The UK’s remarkable capability and capacity in clinical research was catapulted on to the world stage during the pandemic. The Recovery trial, led by Oxford University, studied existing drugs in seriously ill patients with Covid-19 and identified the first proven and effective life-saving treatments.
The Oxford/AstraZeneca vaccine was tested in a trial of more than 10,000 people across the UK, using repurposed research infrastructure in our hospitals and universities, and saved more lives globally than any other vaccine. The mix-and-match vaccine studies known as Com-Cov showed the world how different types of Covid-19 vaccines could be used together, while Cov-Boost provided key data on booster doses that has informed global vaccine policy.
The pandemic provides crystal clarity on the importance of clinical research for our health in the grave circumstances of a global crisis. But just as important are the regular research activities across all disease areas, from diabetes to cancer, which provide the innovations and advances that transform patient outcomes. The testing of new devices, drugs and vaccines is a core activity for our future health.
The UK has long been a leader in clinical research, with the National Institute for Health Research providing infrastructure and funding for people and research programmes across the NHS. But it is clear from the recent House of Lords science and technology committee inquiry into clinical academics in the NHS that all is not well in clinical research. Recent reports suggest the number of industry-backed clinical trials has fallen by 41% since 2017, and that trials are being conducted in other countries instead.
The review correctly identifies a multitude of factors that have led to a decline in clinical trials, including the pressures on the Medicines and Healthcare products Regulatory Agency, which has a reduced capacity and increased workload post-pandemic and post-Brexit, and other aspects of the national and local trial approvals systems, which have undermined the competitiveness of the UK clinical research environment.
Furthermore, there has been an ongoing decline in the number of senior clinical academics, that is doctors who also conduct academic research, leaving a leadership gap at the highest levels. Perhaps the greatest cause for concern is the huge pressure on the workforce in the NHS, which is chronically understaffed to deliver patient care and often does not have the time to provide the essential work of clinical research.
It is very difficult for doctors to undertake detailed discussions with patients as part of the research consent process, and manage the complexity of a highly regulated study, when there are so many sick patients needing urgent treatment, which rightly takes priority over research. And for clinical teams across the NHS, where research should be fully embedded in their work, time is not routinely allocated in their contract.
A key underlying problem across the whole system is also the general shortage of critical medical and nursing staff, who are also vital to running a trial. The reasons for this shortage are not simple – there are insufficient numbers being trained, some leave the NHS early in their careers or retire early or move to better-paid jobs elsewhere, compounded by a decline in European doctors coming to the UK.
On top of this, the ageing population will increase the system pressure over the next few decades, which means we need a large increase in capacity to get ahead of frontline patient care, let alone sustain world-class research. The current support for strike action appears to me to be as much about these workload pressures and dissatisfaction with conditions for the staff to best serve their patients as it is about the money.
The ambition for an NHS that can really transform health must be to develop the clinical research leaders for the next generation, and for every clinician in the NHS capable – that is, trained – and having the capacity, in terms of protected time allocated, to deliver clinical research. But this cannot be achieved while doctors and nurses are drowning in a chronically understaffed system.
The benefits are clear. Much has been made of the health and direct economic benefits that come with testing and developing cutting-edge drugs, including early access to new medicines, and the revenues the NHS generates by running clinical trials. But health innovation can also have wider economic benefits for society including a more economically productive healthy workforce, and reduced costs of social care that come with an expectation of a healthy old age. And in the US, there is evidence that hospitals with doctors active in clinical science have better patient outcomes. So we know research is essential for future health innovation.
The NHS is in a unique position to deliver world-class clinical research at a national scale. We need the system geared towards research as an essential part of clinical care, and research leaders incentivised to pursue a career that can have a positive impact on the health of wider society. But we can’t ask our doctors to drive research in the NHS if they have so many patients to see each day they can’t even find time for lunch.
