Do you have to make a decision concerning the treatment of someone under your professional care?
It is important for patients to be able to discuss their healthcare options with a trusted member of their healthcare team. Gene and cell therapy is a rapidly advancing, highly specialist field. This may mean that a patient in your care may have questions which fall outside your specific knowledge or expertise.
Each patient decision is unique. A patient may choose to speak to you about their decision because of your clinical expertise, or your established therapeutic relationship. If you do not have an established relationship with a patient, they may not feel comfortable speaking freely with you about something which falls under your area of expertise, and may take personal advice from other members of their team.
On this page, we have collated resources which we hope will help you support your patient through their decision.
How can I support my patient in making a well-informed decision?
The gap between the technical meanings of terms related to gene and cell therapy and their common use can lead to confusion.
You should also be mindful of the language you use. Many terms in gene and cell therapy have specific technical meanings distinct from their colloquial use. The increased coverage of the topic in the media may mean that your patient has a partial but uncertain understanding of some terms. Check in with your patient to confirm that you are both using certain terms the same way.
If you client is interested, you can direct them to resources explaining the basics of gene and cell therapy here:
Information about the techniques involved in research and therapy is available here:
If you patient is confident in their understanding of the basics, they will better be able to understand other material you present them, be less susceptible to fear-mongering or hype, and make an informed decision which is right for them.
How do I help a patient decide between gene or cell-based therapy and a more traditional treatment?
Your patient may decide to go for a traditional therapy, a gene and cell-based therapy, or no therapy. What is important is that they understand the benefits and risks associated with each option.
It is important to consider how this therapy will align with patient’s lifestyle and health priorities, and that they understand any implications this will have for future treatment options.
The resources below may be helpful in guiding a conversation with your patient, and making sure they have considered the risks and benefits of the treatments on offer.
Our 'Considering a treatment offer?' page suggest points for consideration. These may be helpful in guiding a discussion with your patient around their priorities, treatment goals, and acceptable risk levels.
The International Society for Stem Cell Research has created 'A Closer Look at Stem Cells', a collection of resources aimed to help patients make a decision around stem cell therapy. Many of these same concerns apply to gene and cell therapies more broadly. These resources may be helpful in preparing for a conversation with your patient (especially 'What to Ask').
You can also find information specific to your patient’s condition in our topic-specific factsheets.
We are in the ongoing process of updating older factsheets, as well as adding factsheets on new topics.
Where can I find information about ongoing or recruiting clinical trials?
You can find information about clinical trials in Europe on the EU Clinical Trials Register.
You may be able to find a national registry of clinical trials on either your national health provider’s website, or a government website.
National support organisations for specific conditions may curate a list of ongoing clinical trials in your region.
Should I tell my patient about a clinical trial they may be eligible for?
Research conducted in 2017 by the Centre for Information and Study and Clinical Research Participation found that over 71% of participants who have never participated in a clinical trial would be willing to do so. Within Europe, 54% of respondents said that they would first seek information from their HCP, with others saying they would seek information online. [Source]
If you believe your patient may be open to the idea of participating in a clinical trial, and especially if you know of a potentially suitable trial, sharing this information with your patient means that they are getting reliable information from a trustworthy source, rather than sifting through information online.
If you have questions about the process or the eligibility requirements, you can contact the trial coordinator to clarify these queries before you raise the subject with your patient.
How should I counsel my patient regarding a clinical trial opportunity?
You can use the same conversational guidelines as above to ensure that your patient has a clear understanding of the potential risks, benefits, and implications for their future care.
Our 'Considering a treatment offer?' page may be helpful in guiding a discussion with your patient around their priorities and treatment goals.
The International Society for Stem Cell Research has created 'A Closer Look at Stem Cells', a collection of resources aimed to help patients make a decision around stem cell therapy. Many of the same concerns apply to gene and cell therapies more broadly. These resources may be helpful in preparing for a conversation with your patient (especially 'What to Ask').
You should confirm that your patient understands the clinical trials process, and knows what phase they will be participating in.
I am leading a clinical trial. How should I advise patients considering participation?
If you are leading a clinical trial, and a patient under your care is interested or eligible for participation, it is important that you draw clear boundaries between your relationship to them as a healthcare provider, and your role as a researcher. The registration and recruitment should be done by another member of the research team where at all possible. It should also be made clear that the decision to participate or not will not affect the standard of their ongoing care.
These guidelines by the National Institute for Health may be helpful in preparing for these conversations.
There is a therapy approved in Europe for my patient’s condition, but it is not offered in our country.
You can access a European Reference Network to seek advice from international colleagues.
If your patient has questions about the unavailability of a treatment in your region, this page may be helpful to them.
My patient has not responded to approved treatments and is not eligible for any recruiting trials.
You can find information below about compassionate use of non-approved therapies in Europe, and find information as to whether your patient may be eligible for this rare case. Be advised that the legislation concerning compassionate use vary by country.
We also suggest that you find a national or local support organisation for people living with your patient’s condition. They may have local branches which can offer social support. Specialist healthcare centres and centres of excellence may also offer patient support groups.
My patient has expressed an interest in travelling internationally for a therapy which is not approved for clinical use within the EU.
Our factsheet on unproven therapies contains a section on travelling abroad for therapy.
In particular, you should clarify with your patient:
- Whether this therapy has been approved for clinical use in the country they are considering travelling to.
- If this therapy has not been approved for clinical use, under what terms they would be receiving it – eg., does it qualify as a medical or cosmetic procedure?
- Whether this would be a ‘one-off’ therapy, or whether follow-up care will be involved.
- Whether your patient would need to travel for follow-up care, or whether they could receive this care in their home country, through their usual healthcare team.
- What contact and information you and your team would have with the local team.
- Whether this therapy would affect their future treatment options in their own country.
How should I counsel patients asking about an unproven/experimental/investigational therapy?
This is another area where unscrupulous service providers can exploit ambiguity of language. Be sure that your patient knows what these terms mean in their medical/legal context, as well as how they are used colloquially.
It may be useful to discuss the phases of the clinical trials process with your patient.
It may be beneficial to discuss with your patient what makes some conditions more suitable for treatment by gene and cell therapy than others. This information page may be helpful in this discussion.