Patient Engagement in Clinical Development service: Information Sheet for Life Sciences Organisations
Patient Engagement in Clinical Development Service
INFORMATION SHEET FOR LIFE SCIENCES ORGANISATION
Version 1.0 – 02 October 2018
About the Service
What is the Patient Engagement Service?
The NIHR Clinical Research Network launched the Patient Engagement Service in October 2018 with the purpose of introducing and facilitating partnerships between Life Sciences Organisations (such as Pharmaceutical, biotech, medtech, CRO companies) and Patient Groups for Studies which are in the early stages of clinical development.
The approach is that the NIHR Clinical Research Network - where possible - will identify and introduce the relevant Patient Group to the Life Sciences Organisations and then facilitate the remit of clinical development. This typically involves partnering Life Sciences Organisations and Patient Groups in order to:
- Identify research priorities
- Commenting and developing patient information leaflets or other research materials
- Review study protocols
- Simulate study delivery approach
- Feeding back on marketing and recruitment materials
- Undertaking interviews with research participants
The Clinical Research Network has launched this Service with the simple aim of:
- Ensuring better study protocol design which could lead to better study delivery
- Encouraging and building positive relationships between Life Sciences, the NIHR and patients;
- Providing opportunity for study protocols to be reviewed and tested by patients to identify issues before a study is open to recruitment at site level
What are the benefits of utilising the Patient Engagement Service?
Better study design often leads to better study delivery in particular achieving recruitment to time and target. By involving Patients from the start of the clinical development, you can ensure Patients are involved right the way through the decision making process.
How will the Clinical Research Network introduce and facilitate working with Patient Groups?
The way it works is very similar to other NIHR Services, whereby, the NIHR Clinical Research Network using a network of Organisations to identify, introduce and facilitate the partnership between Life Sciences Organisations and Patient Groups for Studies which are in the early stages of clinical development. In brief, you’ll complete a registration form which will allow the NIHR Clinical Research Network then to reach out and identify Patient Groups which fit the remit of the ‘ask’. Once found, the NIHR Clinical Research Network will then support with partnering you with the Patient Group, such as managing arrangements for a focus group, a workshop or a simulation exercise.
How to register for the Service
How do I register the Study for the Patient Engagement Service?
If you would like to register your study for the Patient Engagement Service, then please complete a brief registration form. A member of the NIHR Clinical Research Network will review the information and firstly acknowledge receipt and then provide feedback on approach we will take for introducing and facilitating a meeting with a Patient Group. The acknowledgement of receipt of the registration will occur within 5 business days.
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 but not always)
- Your telephone number
- Your email address
- How did you hear about the Service
The purpose of collating your contact details is just so that a member of the NIHR Clinical Research Network can be in touch and discuss the approach we will take for introducing and facilitating a meeting with a Patient Group.
What type of information do I need to provide about the Study?
As part of registering your Study for the Patient Engagement Service, we’ll need to collate brief details about the Study and about the ‘ask’ of being introduced to Patient Group, this includes:
- Description of the study - if you have a lay summary, it would be useful to include this.
- Description of the ‘ask’ of Patient Groups participating in the study - (What is expected of the patients, for example, to review a study protocol, review a marketing package, simulate in a study, feedback on a lay summary, support in ethics review, any requirements for location, any requirements for number of visits, amount of time any other demands on patient participation). You will need to include all the information that a member of the public would need to identify if this is an opportunity that would be of interest to them, such as what experiences, perspectives, skills or knowledge will be required of patients who be involved in the study? How will patients getting involved in the study benefit?
- What stage is the study at in the research lifecycle? Consider the stages of research as per NIHR INVOLVE guidelines (page 25)
- Any study acronyms
- Sponsor protocol number/reference
- Whether your study has received ethics approval - note, this is not a prerequisite to register or use the Patient Engagement in Clinical Development Service.
- Where the study has been submitted previously for other NIHR Services (e.g. IRAS ID or CPMS ID or REC / Ethics number)
- Therapeutic / Target Patient Group Area
- Criteria for Patient eligibility participating in the study (describe the type of Patient the study is looking for, for example, diagnosis, taking particular medicines and also describe the type of participants that cannot take part such as very specific exclusions criteria).
The purpose of collating details about the Study and the ‘ask’ is just so that we can identify relevant Patient Groups and facilitate the introduction within the remit of your request.