Prof Sir Andrew Pollard was chief investigator of the Oxford Covid-19 vaccine trials and is director of the Oxford Vaccine Group
Source: The Guardian
Uwezo wa Uingereza katika utafiti wa kliniki ulipandishwa kwenye jukwaa la ulimwengu wakati wa janga hilo. Majaribio ya Uokoaji, yaliyoongozwa na Chuo Kikuu cha Oxford, yalijifunza dawa zilizopo kwa wagonjwa wagonjwa sana na COVID-19 na kutambua matibabu ya kwanza yaliyothibitishwa na yenye ufanisi ya kuokoa maisha. "Tiba ya chanjo ya Oxford na AstraZeneca ilijaribiwa kwa watu zaidi ya 10,000 kote Uingereza, ikitumia miundombinu ya utafiti iliyobadilishwa katika hospitali zetu na vyuo vikuu, na kuokoa maisha zaidi ulimwenguni kuliko chanjo nyingine yoyote. """ Mafunzo ya chanjo ya mchanganyiko na mechi inayojulikana kama ComCov ilionyesha ulimwengu jinsi aina tofauti za chanjo za COVID-19 zinaweza kutumiwa pamoja, wakati Cov-Boost ilitoa data muhimu juu ya dozi za booster ambazo zimearifu sera ya chanjo ya kimataifa. "Mgonjwa huu wa kisukari unatoa uwazi wa kioo juu ya umuhimu wa utafiti wa kliniki kwa afya yetu katika hali mbaya ya mgogoro wa kimataifa. """ Lakini muhimu pia ni shughuli za utafiti wa kawaida katika maeneo yote ya magonjwa, kutoka kisukari hadi kansa, ambayo hutoa uvumbuzi na maendeleo ambayo hubadilisha matokeo ya wagonjwa. """Kujaribu vifaa vipya, dawa na chanjo ni shughuli ya msingi kwa afya yetu ya baadaye." Kwa muda mrefu Uingereza imekuwa kiongozi katika utafiti wa kliniki, na Taasisi ya Taifa ya Utafiti wa Afya kutoa miundombinu na ufadhili kwa watu na mipango ya utafiti katika NHS. "Lakini ni wazi kutoka kwa uchunguzi wa hivi karibuni wa Kamati ya Sayansi na Teknolojia ya Baraza la Mabwana juu ya wasomi wa kliniki katika NHS kwamba ""si yote ni vizuri katika utafiti wa kliniki.""" Ripoti za hivi karibuni zinaonyesha idadi ya majaribio ya kliniki yanayoungwa mkono na tasnia imepungua kwa 41% tangu 2017, na kwamba majaribio yanafanywa katika nchi zingine badala yake. "Uhakiki huo unaonyesha kwa usahihi sababu nyingi ambazo zimesababisha kupungua kwa majaribio ya kliniki, pamoja na shinikizo kwa Shirika la Udhibiti wa Dawa na Bidhaa za Afya, ambalo lina uwezo mdogo na mzigo wa kazi uliopungua baada ya janga na baada ya Brexit, na mambo mengine ya mifumo ya kibali cha majaribio ya kitaifa na ya ndani, ambayo yameharibu ushindani wa mazingira ya utafiti wa kliniki wa Uingereza. """ Kwa kuongezea, kumekuwa na kupungua kwa idadi ya wasomi wakuu wa kliniki, ambayo ni madaktari ambao pia hufanya utafiti wa kitaaluma, wakiacha pengo la uongozi katika ngazi za juu. "Huenda sababu kubwa ya wasiwasi ni shinikizo kubwa juu ya wafanyakazi katika NHS, ambayo ni chronically under-staffed kutoa huduma ya mgonjwa na mara nyingi haina wakati wa kutoa kazi muhimu ya utafiti wa kliniki. """ Ni vigumu sana kwa madaktari kufanya majadiliano ya kina na wagonjwa kama sehemu ya mchakato wa idhini ya