Analysis of unmet medical needs

The context

Most diseases that affect the paediatric population are unusual pathologies that suppose a heavy emotional burden for patients and their families. Furthermore, a large number of these illnesses lack a specific approved treatment. Knowing how a pathology affects the quality of life of patients and their families is essential for the design of clinical trials adapted to their characteristics and the reality that potential participants have to cope with.

How do we do it?

In practical workshops led by professionals, we give details of the care received by patients with a specific pathology, study how it impacts their quality of life and describe determining factors to be taken into account in the design of future research initiatives.

The reality faced by patients must be taken into consideration in the design of a clinical trial, thereby anticipating any difficulties in the recruitment process and/or compliance with the trial.

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Co-design of research protocols

The context:

In a clinical trial protocol there are sections relevant to patients that have a key influence on the development of the study. The design of these sections together with patients and/or families ensures that the future clinical trial takes into account the characteristics and needs of the patients and their families from its earliest stages. In the case of paediatric patients, the family's overall view and perception of these sections is essential.

How do we do it?

There are relevant sections in a protocol to which patients and families can contribute in order to ensure the clinical trial is tailored to the circumstances and needs of potential participants. Some examples are:

  • The inclusion and exclusion criteria
  • Analysis of risks/benefits
  • Candidate screening and selection process
  • Calendar of the study visits
  • Type and frequency of tests performed on patients

The Unit for Patient Participation in Research designs practical activities to promote the co-design of these sections. Please contact us if you need help designing a protocol focussed on patient needs.

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Co-design of agreement and consent forms

The context:

In order to show their conformity with their children's participation in a clinical trial, parents - and the child if he or she is over 12 years of age - must sign a form of consent. This document must include all the details of the study as well as stipulating the patient's rights. In many cases these forms are too long and include terminology that is difficult to understand for parents and minors. For this reason the format and the content must be validated in conjunction with groups of parents and patients before a form is used in a clinical trial.

How do we do it?

By including parents and young patients as reviewers in the process of design and validation of both the forms of consent and agreement. We also have a methodological tool at our disposal to work with panels of reviewers from other countries, thereby obtaining a review of these documents in more than one language.

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Co-design of projects of innovation

The context

Innovation allows to respond to medical needs through the development of technological initiatives that contribute to a better quality of life for patients and their families.

Taking into account the patients' point of view in the initial phases of an innovation project ensures a design focussed on their needs and facilitates the inclusion of their requirements right from the start, in the most preliminary phases.

How do we do it?

The users' experience in initiatives of innovation is crucial to ensuring that we respond adequately to their needs. We design the most suitable methodology to learn about and include the users' experience in the design of initiatives for innovation.

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Analysis of the experience of patients participating in a clinical trial (Patient Clinical Trial Journey Workshop)

What for?

Simulating the experience of patient participation in a clinical trial offers the research teams a closer understanding of the patients' real-world experience, thereby enabling them to anticipate potential risks or limiting aspects of the protocol and mitigate them before the project is carried out.

How do we do it?

Our team of experts in simulation can perform an analysis of the protocol design of clinical trials in order to detect points needing improvement, which can be dealt with through simulation activities. Thanks to an interdisciplinary team in which professionals from the pharmaceutical industry or the academic institution responsible for the project also cooperate, specific aspects of the project are recreated through the participation of patients and/or families.

If this activity is carried out before the submission of the protocol to the regulatory agencies, it is feasible to introduce improvements. If the activity is carried out later, it is also possible to improve the training and/or expertise of the professional teams responsible for the protocol.

Depending on the clinical trial, the simulation may add different value and focus on specific objectives. If you want to know how to use simulation methodology to include the patients' perspective in a protocol, please contact us.

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Review of documents for patients (agreement and consent forms, information sheet)

Information sheets and legal documents addressed to patients and their caregivers are not usually reviewed to ensure that they are adapted to this target audience's level of understanding. For this reason, and to achieve the informative and decision-making goals of these documents, it is crucial that panels of patients and/or caregivers review these documents before they are delivered to the participants in a clinical trial.

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Non-specialist summaries for participants in clinical trials

The context:

Once a clinical trial targeting paediatric patients has finished, the summary of findings should be published within six months. With the implementation of the new paediatric regulation, this practice - which is currently optional - will become compulsory. Paediatric patients and their caregivers deserve to receive a report of the results of the research in which they have participated.

How do we do it?

The Unit for Patient Participation in Research offers consultancy services to validate easily understandable reports of paediatric clinical trials for non-specialists. The content of these informative documents is reviewed by practiced young patients and caregivers. Please contact us if you need a panel of expert patients and caregivers to review a non-specialist report of the results of a clinical trial.

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