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Patient Engagement in Clinical Development service: Information Sheet for Life Sciences Organisations


Published: 29 May 2019

Version: 1.0 - June 2019

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Patient Engagement in Clinical Development Service
Information sheet for life sciences organisation
Version 2.0 – 29 July 2019

About the Service

What is the NIHR Patient Engagement in Clinical Development Service?

This animation provides an overview of how the service works (less than 4 minutes). Further detail is provided in the document below.

Involving patients right at the beginning of the clinical development process, at the protocol development stage, has the potential to significantly improve study delivery. As well as providing an opportunity to gain a better understanding of the patient’s needs, it’s also a chance for protocols to be tested, issues to be identified, and problems to be resolved before a study opens for recruitment, which ultimately results in:

  • Better study design
  • Better participant recruitment
  • Better participant retention
  • Better protocol adherence

The primary aim of the service is to bring patients and life science companies together early in the clinical development process, before a study protocol is finalised, so that patients can help companies to optimise the trial design by making it as patient friendly as it can be.

The service is available to all life sciences industries (pharmaceutical, biotech, medtech) including Clinical Research Organisations (CROs).

Secondary objectives of the service include:

  • Supporting the life science industry to navigate and overcome some of the common challenges associated with engaging patient participants in research protocol design.
  • Encouraging and building positive relationships between the life sciences industry, the NIHR and patients.
  • Helping to embed a culture of involving patients right from the start of the clinical development process and throughout the entire life cycle of a study.
  • Providing a national, accessible, standardised mechanism for engaging the public and patients in the trial design stage of the clinical development process.

This service is provided by the NIHR Clinical Research Network. Our vision is to provide a standardised, industry-wide approach to engaging patients earlier in the clinical development process, and instill a culture of partnership working between life science industry organisations, charities and patient groups.

How does it work?

The service is only suitable for studies which are in the early stages of clinical development. To access the service the life science company will provide some essential information about a proposed study or trial and specify the kind of patient engagement activities they require. This is information is submitted using our online registration form. We will then use our national network, which covers the whole of England, to identify* suitable Patient Group(s). Once an interested Patient Group(s) has been identified, we will introduce the Patient Group to the life sciences company to commence discussions and confirm the partnership. We will then continue to support and facilitate the partnership to plan and deliver the required patient engagement activities which might typically include:

  • Approaching potential participants to engage with and be involved in clinical design activities.
  • Identifying research priorities.
  • Commenting upon and co-developing patient information leaflets or other research materials.
  • Reviewing study protocols.
  • Simulating the study delivery approach.
  • Providing patient input on marketing and recruitment materials.
  • Undertaking interviews with research participants/potential participants.

*Our best endeavours will be made to identify suitable patient groups, however we cannot guarantee engagement on behalf of patients.

What are the benefits of utilising the NIHR Patient Engagement in Clinical Development Service?

The NIHR is in a unique position to be able to broker relationships between patients and the life sciences industry. It is a neutral, public sector organisation, which has worked in partnership with the NHS for over a decade and has a long history and track record of supporting the life science industry to deliver clinical research in the NHS. Therefore, this service offers the following benefits:

  • Benefit from our brand – better engagement from charities and patients with trusted brands of the NIHR and the NHS
  • Build better relationships – our role is to broker and develop a relationship on your behalf
  • Achieve equity – guidance on remuneration application for patient involvement activities
  • Bespoke to you – unique support tailor made for your study requirements
  • Continuous support – assistance throughout the whole process

How do I register my study for the NIHR Patient Engagement in Clinical Development service?

To access the service simply complete our online registration form. A member of our team will acknowledge receipt. We will then review the submission and let you know if we need any further information within five business days. Once the service is underway we will liaise with you directly to keep you informed of our progress and to explain our approach for connecting you with the Patient Group(s).

What type of information do I need to provide about myself?

As part of registering your Study for the Patient Engagement Service, we’ll need to collate brief contact details about yourself, this includes:

  • Your name
  • The company you work for
  • The company which is leading the study (usually the same as the company you work for, but not always)
  • Your telephone number
  • Your email address
  • How did you hear about the service?

These contact details are essential for us to deliver the service and you will be asked to agree to us storing your details for this purpose as required by The General Data Protection Regulation 2016/679 (GDPR), see ‘Safeguarding my information’ (below) for more details.

What type of information do I need to provide about the study?

To deliver the service we will need to collate brief details about your study and about the ‘ask’ that will be made of participants, this includes:

    • Description of the study
      If you have a lay summary, it would be useful to include this.

    • Description of the ‘ask’ for individuals participating in the study
      You will need to include all the information that a member of the public will need to enable them to assess and decide if the opportunity is of interest to them. Including
      • what activities you expecting the patients to participate in, for example:
        • review a study protocol
        • review a marketing package
        • simulate a study procedure
        • feedback on a lay summary
        • support an ethics review.
      • Location requirements, number of sessions, length of sessions and any other demands on patient time.
      • What experiences, perspectives, skills or knowledge are desirable.
      • How will you feedback the learnings from the session with participants?
    • What stage is the study at in the research lifecycle
      Consider the stages of research as per NIHR guidance document: Briefing notes for researchers - public involvement in NHS, health and social care research
  • Any study acronyms
  • Sponsor protocol number/reference
    • Whether your study has received ethics approval
      (this is not a prerequisite to register or use the Patient Engagement in Clinical Development Service).
    • If the study has been submitted previously for other NIHR Services
      (e.g. IRAS ID or CPMS ID or REC / Ethics number)
  • Therapeutic area of interest
  • Criteria for patient eligibility participating in the study
    Describe the type of patient the study will be looking for, e.g, specific condition, disease stage such as diagnosis, taking particular medication). Please also include any key exclusion criteria which may prevent a participant from supporting this request.

