Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to Answer of 8 June 2023 to Question 187791 on Clinical Trials, which phases of clinical trials will GPs to be able to enrol their patients on.
Answered by Neil O'Brien
General practitioners (GPs) play a crucial role in research delivery including the recruitment of participants to clinical research studies. GP involvement in particular trial phases or specific trials can vary based on factors such as trial protocol and the nature of the intervention being tested. GPs typically work closely with research institutions, clinical trial sponsors, and ethics committees to ensure the appropriate recruitment and management of patients in clinical trials.
Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 13 June 2022 to Question 188102 on Yellow Card Scheme, how the Medicines and Healthcare products Regulatory Agency recorded medical device incidents before 2015.
Answered by Will Quince
Prior to 2015, reports of incidents with medical devices were reported on different forms available on the Medicines and Healthcare products Regulatory Agency (MHRA) website. The reports were then automatically loaded and made available for assessment on the Adverse Incident Tracking System, the MHRA’s internal database.
Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many clinical trials were initiated in 2022; and if he will provide a breakdown of those figures by phase.
Answered by Will Quince
A total of 2,101 clinical trials were initiated in England in 2022 which were supported by the NIHR Clinical Research Network.
The following table shows a breakdown of the number and proportion of trials by phase. However, sponsors did not provide information on the phase of trial for just over two-thirds of initiated trials.
Phase | Studies | Percentage |
I | 93 | 4.40% |
I/II | 28 | 1.30% |
I/III | 1 | 0.00% |
II | 244 | 11.60% |
II/III | 13 | 0.60% |
III | 275 | 13.10% |
III/IV | 2 | 0.10% |
IV | 28 | 1.30% |
N/A | 1,417 | 67.40% |
Total | 2,101 | 100.00% |
Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 5 June 2023 to Question 186946, on Yellow Card Scheme, when data collection began on medical devices which will be made available in a format similar to that of the Innovative Devices Access Pathway.
Answered by Will Quince
In 2015, the Medicines and Healthcare products Regulatory Agency (MHRA) simplified its medicine and device incident report systems by extending the Yellow Card scheme to collect reports on medical device incidents in addition to suspected adverse drug reactions (ADRs). The MHRA's interactive Drug Analysis Profiles contain listings of all suspected ADRs reported through the Yellow Card scheme for medicines. MHRA is currently working to improve the Yellow Card reporting site and this work includes enhanced data visualisations of incident reports, and this will be rolled out across all medicinal products, including medical devices. This work will continue through 2023.
Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to his Answer of 5 June 2023 to Question 186944 on Yellow Card Scheme, which international mandatory reporting systems have a (a) better reporting rate and (b) more successful system for detecting safety signals than the United Kingdom, and if he will publish the MHRA review of global approaches to mandatory reporting in other regulatory systems.
Answered by Will Quince
VigiBase is the World Health Organisation's (WHO) global database of reported potential side effects of medicinal products, and in the latest annual report, published by the WHO's Uppsala Monitoring Centre, it shows that the United Kingdom is the third largest contributor of reports, behind the USA and Germany and also one of the highest reporting countries per million inhabitants.
A working group of the International Coalition of Medical Regulatory Authorities prepared a report led by the Medicines and Healthcare products Regulatory Agency (MHRA) which provides an overview of the information provided by the participating regulatory authorities in 2018. The report includes the information collated on mandatory reporting and reporting rates.
Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to help ensure that patients living with incontinence are (a) able to access a sufficient number of products to meet their clinical needs and (b) not constrained by a limit on supply.
Answered by Will Quince
Continence care needs may be managed by individuals in a range of ways. Products can be bought from supermarkets, pharmacies or mail order and are available on prescription under the National Health Service. For a continence product to be able to be prescribed, it must be listed on ‘Part IX’ of the Drug Tariff.
There are over 3,000 listed continence products on Part IX available to be prescribed. Of these, over 1,700 are catheters. On application to Part IX, an assessment of products is made to check they are safe and of good quality, are appropriate for prescribing and are cost-effective. These products can all be prescribed where the clinician is assured that the clinical condition warrants a prescription.
