called exclusion criteria. They are based on characteristics such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Informed consent is a process used by researchers to provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll or continue to participate in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions, and activities to measure participant understanding. In general, a person must sign an informed consent document before joining a study to show that he or she was given information on the risks, potential benefits, and alternatives and that he or she understands it. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over. See the Questions to Ask section on this page for questions to ask a health care provider or researcher about participating in a clinical study.

Institutional review boards. Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of doctors, researchers, and members of the community. Its role is to make sure that the study is ethical and that the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other responsibilities. The IRB also reviews the informed consent document. 

In addition to being monitored by an IRB, some clinical studies are also monitored by data monitoring committees (also called data safety and monitoring boards).

Various Federal agencies, including the Office of Human Subjects Research Protection and FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.

Typically, participants continue to see their usual health care providers while enrolled in a clinical study. While most clinical studies provide participants with medical products or interventions related to the illness or condition being studied, they do not provide extended or complete health care. By having his or her usual health care provider work with the research team, a participant can make sure that the study protocol will not conflict with other medications or treatments that he or she receives.

Participating in a clinical study contributes to medical knowledge. The results of these studies can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions. 

Clinical trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. Sometimes, the safety and the effectiveness of the experimental approach or use may not be fully known at the time of the trial. Some trials may provide participants with the prospect of receiving direct medical benefits, while others do not. Most trials involve some risk of harm or injury to the participant, although it may not be greater than the risks related to routine medical care or disease progression. (For trials approved by IRBs, the IRB has decided that the risks of participation have been minimized and are reasonable in relation to anticipated benefits.) Many trials require participants to undergo additional procedures, tests, and assessments based on the study protocol. These requirements will be described in the informed consent document. A potential participant should also discuss these issues with members of the research team and with his or her usual health care provider.

Anyone interested in participating in a clinical study should know as much as possible about the study and feel comfortable asking the research team questions about the study, the related procedures, and any expenses. The following questions may be helpful during such a discussion. Answers to some of these questions are provided in the informed consent document. Many of the questions are specific to clinical trials, but some also apply to observational studies. 

• What is being studied?
• Why do researchers believe the intervention being tested might be effective? Why might it not be effective? Has it been tested before?
• What are the possible interventions that I might receive during the trial? 
• How will it be determined which interventions I receive (for example, by chance)? 
• Who will know which intervention I receive during the trial? Will I know? Will members of the research team know? 
• How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?
• What will I have to do?
• What tests and procedures are involved?
• How often will I have to visit the hospital or clinic? 
• Will hospitalization be required?
• How long will the study last?
• Who will pay for my participation?
• Will I be reimbursed for other expenses?
• What type of long-term follow-up care is part of this trial? 
• If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?
• Will results of the study be provided to me?
• Who will oversee my medical care while I am participating in the trial?
• What are my options if I am injured during the study?

In December 2020 a new variant of SARS-CoV-2 was reported in South Africa. The mutation, known as 501.V2, is said to be more aggressive and dangerous for young men. The highly transmissible new strain could also be resistant to existing COVID-19 vaccines.

On Monday, the head of the World Health Organization (WHO), Tedros Adhanom Ghebreyesus, stressed that the emergence of new coronavirus mutations poses the problem of the effectiveness of existing vaccines. At a media briefing he suggested that it was "concerning news" that existing vaccines may not work as well against the new variant, first detected in South Africa.

Tedros outlined an essential need for vaccine manufacturers to upgrade their existing shots, saying booster shots would most likely be necessary as the new strain is quickly spreading throughout the world and could become the predominant coronavirus variant.

According to the WHO chief, South Africa's prohibition of the AstraZeneca vaccine following earlier reports that the drug does not protect against mild to moderate Covid-19 infections, is “a reminder that we need to do everything we can to reduce circulation of the virus with proven public health measures.”

He added that WHO will announce its decision on whether it will recommend the AstraZeneca vaccine for emergency use “in the next few days.” If the drug is approved, poor countries will receive the shots under COVAX, a UN-backed effort to distribute COVID-19 vaccines worldwide.

Read more:

https://sputniknews.com/world/202102081082021666-who-comments-new-covid-...

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A month-long investigation into the origins of COVID-19 has dismissed suggestions that it could have been introduced to humans through a laboratory leak, finding it was most likely to have been transmitted through an intermediate animal host and may have been spread through frozen food.

The World Health Organisation and Chinese investigators on Tuesday announced several key findings including that the virus was likely to have been active outside the Wuhan market for weeks before cases were first detected. The team raised the possibility that the virus could have been present in other regions or countries before the first cases were reported in Wuhan.

But the zoonotic origin of the virus remains a mystery, with investigators finding no clear link to bats, pangolins or other wild animals, while calling for more samples to be taken from felines and other species.

China team lead Dr Liang Wannian, a senior official at the National Health Commission, said mortality rates in Wuhan show there was not likely to be a large spread of the disease or unidentified respiratory pneumonia between October and December 2019.

“There is no indication of [COVID-19] in the population before December 2019,” he said.

Dr Liang said it was not possible on the basis of the epidemiological work to determine how COVID-19 was introduced to the Wuhan market.

“While some of the early cases had an association with the market, others were associated with other markets and others had no association with markets at all,” he said.