Safeguarding information

Who will be able to see my contact information and will this be shared?

Once you have registered your study using our online registration form, only approved members of staff based at the NIHR Clinical Research Network will be able to access your information. This includes the Facilitator, and the Head of Business Development and Marketing. Your contact information will be stored in a private Google Sheet hosted on the NIHR HUB.

We will not share your study information initially when searching for a Patient Group(s) matching your request. However, if a suitable Patient Group(s) is identified and expresses an interest in participating, we will seek your consent to share your information with the Patient Group’s main contact for the purpose of fulfilling the service.

Who will be able to see information about the study and will this be shared?

We will share the study information that you have provided via the online registration form with relevant Patient Groups to enable them to understand the ‘ask’ of the request and express their interest. Therefore, please ensure that this information is suitable for the public domain and does not contain any information which your company deems as commercially sensitive. The following information will be shared with Patient Groups:

  • Description of the study
  • Description of the ‘ask’ for patients participating in the study
  • What stage is the study at in the research lifecycle
  • Therapeutic area / target patient population
  • Proposed patient eligibility criteria for participating in the proposed study

If a suitable Patient Group(s) is matched to your request, we will introduce the Patient Group(s) to you and arrange engagement activities to enable two way communication to take place (for example, a focus group, an interview or a workshop). If, during the two way communication between your company and the Patient Group(s), you deem there may be commercially sensitive information shared, then (based on your company policy) you may need to make these arrangements directly with the Patient Group(s) and not via the NIHR Clinical Research Network.

We recommend that you adopt the principles provided by NIHR INVOLVE to ensure individuals feel valued in participating by having a light touch Patient Participation Information Sheet explaining ground rules and principles to adhere to with regards to sharing commercially sensitive information.

Remember, patients are volunteering their time to participate in research and for some it may be the first time they are involved in research in relation to a condition they have been diagnosed with. Therefore we encourage a cooperative approach when collaborating with Patient Groups and participants.

Payment for use of Service

Is this free to register my study?

There is no charge for you to register your study for the service.

At what point will the Clinical Research Network start charging for the use of the Service?

Once you register your study for the service, our facilitator will start working with patient groups and individuals to fulfil your patient engagement request. Following the identification of suitable participants, if you wish to proceed we will provide you a draft ‘Letter of Agreement’.

At this stage you may withdraw your request from the service without charge. However, if you wish to proceed we’ll formalise the details in the Letter of Agreement before proceeding.

If participants have been matched, what is the remuneration package the NIHR Clinical Research Network is offering to individuals for participation and how will I be charged for this?

If participants have been matched to the patient engagement request, we will create a Letter of Agreement which includes all the estimated charges. The costing model is based on:

  • Patient costs, which include remuneration, travel and subsistence. We use the NIHR guidance document: Payment guidance for researchers and professionals to calculate the patient costs.
  • NIHR Clinical Research Network Facilitator costs of identifying the Patient Group, identifying participants and facilitating the patient engagement activities. This is based on a fixed day rate.
  • Consumables - this can include venue hire, catering (as appropriate) and any travel expenses and other consumables.
  • Sustainability charge - this is a percentage charge for the NIHR Clinical Research Network to re-invest in continuing, developing and expanding the service capacity.

The Letter of Agreement has been authored in line with the ABPI and AMRC guidelines and we will work with you to ensure that all compliance and regulatory guidelines are followed.

Withdraw, feedback and complaints

How do I withdraw my registration on the service?

If you would like to withdraw from the Service, please complete this withdrawal request form.

How will questions, complaints and problems be managed?

If you would like to provide feedback or ask a question, please complete this feedback form

Terms of service

Will any information related to this service be published?

Both the NIHR Clinical Research Network and the company may disclose or publish the nature and terms of this agreement for any legitimate purpose, including the disclosure of payments to healthcare professionals and organisations.

How will personal data be managed?

The NIHR Clinical Research Network shall comply with its obligations under the applicable data protection laws. The NIHR Clinical Research Network will not share the personal data of patient participants with the company prior to undertaking the delivery of the request, and then only as required and appropriate with consent provided by the participants (data gathered may include name, address and the nature of any conditions). The company shall process any personal data in accordance with its privacy notice, a copy of which will be requested to be provided to the NIHR Clinical Research Network.

How will anti-bribery and anti-corruption be managed?

Neither the company nor the NIHR Clinical Research Network will, through the operation of this agreement, seek improperly to influence prescribing behaviour, the outcome of clinical trials or any healthcare professional or other government official with the intent to obtain or retain business for the life sciences organisation or for any other improper purpose. If either party breaches this obligation, the other party shall be entitled to end this agreement immediately.