Enhancing access to clinical trials for consented volunteers

MAC Clinical Research Finance Ltd requires access to NHS England Data for the purpose of providing services to clients in the health sector.

MAC Clinical Research Finance Ltd is a trading arm of parent company MAC Research Ltd. MAC Research Ltd is a Contract Research Organisation (CRO) dedicated to accelerating clinical trials to develop new and improved treatments for patients.

Members of the UK public engage MAC Clinical Research Finance Ltd to register onto MAC Clinical Research Finance Ltd’s Volunteer Database. MAC Clinical Research Finance Ltd will access NHSE Data for screening of volunteers for eligibility to be invited onto a specific clinical trial based upon the trial sponsor criteria for eligibility. Volunteers give informed consent for MAC Clinical Research Finance Ltd to access their health data for this purpose, or consent is provided on their behalf by a parent or legal representative ('consultee').

Volunteers give informed consent at up to three stages throughout a journey to participate in a clinical trial. The scope of this Data Sharing Agreement is the 'Consent to disclose' phase only:

1. Consent to disclose – this is where an individual will consent to their personal identifiers being sent to NHS England to link and obtain medical history. This consent process is within the scope of this Data Sharing Agreement.

2. Consent to screen – this is where an individual will consent to screening for a specific trial and provide their personal information directly to MAC Clinical Research Finance Ltd. This is NOT within the scope of this Data Sharing Agreement.

3. Consent to trial – this is where the individual (if deemed eligible) will consent to participate in a specific trial. This is NOT within the scope of this Data Sharing Agreement.

The objective for processing is to improve the quality and efficiency in matching volunteers in the MAC Clinical Research Finance Ltd Envision volunteer database to suitable clinical trials, supporting UK volunteers to access suitable clinical trials whilst maintaining volunteer safety and wellbeing by ensuring that assessments are based on comprehensive healthcare information.

The Data will be used to provide services to the following types of clients only:

• Life science industry (biosciences)

• Pharmaceutical companies

• Medical Device companies

• NHS Trusts

• Mental Health Trusts

• Universities

Approximately 95% of MAC Clinical Research Finance Ltd clients are pharmaceutical, medical device, or bioscience companies. Approximately 5% of MAC Clinical Research Finance Ltd clients are NHS Trusts or Universities.

The Data will be used to provide the following service only:

• Recruitment onto clinical trials

The following NHS England Data will be accessed:

• Hospital Episode Statistics

o Admitted Patient Care

o Accident & Emergency

o Outpatients

• Emergency Care Data Set (ECDS)

Access to these Data is required to match volunteers to suitable clinical trials with more speed and accuracy for the following reasons:

• Current timelines for obtaining healthcare screening information via General Practitioners ('GPs'), currently takes between 6-12 weeks. This means that many volunteers who would like to participate in a clinical trial are unable to do so. This is either because the trial has finished recruiting before this information is received, or the volunteer cannot continue to wait until their medical records arrive. This is particularly important to Patient Volunteers who have serious and debilitating conditions and may directly benefit from participating in a clinical trial. Access to the volunteers' electronic HES/ECDS data will enable MAC Clinical Research Finance Ltd to more rapidly receive this information and will reduce the administrative demands placed on GPs.

• The quality and format of HES data will also help MAC Clinical Research Finance Ltd to ensure that health factors which may make taking part in a clinical trial unsafe for the volunteer are identified, therefore protecting their safety and wellbeing. Whereas GP records contain written letters and summaries of secondary care diagnoses and treatments, the standardised and coded HES data can be easily screened for key eligibility factors, reducing the risk of missing key information. The HES data are longitudinal, and contain information about relevant details which the volunteer may have forgotten and which may not be captured in sufficient detail in GP records. The coded and pseudonymised format of the data, and the sharing of it via secure electronic transfer, will also enhance data privacy when accessing this information, compared with GPs posting or emailing copies of identifiable written records.

• The broader public benefits of this processing include reducing the administrative delays which extend the time to evaluate new treatments before they can be safely introduced to the health system. The use of the HES data will improve efficiency in clinical trials and also help to reduce the cost of clinical trials in the UK. This is key to encouraging more inward investment in the development of new medicines and other treatments in the UK, allowing more UK volunteers to participate in suitable clinical trials.

The level of the Data will be Identifiable.

Pseudonymised data flowing from NHS England to MAC Clinical Research Finance Ltd will include a unique ID to enable linkage to volunteer data collected and held by MAC Clinical Research Finance Ltd in the Envision Volunteer Database.

MAC Clinical Research Finance Ltd will access the HES/ECDS data to verify and confirm the medical history information provided directly by the volunteer and use this to assess volunteer suitability to participate in current and/or future clinical trials.

