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| Thousands of lives put at risk by clinical trials system that is 'not fit for purpose' | |
| (about 3 hours later) | |
| A major outbreak of infectious disease could sweep through the country and leave thousands dead or ill because hospitals cannot test life-saving treatments quickly enough, senior doctors have told the Guardian. | A major outbreak of infectious disease could sweep through the country and leave thousands dead or ill because hospitals cannot test life-saving treatments quickly enough, senior doctors have told the Guardian. |
| Profound delays in the approvals process for clinical trials mean doctors face months of form-filling and administrative checks that make it impossible to run crucial tests in good time, said Jeremy Farrar, in his first major interview as director of the Wellcome Trust. | Profound delays in the approvals process for clinical trials mean doctors face months of form-filling and administrative checks that make it impossible to run crucial tests in good time, said Jeremy Farrar, in his first major interview as director of the Wellcome Trust. |
| Farrar, a world expert on infectious diseases at Oxford University, has taken over from Sir Mark Walport, who left the medical charity to become the government's chief science adviser. | Farrar, a world expert on infectious diseases at Oxford University, has taken over from Sir Mark Walport, who left the medical charity to become the government's chief science adviser. |
| Farrar's warning is backed by other senior figures including Sir Michael Rawlins, president of the Royal Society of Medicine, and Prof Peter Openshaw, who advised the government during the pandemic flu outbreak in 2009. | Farrar's warning is backed by other senior figures including Sir Michael Rawlins, president of the Royal Society of Medicine, and Prof Peter Openshaw, who advised the government during the pandemic flu outbreak in 2009. |
| Farrar said the unwieldy system puts public health at risk, particularly when pandemic flu and other infectious diseases strike, because doctors have no idea which interventions work. | Farrar said the unwieldy system puts public health at risk, particularly when pandemic flu and other infectious diseases strike, because doctors have no idea which interventions work. |
| "The systems we have got in place are not fit for purpose when the situation is moving quickly," said Farrar. "We have nothing that enables us to respond in real time." | "The systems we have got in place are not fit for purpose when the situation is moving quickly," said Farrar. "We have nothing that enables us to respond in real time." |
| The Department of Health on Monday approved proposals from the Health Research Authority to streamline clinical trials, but some leading experts argue that far more work is needed within the NHS to fast-track trials in an emergency. | The Department of Health on Monday approved proposals from the Health Research Authority to streamline clinical trials, but some leading experts argue that far more work is needed within the NHS to fast-track trials in an emergency. |
| An emerging infection such as bird flu, Sars or pandemic influenza could spread across Britain and burn itself out within the space of eight weeks. | |
| But doctors hoping to test drugs or other interventions in patients can face delays of more than a year before they can recruit a single case. | |
| The delays mean that doctors have almost no hope of learning which treatments might save lives during an outbreak because patients will have recovered or died before a trial can start. | The delays mean that doctors have almost no hope of learning which treatments might save lives during an outbreak because patients will have recovered or died before a trial can start. |
| Farrar said the system needed a radical overhaul so emergency trials could launch within 24 hours of an epidemic emerging. "Getting this information early on is critical to inform what we do and how we treat patients. Without it we are completely in the dark," he said. | Farrar said the system needed a radical overhaul so emergency trials could launch within 24 hours of an epidemic emerging. "Getting this information early on is critical to inform what we do and how we treat patients. Without it we are completely in the dark," he said. |
| Pandemic influenza is considered the most serious civil emergency risk that Britain faces, but other infections, such as novel coronaviruses and the alarming rise of drug-resistant pathogens, are also a serious threat. Clinical trials need formal approval from the NHS and other bodies before doctors can recruit patients, but the process is held up at almost every stage. Researchers must apply for grants, submit study protocols and patient consent forms, gain ethical approval, find hospitals with the right facilities, equipment, supplies, staff and patients, and then sign legal contracts with them all. | |
| The process is necessarily thorough to protect patients and hospitals from litigation. Trials can go spectacularly wrong, as happened in 2006 when six young men were nearly killed by an experimental drug in a trial at Northwick Park hospital in north London. | The process is necessarily thorough to protect patients and hospitals from litigation. Trials can go spectacularly wrong, as happened in 2006 when six young men were nearly killed by an experimental drug in a trial at Northwick Park hospital in north London. |
| The 2002 Sars pandemic killed 774 people and infected more than 8,000. Had the virus not been contained it could have killed far more. The reason the death toll was not higher was that patients were most infectious when they were most sick, so isolating the ill stopped the virus spreading. | The 2002 Sars pandemic killed 774 people and infected more than 8,000. Had the virus not been contained it could have killed far more. The reason the death toll was not higher was that patients were most infectious when they were most sick, so isolating the ill stopped the virus spreading. |