Speaking from the Hilton Optics Valley Hotel in Wuhan, WHO team leader Peter Ben Embarek, a scientist for food safety and zoonosis, said a laboratory incident hypothesis was extremely unlikely to explain the introduction of the virus. The Trump administration had previously targeted the Wuhan Institute of Virology as a potential first exposure site for the virus.

“Therefore it is not a hypothesis we suggest to support for our future work,” he said.

He said that the most likely hypothesis was a transmission to humans via an intermediate animal. He added that the virus could have been spread through frozen animal product.

“The market was dealing primarily with frozen animal product but there were also vendors selling products from domesticated wildlife and imported products,” he said.

“There is the potential to continue to follow this lead and animals that were supplied to the market in frozen and other semi processed or raw form. We have to do much more work on the cold-food product chain.”

Dr Embarek said it was possible “the virus was also present in other places and individuals in other countries” and urged further investigation.

“Did we change the picture dramatically compared to what we had before? I don’t think so,” he said. “Did we improve our understanding and add details? Absolutely.”

Read more:

https://www.smh.com.au/world/asia/who-releases-report-on-covid-19-origin-after-independent-investigation-in-wuhan-20210209-p570yg.html

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The Department of Homeland Security (DHS) is not requiring all border crossers to get tested for the Chinese coronavirus before releasing them into the United States, the agency confirmed to Breitbart News.

A DHS spokesperson responded to a question from Breitbart News about whether President Joe Biden supported mandatory coronavirus testing for border crossers released into the U.S. interior.

“As Customs and Border Protection always has, it adjusts resources as needed to meet the demand at the border and regularly screens individuals for signs of health issues when they are encountered, including COVID-19,” the spokesperson told Breitbart News. “Anyone who shows signs of illness receives the appropriate medical treatment.”

The response confirms that untested border crossers are continuing to be released into the U.S. interior as long as they are not exhibiting coronavirus symptoms.

On the other hand, DHS officials have said that migrants enrolled in the now-defunct Remain in Mexico program, set to be released into the U.S. interior this month, will have to undergo coronavirus testing. Internal communications reviewed by Breitbart News, though, show no mentions of this requirement.

“Individuals processed through this program will be tested for COVID-19 before entering the United States,” the administration confirmed.

Most border crossers apprehended and released at the southern border also appear to enjoy a less stringent testing standard that even foreign travelers to the U.S. experience.

Shortly after he was inaugurated, President Joe Biden signed an executive order requiring foreign travelers to the U.S. “to the extent feasible” to produce a negative test for the coronavirus prior to entry and to either isolate or quarantine themselves for several days after they arrive.

This week, Breitbart News reported that 25,600 migrants enrolled in the Remain in Mexico program are to be released into communities in El Paso and Brownsville, Texas, and San Diego, California. The mass release effort comes after Biden ended the program despite its effectiveness in drastically reducing asylum fraud.

Data from the Transactional Records Access Clearinghouse at Syracuse University (TRAC) has previously revealed that about 85 percent of asylum cases by Central Americans are rejected and a total of nearly 70,000 migrants were returned to their native countries after not meeting asylum requirements since the program was created.

Read more:

https://www.breitbart.com/politics/2021/02/15/bidens-dhs-releasing-border-crossers-into-u-s-without-coronavirus-tests/

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Border staff received guidelines on how to execute England’s new “red list” quarantine rules in an email two and a half hours before they came into force in a rollout that one worker described as “an absolute joke”.

British and Irish nationals or UK residents arriving from a list of 33 countries are now required to book a 10-day quarantine package costing £1,750 per adult, as the government seeks to limit the spread of new and potentially more dangerous coronavirus variants arriving from abroad.

Read more:

https://www.theguardian.com/world/2021/feb/15/hotel-quarantine-rollout-in-england-an-absolute-joke-says-border-official

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A mysterious flesh-eating bug has spread to non-coastal Melbourne suburbs, prompting a fresh health alert.

Multiple cases of Buruli ulcer, commonly found in stagnant water, have been identified in Essendon, Moonee Ponds and Brunswick West.

Chief health officer Brett Sutton said the new cases meant Melbourne’s inner north was now an area of interest.

“This is the first non-coastal area in Victoria to be recognised as a potential area of risk,” he said.

“However, the risk of transmission in these areas is considered low.”

Chief Health Officer Advisory: 
Several cases of Buruli Ulcer have occurred in the Essendon, Moonee Ponds and Brunswick West areas of inner Melbourne.

Find out more: https://t.co/prJ3MO3nbJpic.twitter.com/qLvG0BOT20

— VicGovDH (@VicGovDH) February 23, 2021

All the identified cases had travelled to known Buruli ulcer risk areas which include Melbourne’s Mornington Peninsula, Bellarine Peninsula, south-east bayside suburbs and East Gippsland.

But Professor Sutton said genetic analysis of the bacteria from each person “suggests a common source of infection in the area”.

“The potential source of M. ulcerans in Melbourne’s inner north has not been established, although the bacteria were isolated from the faeces of a local possum,” he said.

“The disease is not transmissible from person to person and there is no evidence of transmission from possums directly to humans.”

Read more:

https://thenewdaily.com.au/news/2021/02/23/flesh-eating-bug-melbourne-alert/

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