Research Design Service: East Midlands

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Equality, diversity and inclusion in Patient and Public Involvement and Engagement

  Created on Tuesday, 12 May 2020. Posted in Public Involvement | EDI

As part of NIHR's commitment to actively and openly supporting and promoting equality, diversity, and inclusion (EDI) they've produced new Standard Application Form (SAF) guidance that includes improved requirements to will strengthen EDI and patient, public involvement and engagement (PPIE).

Core outcome set - response to COVID-19

  Created on Friday, 01 May 2020. Posted in Priorities | Methods

Many clinical trials and systematic reviews are already underway, or will begin shortly, to strengthen the evidence base for the COVID-19 response. Core outcome sets (COS), showing the outcomes that should be measured and reported in these studies, will ensure that this evidence base will contain, as a minimum, the key information needed by decision makers about the effects of interventions.

COMET core outcome sets for trials and systematic reviews

COVID-19 Research and Platform (Complex Innovative Design) Trials

  Created on Thursday, 30 Apr 2020. Posted in Methods

A Platform study allows for several experimental treatments to be studied simultaneously. In addition, new experimental treatments can be integrated into an existing study rather than setting up a new study. This allows for more efficient research

Insights into adaptive studies and other complex and novel methods

  Created on Thursday, 30 Apr 2020. Posted in Methods

Research and Development Forum's slides from their Research but not as we know it: Managing novel methods in research symposium (March 2020)

A framework for considering who might be involved in research

  Created on Wednesday, 01 Apr 2020. Posted in Public Involvement

New INVOLVE guidance to be used as a framework to help make decisions about which public contributors you might involve in your research and why.

  • There should always be clarity about the purpose of involving specific individuals or groups
  • Including a diversity of views and perspectives often helps to improve the research
  • Review the way the involvement role and opportunity has been structured to ensure there are not unintended barriers stopping other public contributors from engaging
  • People can wear several hats and their contributions may be broader because of the range of their expertise
  • The type of lived experience needed will vary depending on the focus of the research


UK Government commits £12million to research into preventable diseases

  Created on Tuesday, 17 Mar 2020. Posted in Funding

The UK Government has committed an extra £12million to the National Institute for Health Research in 2020/21 for research into preventable diseases. Heart disease, diabetes, chronic respiratory diseases and cancer are all linked to preventable causes and contribute to slowing improvements in life expectancy, and regional and socio-economic inequalities in health outcomes. This new investment will be directed particularly towards Local Authorities, helping them grow and support their research capabilities so they can work further to solve a range of major preventable health challenges. The aim is that this will support the Government’s work to increase healthy life expectancy by 5 years by 2035, while narrowing the gap between the experience of the richest and poorest.

NIHR develops interactive learning package to support embedding research in the NHS

  Created on Tuesday, 10 Mar 2020. Posted in Toolkit/Database

A new package of interactive learning resources is now available to support research delivery professionals in promoting research to colleagues across the NHS. These resources have been developed to support and inspire research delivery staff in their pledge to embed research in innovative ways across their organisation.

The ‘Engaging with your local NHS’ package sits on NIHR Learn, the NIHR online Learning Management platform, used to deliver its accredited learning programmes. You can access NIHR Learn if you are employed by the NIHR, NHS, a UK university or other publicly funded organisation conducting and supporting clinical research. If your email address ends in one of these pre-approved domains you can self-register for the system. If you do not have an email address from a pre-approved domain your application will be considered for approval.

New funding opportunity seeks to build clinical trials experience for researchers

  Created on Tuesday, 10 Mar 2020. Posted in Funding

Two NIHR funding programmes are joining forces as part of a pilot to provide health researchers the opportunity to undertake a career development award alongside leading an NIHR programme funded clinical study.

For the first time, the Efficacy and Mechanism Evaluation (EME) programme is inviting applications for clinical studies to be led by a chief investigator who is also applying for an NIHR Advanced Fellowship Award. Researchers from across all areas of health are encouraged to apply. The study proposal should evaluate an intervention or medical test with the potential to maintain health, treat disease or improve recovery.

The EME programme is a partnership between the Medical Research Council (MRC) and the NIHR, and both are keen to explore new ways to support the development of capacity and expertise in conducting clinical trials.

Applications to the EME programme are now being accepted and the deadline for these is 16 April 2020. Applications to round four of the Advanced Fellowship scheme will launch at the beginning of April with a deadline for submissions in early June.
Find out more here

HTA remit

  Created on Tuesday, 10 Mar 2020.

The remit for the researcher-led HTA stream hasn't been changed, but now remit and competitive checks now go out to a wider range of people including funding committee chairs and panel chairs and the feedback researchers receive is slightly more helpful and explains why the project isn't in remit.

Remit itself remains as knowing the intervention can work and asking does it work when tested in a national study and is it cost effective for the NHS.

To prove an intervention can work HTA need to see a good signal that it will work if applied across the NHS, usually this evidence will come from a previous small RCT that shows an efficacy signal under ideal circumstances with a health outcome, strong surrogate or meta analysis of an RCT. It's recognised that efficacy for complex interventions can be challenging but the panel still needs a convincing explanation of how the intervention is likely to result in the proposed effect.

It is helpful to have feasibility studies showing that the intervention is acceptable to the population being studied and that randomisation into the study is possible but feasibility is not enough by itself and an efficacy signal will be needed.

HTA evaluates interventions in typical NHS or social care settings with typical NHS or social care users and the panel will need to be convinced that the intervention is ready for such pragmatic evaluation.

The only exception where efficacy signal isn't needed is where an intervention is already widely used in the NHS but evidence of value or harm is lacking. These are usually picked up by the commissioning brief but you can bring one to the researcher-led stream as long as you can demonstrate that decision makers will be responsive to your results.

More information about remit and efficacy can be found on the NIHR website guide 

Top ten tips for developing and using progression criteria for internal pilot studies

  Created on Tuesday, 11 Feb 2020. Posted in Design Tips

From the BMJ Journals: Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies

1. A traffic light system of green (go), amber (amend) and red (stop) might be preferable to a simple stop/go approach when specifying progression criteria for internal pilot studies;

2. Pre-specified progression criteria agreed with funders need to strike a careful balance between being firm enough to promote ambition in the trial team yet being flexible enough to allow opportunities to remedy early problems;

3. Recruitment progression criteria should be based on rates per centre per unit time (eg, per month) that can be easily extrapolated, rather than specifying that an absolute number should be reached by a specific date, due to the unpredictability of opening sites;

4. When recruitment falls behind, it is essential to explore screening logs to determine whether insufficient participants were approached, insufficient participants passed eligibility criteria or insufficient eligible participants agreed to randomisation;

5. The assessment of intervention adherence, cross-over and outcome event rates should take into account the duration from randomisation to timing of primary outcomes if sufficient data are to be gleaned in time to inform progression;

6. When assessing missing data, it is important to explore the degree of missing data within key outcomes as well as the percentage of participants with missing data;

7. Trial teams should involve both their funders and their Trial Steering Committee in assessing their progression criteria;

8. Pilot study recruitment sites should be representative of sites that recruit into the main study;

9. Triallists may be able to take the opportunity to assess whether changes to existing technologies have occurred since the original study was planned, so that new technologies can be considered with funders, such as using an adaptive design;

10. Pilot studies need to be reported fully. An extension to CONSORT guidelines for pilot and feasibility studies is now available.