The Data will be minimised as follows:

• Limited to a cohort identified by MAC Clinical Research Finance Ltd.

• Limited to data from 2010 onwards.

The Data supplied by NHSE will be used exclusively for the purpose of assessing volunteer suitability for invitation to clinical trial(s). The Data will not be shared with the organisations commissioning MAC Clinical Research Finance Ltd services or any other organisation. All other processing related to clinical trial participation are subject to further clinical trial consent processes, during which implications for the processing of volunteer data is provided to the participant to inform their decision on whether they wish to participate.

MAC Clinical Research Finance Ltd stores volunteer personal information for up to 6 years from the point of consent unless volunteers provide consent for MAC Clinical Research Finance Ltd to keep their personal information for longer periods. For example, if a volunteer gives further consent at the ‘Consent for screening’ phase for participation in a clinical trial, regardless of whether they go on to participate in the trial, their personal information will be retained for a longer period, which may be more than 25 years after the trial has completed.

MAC Clinical Research Finance Ltd is the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party.

MAC Clinical Research Finance Ltd has determined the processing is necessary for its legitimate interests in being able to provide tools and services that will benefit healthcare organisations.

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

Microsoft Limited provides IT back up services to MAC Clinical Research Finance Ltd and will store copies of the Data as contracted by MAC Clinical Research Finance Ltd.

Data will be accessed by:

• Substantive employees of MAC Clinical Research Finance Ltd.

• Independent Specialist Contractors employed by MAC Clinical Research Finance Ltd.

• Agency workers engaged by MAC Clinical Research Finance Ltd through consultancy agreements (e.g. locum medical consultants) for the purposes of assessing volunteer eligibility for recruitment to a clinical trial.

MAC Clinical Research Finance Ltd provides clinical trial recruitment services to volunteers and clinical trial sponsors.

The funding arrangements for these services are as follows:

• Volunteers:

The cost of onboarding volunteers and matching them to potentially suitable trials, are borne by MAC Clinical Research Finance Ltd as an operating cost.

• Trial Sponsors:

MAC Clinical Research Finance Ltd identifies potentially suitable volunteers from the volunteer database and approaches them to discuss each suitable clinical trial. If the volunteer consents to take part in the trial, MAC Clinical Research Finance Ltd receives funding from the Trial Sponsor.

Trial Sponsors include commercial organisations from the pharmaceutical and biotechnology industry, and non-commercial organisations including the NHS, universities, and Government agencies, such as UKHSA. At present, 95% of MAC Clinical Research Finance Ltd’s sponsors are commercial companies and 5% non-commercial. MAC Clinical Research Finance Ltd is expanding its non-commercial portfolio and this percentage is expected to increase over the coming years as Clinical Research Finance Ltd continue to develop partnerships with non-commercial sponsors and more non-commercial sponsors look to commercial CRO’s to support them to address NHS capacity barriers to delivering vital clinical research.

MAC Clinical Research Finance Ltd does not trade or sell personal information.

While there are commercial interests for MAC Clinical Research Finance Ltd, and Trial Sponsors in processing this data, these are proportionately balance with the potential benefits to the volunteer, GPs and the wider health and social care system in England and Wales through the provision of health care and the promotion of health.

Examples of client trials/studies already facilitated by MAC Clinical Research Finance Ltd’s function as a CRO include:

Following the Covid-19 pandemic and MAC Clinical Research Finance Ltds involvement in the delivery of the UKHSA Test and Trace programme, MAC Clinical Research Finance Ltd have developed well established relationships with the National Institute for Health and Care Research, Patient Recruitment Centres (PRCs), and the wider Clinical Research Networks, many of which have supported as Patient Identification Centres for research studies conducted at MAC Clinical Research Finance Ltd. Examples of such studies include working with Blackpool and Manchester hospitals to deliver research supporting participants living with severe COPD. Another example is a recent collaboration with Sheffield Teaching Hospitals to offer clinical trial opportunities and alternate treatment options to participants newly diagnosed with Idiopathic Pulmonary Fibrosis.

MAC Clinical Research Finance Ltd will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode, Name, and a unique person ID) for the cohort to be linked with NHS England data.

MAC Clinical Research Finance Ltd will flow identifiers to NHS England on a monthly basis for participants who are undergoing eligibility screening for actively recruiting clinical trials for which MAC is a CRO. MAC expects to flow identifiers for ∼5,000 volunteers per month.

NHS England will provide the relevant records from the HES and ECDS datasets to MAC Clinical Research Finance Ltd. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by MAC Clinical Research Finance Ltd.

MAC Clinical Research will securely destroy NHSE Data in circumstances where a volunteer withdraws consent for trial eligibility screening in the time-period between the volunteers personal identifiers flowing to NHSE for linkage, up to the point of consent for participation in trial specific screening. If a participant withdraws consent for eligibility screening AFTER consenting to trial specific screening, the volunteer will be removed from the Envision database, but their Data will be kept for 15-years or longer, in line with MHRA data retention guidance for clinical trial screening.