We are not aware of any current supply disruptions and the Department works closely with the Devolved Administrations, NHS England, NHS Supply Chain, and suppliers to maintain continuity of supply across a broad range of products to minimise the impact of any potential supply disruptions on patient care. The Department proactively monitors supply conditions and engages extensively with industry to proactively identify potential threats to the supply of medical equipment.
Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 13 December 2022 to Question 103061 on Surgical Mesh Implants, whether the peer review of the audit has been completed; and if he will publish the final decision of the review.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The retrospective audit of mesh procedures has been completed and will be published in due course.
Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, on how many occasions a Marketing Authorisation Holder of a pharmaceutical product has notified (a) the National Homecare Medicines Committee and (b) individual clinical referring centres of a decline in homecare medicines services to a level that could be considered a risk to patient safety in each of the last five years; and if he will make a statement.
Answered by Will Quince
NHS England’s four national frameworks for Homecare Medicine Services do not have a direct contractual relationship with the Marketing Authorisation Holder; the relationship is directly with the homecare provider. Therefore, this information is not available, and is not held by the National Homecare Medicines Committee or NHS England.
Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of (a) the reasons for trends in the level of patients participating in clinical trials in England since 2018 and (b) the impact of financial incentives to GPs to enrol patients in clinical trials on levels of participation; whether he has had discussions with the (i) British Medical Association and (ii) Royal College of General Practitioners on this matter; how the amount paid per patient enrolled onto a clinical trial will be calculated; and whether measures will be put in place to ensure (A) patients (1) are able to give and (2) have given fully informed consent and (B) vulnerable patients are protected.
Answered by Will Quince
Overall, there has been an increase in the number of participants recruited to clinical studies in England since 2018. During the COVID-19 pandemic, recruitment to studies on the National Institute for Health and Care Research (NIHR) Clinical Research Network (CRN) Portfolio increased by 90% to an average of over 115,000 participants recruited per month in 2020/21. During the pandemic, many non-COVID studies were paused to focus on nationally prioritised COVID-19 studies. The Department, working in partnership with NHS England, has taken action to recover the UK’s capacity to deliver research through the Research Reset programme. By May 2023, a rolling average of over 77,000 people were recruited to studies on the NIHR CRN portfolio, 10,000 more than the monthly average prior to the pandemic in 2019/20.
In February 2023, the Government commissioned an independent review to offer recommendations on how to resolve key challenges in conducting commercial clinical trials in the UK and transform the UK commercial clinical trial environment. The Lord O’Shaughnessy Review, published in May 2023, highlights the opportunities for primary care to deliver population-scale trials. A comprehensive response will be published in the autumn covering decisions on the recommendations not covered in our first step, including financial incentives for general practitioners (GPs) to take part in commercial trials. We will seek input from stakeholders as we make our assessment.
Payments to GPs for involvement in clinical research delivery are based on standardised costing methodologies supported by NHS England and NIHR CRN to provide transparency and reassurance that there are not undue incentives to GPs or other health professionals, or inappropriate personal financial gain.
All clinical trials are reviewed by a Research Ethics Committee (REC) prior to the research starting. All RECs in the UK are recognised as meeting the standards set out in legislation. RECs consider the method of seeking consent and the information that is provided to potential participants, including those that may be vulnerable, to ensure that they are appropriately informed and able to make a choice about participation.
Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, which body has responsibility for analysing data collected by the Adverse Events Yellow Card system; and what assessment has he made of the potential merits of collating this data on a publicly accessible database.
Answered by Will Quince
The Medicines and Healthcare products Regulatory Agency (MHRA) collects and analyses the data received through the Yellow Card Scheme, and publishes data on medicines and COVID-19 vaccines in a searchable database on the Yellow Card website for transparency purposes.
As outlined in the Yellow Card Privacy Policy, the MHRA has responsibilities under both the UK General Data Protection Regulation and the Data Protection Act 2018 to protect confidential data and personal data pertaining to individuals. The content and format of the data is currently being enhanced in line with patient and healthcare professional feedback and will be expanded to include medical devices in due course. The data provided will continue to be aligned to the MHRA’s legal responsibilities to data subjects.