| "There is no doubt we were very lucky with Sars," said Farrar. "But nobody knows where it has gone and we don't have a vaccine. If it were to come back tomorrow and I got infected, the doctor treating me wouldn't have a clue which drug, if any, to give me." | "There is no doubt we were very lucky with Sars," said Farrar. "But nobody knows where it has gone and we don't have a vaccine. If it were to come back tomorrow and I got infected, the doctor treating me wouldn't have a clue which drug, if any, to give me." |
| Without hard evidence, the government's preparedness rests on educated guesses. The Department of Health spent £424m stockpiling Tamiflu (oseltamivir) for a flu pandemic. But the lack of trials in sick patients means doctors disagree on how well the drug works. | Without hard evidence, the government's preparedness rests on educated guesses. The Department of Health spent £424m stockpiling Tamiflu (oseltamivir) for a flu pandemic. But the lack of trials in sick patients means doctors disagree on how well the drug works. |
| A 2011 report from the Academy of Medical Sciences (AMS) raised major concerns about delays to clinical trials. The report quoted Cancer Research UK data that found the typical time taken to launch a trial and treat the first patient was a staggering 621 days. The bulk of that time was spent obtaining NHS approval. The time has come down since, to around 18 months, but has not improved much in the past year or so. | A 2011 report from the Academy of Medical Sciences (AMS) raised major concerns about delays to clinical trials. The report quoted Cancer Research UK data that found the typical time taken to launch a trial and treat the first patient was a staggering 621 days. The bulk of that time was spent obtaining NHS approval. The time has come down since, to around 18 months, but has not improved much in the past year or so. |
| Sir Michael Rawlins, president of the Royal Society of Medicine, who chaired the report, said progress was disappointing. "It's going in the right direction, but it's painfully slow," he said. | Sir Michael Rawlins, president of the Royal Society of Medicine, who chaired the report, said progress was disappointing. "It's going in the right direction, but it's painfully slow," he said. |
| The Health Research Authority was set up in response to the AMS report and charged with streamlining approval times. It has already cut delays that held up ethical approval. One change was to hold weekly meetings of ethical committees to consider and approve trials submitted in the days beforehand, and a system for convening ethical committees virtually when a trial is urgent. One trial to look at the effect of a vaccine in pandemic influenza received ethical approval in two days. | The Health Research Authority was set up in response to the AMS report and charged with streamlining approval times. It has already cut delays that held up ethical approval. One change was to hold weekly meetings of ethical committees to consider and approve trials submitted in the days beforehand, and a system for convening ethical committees virtually when a trial is urgent. One trial to look at the effect of a vaccine in pandemic influenza received ethical approval in two days. |
| But the major delays are not with ethical approval, but sign-off from the NHS centres that host trials. It is here that the HRA proposals aim to make their greatest impact. Instead of individual NHS hospitals duplicating each other's work by independently reviewing, querying and finally approving a trial, the HRA will act as a central authority, giving a single sign-off for all participating hospitals. | But the major delays are not with ethical approval, but sign-off from the NHS centres that host trials. It is here that the HRA proposals aim to make their greatest impact. Instead of individual NHS hospitals duplicating each other's work by independently reviewing, querying and finally approving a trial, the HRA will act as a central authority, giving a single sign-off for all participating hospitals. |
| Relieved of that workload, hospitals can focus on the practicalities, such as obtaining trial drugs and making sure patients are enrolled. If the health department agrees to the plans, a simple trial could be approved within 25 days. | Relieved of that workload, hospitals can focus on the practicalities, such as obtaining trial drugs and making sure patients are enrolled. If the health department agrees to the plans, a simple trial could be approved within 25 days. |
| "We will give researchers a lot more confidence that the NHS can respond if the HRA is doing the greater part of the approving," said Janet Wisely, chief executive of the HRA. | "We will give researchers a lot more confidence that the NHS can respond if the HRA is doing the greater part of the approving," said Janet Wisely, chief executive of the HRA. |
| She said that ultimately, they should be able to approve emergency trials within 24 hours. "If you are intending to treat someone in a 24-hour timeframe then research should match that. It's a challenge, but it's what we should aim for," she said. | She said that ultimately, they should be able to approve emergency trials within 24 hours. "If you are intending to treat someone in a 24-hour timeframe then research should match that. It's a challenge, but it's what we should aim for," she said. |
| Farrar wants more trials pre-approved so that doctors can start emergency tests in patients the moment an outbreak is identified. "We need generic protocols which have been pre-approved by ethics committees and institutions at a national level. All the information, from what samples to take to the forms we'd record patient data on, would be openly available. Then, in an emergency, a group that has worked on the top three or four interventions can start enrolling patients within 24 hours," he said. "There are groups trying to address this, but it's nowhere near there yet." | Farrar wants more trials pre-approved so that doctors can start emergency tests in patients the moment an outbreak is identified. "We need generic protocols which have been pre-approved by ethics committees and institutions at a national level. All the information, from what samples to take to the forms we'd record patient data on, would be openly available. Then, in an emergency, a group that has worked on the top three or four interventions can start enrolling patients within 24 hours," he said. "There are groups trying to address this, but it's nowhere near there yet." |