The Data will not be transferred to any other location.

The Data will be stored in MAC Clinical Research Finance Ltd’s Envision database on servers at MAC Clinical Research Finance Ltd.

MAC Clinical Research Finance Ltd stores Data on the Cloud provided by Microsoft Limited.

The Data will be accessed onsite at the premises of MAC Clinical Research Finance Ltd and will also be accessed by authorised personnel via remote access.

The Controller must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

• Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

• Access controls granting users the minimum level of access required are in place;

• Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

• Multifactor authentication (MFA) is required for remote access;

• Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

• All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

The Data will not leave the UK.

Access is restricted to substantive employees or MAC Clinical Research Finance Limited and Independent Specialist Contractors employed by MAC.

Organisations under contract with MAC Clinical Research Finance Ltd are not permitted to access the Data.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will be linked at person record level with volunteer data held in the Envision volunteer database on MAC Clinical Research Finance Ltd servers.

Employees or Independent Specialist Contractors from MAC Clinical Research Finance Ltd will process the Data for the purposes described above.

The output of this processing is the efficient and accurate assessment of volunteers suitability to take part in a clinical trial.

When a trial is completed, the results of the trial are published online, including any subsequent findings, in an open access clinical trial registry, ensuring outputs are disseminated to a global audience.

Where the trial is intended to support a marketing authorisation, a dossier of evidence, including the trial report, is submitted to the regulator. Most trials are normally completed within 12-24 months. However, the publication of trial results and marketing authorisation submission to the MHRA typically takes between 2 and 5 years after an early phase trial is completed as the drug must pass through subsequent phase III trials first in larger populations.

Trial outcomes are also disseminated (including aggregated data) via a variety of public and professional channels including National Institute for Clinical Excellence reports, peer-reviewed journals, workshops, webinars, websites, newsletters, open lectures, talks, exhibitions at public events, briefing documents, posters, press/media engagements, stakeholder mailing lists, social media, public reports, direct bilateral public and professional engagement using new and established relationships, co-hosted events, open-source frameworks, etc.

The services provided to clients are expected to identify improvement opportunities which clients may then exploit by making changes to systems, processes, resources or infrastructure to improve patient experience and patient care.

Depending upon trial outcomes, clients such as pharmaceutical and medical device companies may introduce novel drugs or devices that could improve patient care. It should be noted that clients may also choose not to introduce novel drugs or device innovations to the market.

The direct and indirect benefits of this processing to the following parties will be:

1. Volunteers

The direct benefits for consented volunteers which will arise from this processing include, increased safety and efficiency in the assessment of their eligibility to participate in clinical trials, and enhanced data security procedures for accessing medical history data. This increases opportunities for volunteers to participate in suitable clinical trials and for patient volunteers to receive innovative new therapies, which may lead to improved clinical outcomes for them. It is expected that this processing will shorten the average time taken to obtain medical records by up to 12 weeks per volunteer. The impact of the processing of this data will be evidenced by a reduction in the average time taken to obtain medical records for volunteers, and a shorter average eligibility assessment period. Currently the average eligibility assessment period is 12 weeks and 20% of the records requested are not received from GPs within the trial recruitment window. We would expect to start seeing the positive impacts of this processing on these metrics within the first year.

The longitudinal, structured, and coded format of the data will ensure that the required information can be accurately assessed and that only the information needed for these purposes is processed. Data security arrangements afforded via the DARS process ensure that healthcare information is pseudonymised and shared via Secure Electronic File Transfer, or the DAE which further reduces the risk of identifiable personal information breaches.

In a recent survey of volunteers, 97% of respondents said that they would prefer for MAC Clinical Research Finance Ltd to receive their healthcare data digitally via NHS England as opposed to paper copies from their GP practice. This clear consensus indicates that this approach would we welcomed by the vast majority of volunteers and would not significantly deter volunteers from taking part in clinical trials.

2. General Practitioners

Currently MAC Clinical Research Finance Ltd requests medical history data from the volunteers GP. This process often takes between 6-12 weeks, as GPs are extremely busy they do not always have the ability to provide a timely response. In a recent survey of GPs from whom MAC Clinical Research Finance Ltd regularly request records, 68% responded that it takes them more than 15 minutes to compile and dispatch a single medical record. With MAC Clinical Research Finance Ltd currently requesting approximately 5,000 medical records per month, this represents an estimated 15,000 hours of GP administration time per year. The yielded benefits to GPs will be a significant reduction in the amount of administration associated with MAC Clinical Research Finance Ltd trials. It is expected that the volume of requests which need to still be submitted to GPs' annually by MAC Clinical Research Finance Ltd will reduce by 75-85% (subject to the quality and completeness of HES data provided). Alleviating this administrative requirement from GPs will reduce pressure on these vital resources and ensure that this resource is instead focussed upon other patient care activities.

