Frequently asked questions
GLOSSARY
Design of clinical trials
This makes reference to the engagement/ involvement of patients in different aspects of a clinical trial as for example contributing to the design of the protocol of clinical trials, discussing the potential burden that the people who will participate in the trial may experience, discussing the outcomes of the trial which could be more important to patients.
Early discussions with regulators and Health Technology Assessment bodies
This makes reference to the engagement / involvement of patients in early scientific discussions that can take place between industry, HTA agencies and regulators (and in some cases also with payers) to discuss developmental plans for a medicinal product and to ensure these plans meet the requirements.
Patient engagement (PE)
We define patient engagement as the effective and active collaboration of patients, patient advocates, patient representatives and/or carers in the processes and decisions within the medicines lifecycle, along with all other relevant stakeholders when appropriate.
Payer
Insurer or other organisation paying for healthcare
Research funder
Research funder is any organisation or institution that funds research.
Research priority setting
This makes reference to the engagement / involvement of patients in setting priorities for research and could involve for example providing opinion, providing evidence and/or being part of a group that decides what is important to research.
TAKING THE SURVEY
Who should take the survey?
We welcome responses from the all stakeholder with experience in patient engagement in the process of developing medicines. Several questions in the survey are about different aspects of your experience of taking part in a patient engagement activity in the process of developing medicines (i.e. being involved in setting priorities for research, in the design of clinical trials or in early dialogues with regulators and HTAs). If you have never been engaged in a patient engagement activity in one or more of these three areas you may still be able to complete some of the questions but you may find it a bit more difficult.
Are companies supposed to respond as one single response, or should different company representatives respond individually?
Companies may respond either way, though company representatives could also respond choosing the stakeholder group they belong to (i.e. pharmaceutical representatives could choose pharma, or HCP, or other depending which hat they are wearing). Responding individually will give us more granular responses of your expectations and needs, but it is also ok to group the response to one that represents the whole company.
How can I change the language of the survey?
See the top right corner and choose your preferred language. The survey is provided in all EU languages.
Can I stop midway and continue later?
Yes you can. There is a link on the top of each page to “Save and continue later”. The system will ask you to provide your email address and you will receive a link that will allow you to continue at a later time.
When does the survey close?
The survey closes end of July (July 31, 2018).
SPECIFIC SURVEY QUESTIONS
Survey question 2: Where are you located?
If you are taking the survey as an individual, please tell us where you reside. If you are affiliated to an organisation, then answer from the perspective of that organisation.
Survey question 3: In your patient engagement activities, how have you been involved with each of these stakeholders for each phase of medicines development?
- With this question we want to know from your perspective, if you’ve had and how have you (or your organisation) been involved with each stakeholder, and in which of the three points in medicines research and development.
- You may find it easier to complete this table if you start thinking about the columns. For example, start with column 1, have you been involved in setting priorities for research (“research priority setting”)?
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- If so, look now at the different possibilities in the rows. In the rows there is a list of possible stakeholders (e.g. academia, policymakers and regulators, funders of research etc) with whom you may have collaborated with for setting priorities of research.
- For each stakeholder with whom you were involved for setting priorities for research, then think about your role in this and tick the appropriate answer (i.e. deciding, consulting, informing). In the online survey you can find an explanation of what we mean by each of these three roles.
- Complete only the rows of stakeholders who were involved in setting priorities for research.
- If you have never been engaged/ involved in setting priorities for research, then leave this column blank and complete the second column.
- Repeat the same process for column 2 (design of clinical trials) and 3 (early dialogues).
Survey question 4: From the list of challenges below, with which stakeholders did you experience the following challenges?
This question refers to the challenges that you may have encountered when participating in a patient engagement activity in the process of developing medicines. Please think about the stakeholders with whom you have been involved / engaged and for each of them, tick the challenges that you experienced (if any).
- For stakeholder with whom you were involved but with whom you did not experience any challenges, don’t tick any options
- If you did not experience the challenges listed, please skip that row.
Survey question 6: What is your impression of how current patient engagement compares to ideal patient engagement at these different stages of medicines research? (0-100 distribution scale; 100 = ideal, 0 = none)
With this question we are asking for your personal perspective and we want to know how you would envision ideal engagement and how does that vision fit with your perception of how patient engagement is at the moment. What is your perception of current PE vs what would you think would be ideal – is the current situation anywhere near the vision? If you don’t know how to answer, click on the sliding ball on the grid at 0 and do not slide it at all.
Please note that this same question is repeated considering different times/ stages during the process of developing medicines. (e.g. priority setting, early dialogues, licensing etc)
Specific section for Patients and carers, Patient advocates, Patient Organisation
Survey Question: How prepared is your organisation to actively participate in patient engagement in terms of…
Please answer this question if you belong to or are part of a patient organisation or similar organisation and you take part in patient engagement activities as a member of this organisation. If you are not part of any organisation as a patient, please go to the next question.
- Internal processes: this refers to the different actions or steps taken by the organisation in order to achieve patient engagement.
- Knowledge (information and expertise): this refers to whether the organization has the necessary information and skills for participating in patient engagement.
- Human resources: this refers to the personnel within the organisation dedicated to or supporting patient engagement activities
- Financial resources: this refers to the money that the organisation spends or dedicates to patient engagement activities.
- Managing competing interest: this refers to the ability to prioritise opportunities that are the most meaningful to the organisation
Survey Question: What is the basis of the patient input that you provide?
If you are a patient, this question refers to your personal experience in patient engagement and the different ways in which you may have provided input as a patient, for example by referring to your personal experience of living with the condition, by participating in a one-to-one interview, participate in group discussions (focus groups), completing a survey etc. If you are a patient representative or a patient organisation, this may also involve your personal experience and/or the way in which you gather and provide the patient input (e.g. surveys, results of other research, etc)
Survey Question: If you are involved in patient engagement activities either as a patient or as a member of a patient organisation, do you or patients you represent receive compensation/ honoraria/ reimbursement for any of the following.
The following options mean:
- Equipment: any type of equipment that you might need to be able to participate in the PE activity
- Family support: any type of support offered to your family in order for you to participate in the PE activity. This could mean financial support, child care, etc.
Specific section for Pharmaceutical industry
Survey question: How much is your organisation doing to move patient engagement from intentions to outcomes?
To clarify the meaning of the options,
- Not doing enough – Very obviously there is hardly anything being done at all
- Doing the bare minimum – There is only enough to fulfill requirements for the project
- Making a good effort – There is some effort made beyond minimum requirements
- Doing everything it can – Really engaged, making more effort than needed and going above and beyond the requirements
Survey question 15: How prepared is your organisation to actively participate in patient engagement in medicines development in terms of (options listed in matrix)
With “Internal processes” we mean those processes within your organisation. If you are an individual patient, please skip this question.
