Tagged / clinical trials

Future of Complex Innovative Trial Design

international

The latest Faculty of Health & Social Sciences (FHSS) publication on the last day of March is an editorial in the Nepal Journal of  Epidemiology.  This editorial ‘The Promising Future for Complex Innovative Trial Design in Clinical Research’ has as its lead author, FHSS’s Visiting Faculty Dr. Brijesh Sathian.

 

Reference:

  1. Sathian, B., van Teijlingen, E., Banerjee, I., Asim, M., Kabir, R. (2023) The Promising Future for Complex Innovative Trial Design in Clinical Research. Nepal Journal of  Epidemiology, 13(1):1256-1257.

 

Request for feedback – MHRA clinical trials consultation

NHS, Research Ethics

The Medicines & Healthcare products Regulatory Agency (the MHRA) have launched a public consultation into clinical trials.

The aim of the consultation is to streamline approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement.

There will be a 1 hour meeting on Monday 14th February at 1pm until 2pm, where you can offer your thoughts and feedback for BU’s institutional response.

If you wish to attend the meeting, please get in touch to be added to the invitation.

If you are unable to make the above time but wish to offer your thoughts, please email clinicalresearch@bournemouth.ac.uk to ensure your feedback is included.

Request for feedback – MHRA clinical trials consultation

NHS, Research Ethics

The Medicines & Healthcare products Regulatory Agency (the MHRA) have launched a public consultation into clinical trials.

The aim of the consultation is to streamline approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement.

There will be a 1 hour meeting on Monday 14th February at 1pm until 2pm, where you can offer your thoughts and feedback for BU’s institutional response.

If you wish to attend the meeting, please get in touch to be added to the invitation.

If you are unable to make the above time but wish to offer your thoughts, please email clinicalresearch@bournemouth.ac.uk to ensure your feedback is included.

UK government sets out bold vision for the future of clinical research delivery

innovation, NHS, Research Ethics

Patients, clinicians and researchers across the whole of the UK are set to benefit from the ambitious vision for the future of clinical research delivery according to this press release from the UK Government.

The plan includes:

  • Strengthening the UK’s renowned research expertise as a world-leader in designing and delivering research
  • An ambitious vision to unlock the true potential of research putting patients and NHS at its heart
  • Using the lessons from COVID-19 to build back better, the government will create a patient-centred, pro-innovation and digitally-enabled research environment.

Saving and improving lives: the future of UK clinical research delivery, published on March 23rd was developed by the UK government and devolved administrations. The policy paper sets out how they will deliver faster, more efficient and more innovative research – from the streamlining of costing, contracting and approvals processes to the Health Research Authority’s rapid ethics review pilot, which aims to halve the time to provide a final opinion for research applications.

Using best practice, it is hoped that participating in research will become more accessible, increasing diversity and allowing more people across the whole of the UK to take part. They will work with Centres of Excellence, such as the Centre for BME Health in Leicester, and there will be more support for research in more diverse and under-served communities and innovative approaches.

The NHS will be encouraged to put delivery of research at the heart of everything they do, making it an essential and rewarding part of effective patient care. This included building a culture across the NHS and all health and care settings that is positive about research, where all staff feel empowered and supported to take part in clinical research delivery as part of their job.

The vision is built around 5 key themes:

  1. Clinical research embedded in the NHS: to create a research-positive culture in which all health and care staff feel empowered to support and participate in clinical research as part of their job.
  2. Patient-centred research: to make access and participation in research as easy as possible for everyone across the UK, including rural, diverse and under-served populations.
  3. Streamlined, efficient and innovative research: so the UK is seen as the best place in the world to conduct fast, efficient and cutting-edge clinical research.
  4. Research enabled by data and digital tools: to ensure the UK has the most advanced and data-enabled clinical research environment in the world, building on our unique data assets to improve health and care.
  5. A sustainable and supported research workforce: which offers rewarding opportunities and exciting careers for all healthcare and research staff of all professional backgrounds – across both commercial and non-commercial research.

The vision reflects the ambition of all 4 UK governments and has been developed through a broad cross-sector approach involving NHS, medical research charities, life sciences industry and academia. Continued collaboration across sectors and organisations will ensure the key action areas will be delivered.

Remember – support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Research Governance and Integrity website.

COVID-19 affects research into other diseases

international, Publishing, Research Integritiy, Training, writing

A systematic review published late last week assesses the impact of the COVID-19 pandemic on on-going and new clinical trials and research on a range of diseases [1]. The COVID-19 pandemic has resulted in a series of public health policies, including lock down, that have crippled the healthcare systems of many countries. These measures hugely impact on study participants, care providers, researchers, trial sponsors, and research organizations conducting clinical trials. This pandemic has a substantial impact on the trial sites as they experience difficulty in the continuation of trial activities which eventually hampers the progress of the trial and delays study timelines. Most sites are struggling due to delayed subject enrolment, shortfalls in monitoring, and risks of compromised data integrity, and this situation also has a negative impact on the start of future. Researchers are also concerned regarding the delay or cancellations of trials in the pandemic, which will have financial consequences for research organizations/human resources.

According to one survey, about two-thirds of the respondents have stopped or will soon halt subject enrolment in ongoing clinical trials, one-third halted randomization, and fifty percent of respondents are delaying or planning to delay the studies.  Adopting new approaches and understanding the key risk indicators will help managers support trial sites with flexibility and ingenuity. For instance, switching patient site visits to new-trial virtualization, and telemedicine to interact with patients will help manage current clinical trials also beneficial for the post-pandemic era.

 

Reference:

  1. Sathian B, Asim M,  Banerjee I, Pizarro AB, Roy B, van Teijlingen ER, Borges do Nascimento IJ, Alhamad HK.  Impact of COVID-19 on clinical trials and clinical research: A systematic review. Nepal J Epidemiol. 2020;10(3); 878-887

 

HRA Research Transparency Strategy Group minutes available

NHS, open access, Research Ethics

The Health Research Authority (HRA) has formed the Research Transparency Strategy Group in response to the House of Commons Science and Technology Committee Report on clinical trials transparency.

You can read more about the first meeting of the expert group, including the minutes by clicking here

In relation to this, the HRA’s Director of Policy, Juliet Tizzard has released a blog post entitled What’s the point of research transparency? You can read the post here.

BU has access to the ClinicalTrials.gov system so get in touch if you would like access. This is a great opportunity to register your study and study results in the public domain. On ClinicalTrials.gov, it is free to do so.
Despite the name, the system may be used for other clinical research projects.

HRA Update – Travel insurance and participation in clinical trials

NHS

Please see below for a message from the NIHR Workforce Development team –

‘We are pleased to inform you that the Association of British Insurers (ABI) have confirmed to the Health Research Authority that participation in clinical trials does not affect eligibility criteria for travel insurance and have now withdrawn their guidance document “Clinical research trials and insurance”.

ABI agree that taking part in a clinical trial should not affect insurance cover if the medical condition itself doesn’t. Please share the following message with your teams, organisations etc.

‘When individuals apply for travel insurance, insurers will typically ask questions about an individual’s health in order to make an accurate risk assessment. This risk assessment takes into consideration the health of the individual and the insurer will often ask questions about any pre-existing health conditions and medical treatments for those conditions. Travel insurers do not typically ask about clinical research trials. Where an insurer does ask an individual about their participation in clinical research trials, the insurer must ensure the question is clear and the individual should answer it accurately and honestly”.

If you are aware of instances when participation in a trial is given as a reason for not providing insurance or insurance being an obstacle to participation in clinical trials, please contact hrapublicinvolvement@nhs.net‘