3. Trial Sponsors

The most common reason for delays in completing clinical trials is the inability to recruit suitable participants during the planned recruitment period. This is in part due to the time taken to obtain the relevant medical information needed to assess the participants eligibility. The current process for obtaining this information often adds months or even years of unnecessary delays to clinical trial timelines. Therefore, these delays impact the time taken to demonstrate the safety and efficacy of new therapies and ultimately introduce them into global health systems. Reducing the unnecessary delays associated with participant recruitment is vital to reducing delays in the development and introduction of new treatments. These delays significantly increase the cost of the development of these products to sponsors and deter commercial investment from the biopharmaceutical industry in UK clinical trials. It is expected that these delays will also reduce by 50% (subject to the quality and completeness of HES data provided).

4. MAC Clinical Research Finance Ltd

The fees currently paid to GPs to compensate them for their time and inconvenience will be repurposed to fund the DARS fees and, as such, are not expected to result in a cost saving benefit for MAC Clinical Research Finance Ltd. However, the labour efficiencies generated within MAC Clinical Research Finance Ltd will be repurposed to delivering high quality clinical research services to volunteers and trial participants throughout their engagement with us and delivering high quality clinical trial evidence to Trial Sponsors. MAC Clinical Research Finance Ltd will also benefit by being able to provide more expedient and high quality trial participant recruitment services to both volunteers and sponsors. This expedited participant recruitment performance may result in the indirect benefit to MAC Clinical Research Finance Ltd through increased business development opportunities. However, this is balanced by the operating cost of delivering services to volunteers, many of whom may not be matched with a suitable trial or may decline trial participation. MAC Clinical Research Finance Ltd maintains metrics of the proportion of its trials which are delivered on time and with the target number of participants. It is expected that there will be a 10% improvement in these metrics through the processing of the HES data (subject to the quality and completeness of HES data provided). The expected significant reduction in the volume of paper medical records which will copied and couriered by Volunteers GPs will benefit MAC Clinical Research Finance Ltd in meeting its commitment to reducing greenhouse gas emissions. MAC Clinical Research Finance Ltd is committed to reducing its scope 1 and 2 GHG emissions by 42% by 2030, and to measuring and reducing its scope 3 emissions. The targets are verified, assessed, and reported annually. MAC Clinical Research Finance Ltd's Corporate Social Responsibility ('CSR') 2023 report can be viewed at: https://www.macplc.com/2023-csr-annual-report/

5. Wider public benefits

There is also an indirect benefit to the general public and to health and social care in England and Wales from harnessing our unique national digital assets to expedite clinical trial completion and introduce new innovations into the NHS. It may take several years to observe the impact of this processing on the UKs market share position in clinical trial investment. This will also be influenced by a multitude of measures which are being developed across the UK and by the UK government in order to enhance the UKs desirability as a global clinical trial destination. As such, there are no proposed metrics for measuring the benefit of this processing. We acknowledge that trials have outcomes and that investigational treatments and/or innovations may not be released to the market. There are wider health benefits of clinical research trials irrespective of the success or failure of the trial, as information and results contribute to the generation of knowledge guiding further research and the prevention of ineffective and harmful products reaching the market.

Safety monitoring continues beyond the trial in accordance with applicable regulatory requirements.

Specific example of potential benefit to volunteers:

A specific example of this benefit to volunteers, is the ability to assess eligibility and enter patient volunteers into a clinical trial at the time when treatment is needed. Whether this be early in the onset of a new condition, or during a period of heightened symptoms of a chronic condition. An example of this is seen in a recent Ulcerative Colitis trial which MAC Clinical Research Finance Ltd has delivered. This chronic condition causes patients to have extended periods of remission followed by short periods, lasting from a few days to a few weeks, where the symptoms are particularly troublesome and significantly impact their everyday life (flare-ups). The trial sought to explore the efficacy of a new treatment for ulcerative colitis which aims to relieve symptoms during a flare-up and prevent symptoms from returning. To be eligible for the trial, patients needed to be identified, screened, recruited, and receive the trial treatment during a flare-up.

Under the current processes for obtaining medical history screening data from GP’s often takes between 6-12 weeks. During this period volunteers are unable to access to the trial intervention and often must resort to alternative treatment options and/or their condition has either improved or deteriorated, making them unsuitable for the trial. This delay therefore prevents volunteers from participating in the trial that may have offered improved treatment outcomes, and significantly delays the development of better treatment options for all ulcerative colitis patients.

Yielded Benefits is not a requirement for new applications.