utafiti, na kusimamia utata wa utafiti uliowekwa kwa sheria nyingi, wakati kuna wagonjwa wengi wanaohitaji matibabu ya haraka, ambayo kwa haki inachukua kipaumbele juu ya utafiti. Kwa timu za kliniki katika NHS, ambapo utafiti unapaswa kuingizwa kikamilifu katika kazi yao, wakati haujagawanywa kwa kawaida katika mkataba wao. Tatizo kubwa katika mfumo huu ni ukosefu wa wafanyakazi wa matibabu na wauguzi ambao ni muhimu kwa ajili ya majaribio. """Sehemu kubwa ya upungufu huu ni kwamba kuna idadi ndogo ya madaktari wanaofundishwa, wengine huacha NHS mapema katika kazi zao au kustaafu mapema au kuhamia kazi zinazolipwa vizuri mahali pengine, pamoja na kupungua kwa madaktari wa Ulaya wanaokuja Uingereza." "Kwa kuongezea, idadi ya watu wanazeeka itaongeza shinikizo la mfumo katika miongo michache ijayo, ambayo inamaanisha tunahitaji ongezeko kubwa la uwezo wa kupata mbele ya huduma ya mstari wa mbele wa mgonjwa, bila kujali kudumisha utafiti wa kiwango cha ulimwengu. """ """Msaada wa sasa kwa mgomo unaonekana kwangu kuwa juu ya shinikizo hili la mzigo wa kazi na kutoridhika na hali kwa wafanyakazi kuwahudumia wagonjwa wao bora kama ni juu ya pesa." """Tamaa ya NHS ambayo inaweza kweli kubadilisha afya lazima iwe ya kuendeleza viongozi wa utafiti wa kliniki kwa kizazi kijacho, na kwa kila daktari katika NHS anayeweza - yaani, amezoezwa - na kuwa na uwezo, kwa suala la wakati uliotengwa, kutoa utafiti wa kliniki." Lakini hili haliwezi kupatikana wakati madaktari na wauguzi wanapoteza nguvu katika mfumo ambao umekuwa na uhaba wa wafanyakazi. Faida zake ni wazi. """Mengi yamefanywa juu ya faida za afya na za kiuchumi za moja kwa moja zinazokuja na majaribio na maendeleo ya dawa za kisasa, ikiwa ni pamoja na upatikanaji wa mapema wa dawa mpya, na mapato ya NHS inayotokana na majaribio ya kliniki." Lakini uvumbuzi wa afya unaweza pia kuwa na faida kubwa za kiuchumi kwa jamii, ikiwa ni pamoja na nguvu za kazi zenye afya na za kiuchumi, na kupunguza gharama za huduma za kijamii ambazo zinakuja na matarajio ya uzee wenye afya. Katika nchi za Ulaya, kuna ushahidi kwamba hospitali ambazo madaktari wao wanafanya kazi katika sayansi ya kliniki zina matokeo bora kwa wagonjwa. Kwa hivyo tunajua utafiti ni muhimu kwa uvumbuzi wa afya wa siku zijazo. NHS iko katika nafasi ya kipekee ya kutoa utafiti wa kliniki wa kiwango cha ulimwengu kwa kiwango cha kitaifa. Tunahitaji mfumo ulioelekezwa kwa utafiti kama sehemu muhimu ya huduma ya kliniki, na viongozi wa utafiti kuhamasishwa kufuata kazi ambayo inaweza kuwa na athari nzuri kwa afya ya jamii pana. Lakini hatuwezi kuwaomba madaktari wetu kuendesha utafiti katika NHS ikiwa wana wagonjwa wengi sana wa kuona kila siku hawawezi hata kupata wakati wa chakula cha mchana. Profesa Andrew Pollard, mtafiti mkuu wa majaribio ya chanjo ya Covid-19 ya Oxford, alisema kuwa kuna uwezekano wa kuwa na athari kubwa kwa afya ya watoto.