Who will be able to see my information and will this be shared?
Once you have registered the Study via the form, only approved members of staff based at the NIHR Clinical Research Network will be able to access your information. This includes the Facilitator, the Head of Business Development and Marketing and the Stakeholder Engagement Manager at the NIHR Clinical Research Network. Your information will be stored in a private Google Sheet hosted on the NIHR HUB.
The NIHR Clinical Research Network will not share your information when the CRN reaches out initially to Patient Groups to identify that the level of interest matches against the ‘ask’ of the Study.
However, in the event a suitable Patient Group is identified and has expressed an interest in participating, then the NIHR Clinical Research Network at this point will seek your consent to share your information with the Patient Group facilitator for the purpose of fulfilling the remit of the ‘ask’.
Who will be able to see information about the Study and will this be shared?
Once you have registered the Study via the form, only approved members of staff based at the NIHR Clinical Research Network will be able to access information about the Study. This includes the Facilitator, the Head of Business Development and Marketing and the Stakeholder Engagement Manager at the NIHR Clinical Research Network.
The information about the Study will be stored in a private Google Sheet hosted on the NIHR HUB.
The NIHR Clinical Research Network will share the Study information that you have provided as part of reaching out to Patient Groups to identify the level of interest to match against the ‘ask’ of the Study. The information which you provide through the registration form will be shared with Patient Groups, therefore, please do 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 you provide on the registration form will be shared with Patient Groups:
- Description of the study
- Description of the ‘ask’ of Patient Groups participating in the study
- What stage is the study at in the research lifecycle
- Therapeutic / Target Patient Group Area
- Criteria for Patient eligibility participating in the study
In the event a suitable Patient Group is matched to the remit of the ‘ask’, the NIHR Clinical Research Network will facilitate the introduction to the Patient Group and set up any arrangements for two way communication to take place (for example, a focus group, an interview or a workshop).
In the event during the two way communication between your company and the Patient Group 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 Groups (and not with the CRN). It is recommended to take on board the principles provided by NIHR INVOLVE to ensure Patients feel valued in participating by having a Patient Participation Information Sheet just explaining ground rules and principles to adhere to with regards to if any commercially sensitive information is shared.
Remember, Patients are volunteering their time to participate in research and for some it may be the first time they are involved in research due to a condition they have been diagnosed with, therefore, we’d like to encourage a cooperative approach when collaborating with Patient Groups and a focus on the principles of two way involvement.
Payment for use of Service
Is this free to register?
Yes! There is no charge for you to register your Study for the Patient Engagement Service.
At what point will the Clinical Research Network start charging for use of the Service
Once you register your study for the Patient Engagement Service, the NIHR Clinical Research Network facilitator will start a new timesheet to record the effort taken in identifying and introducing you to a Patient Group. In the event you wish to proceed following the identification of a Patient Group, then we’ll provide you with a quotation of the effort to date under what is called ‘Letter of Agreement’. It is entirely your choice if you wish to withdraw your study from the Patient Engagement Service at that stage and there will be no charge for this. However, if you wish to then request the NIHR Clinical Research Network to introduce you to Patient Group and facilitate the remit of the ‘ask’, then we’ll agree the costings and formalise in a Letter of Agreement prior to proceeding.
If a Patient Group has been matched, then what is the remuneration package the NIHR Clinical Research Network is offering to Patient Groups for participation and how will I be charged for this?
If a Patient Group has been matched to the remit of the Study, then the CRN will draw up a Letter of Agreement which includes a quotation of the charges. The costing model is based on:
- Patient costs, which include remuneration, travel and subsistence. We use the NIHR INVOLVE guidelines to calculate the Patient costs
- NIHR Clinical Research Network Facilitator costs of identifying the Patient Group, introducing the Patient Group to you and then facilitating the remit of the ‘ask’. This is based on a fixed day rate and you will receive a copy of the timesheets for reference
- Consumables - this can include venue hire, catering (as appropriate) and any travel expenses and consumables
- Sustainability charge - this is a percentage charge for the NIHR Clinical Research Network to re-invest in developing the offerings of the Service
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 Form.
How will questions, complaints and problems be managed?
If you would like to provide feedback or raise questions, please complete this 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 the patients with the company, only the named individual who is nominated as the lead facilitator at the company. The company shall process any personal data in accordance with its privacy notice.
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