Ami Baba and Martin Offringa on SPIRIT-C and CONSORT-C child and adolescent extensions

Those working in clinical trials will recall that in 2025 updates were published for the SPIRIT standard clinical trial protocol items and the CONSORT guideline for reporting randomised clinical trials. The Lancet Child & Adolescent Health will be co-publishing the first child and adolescent extensions to the SPIRIT and CONSORT reporting guidelines, along with the BMJ and JAMA Paediatrics. In this conversation with the SPIRIT and CONSORT child and adolescent project leads, Ami Baba and Martin Offringa, we discuss the need for child and adolescent specific reporting standards, the importance and value of engaging caregivers and young people in the process of developing the standards, and the potential for the SPIRIT-C and CONSORT-C reporting standards to positively impact the quality and inclusivity of paediatric clinical trials across all disciplines caring for neonates, infants, children, and adolescents.

Click here to read the full articles:

CONSORT-C https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(26)00004-0/fulltext

SPIRIT-C https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(26)00005-2/fulltext

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Transcript

This transcript was automatically generated using speech recognition technology and may differ from the original audio. In citing or otherwise referring to the contents of this podcast, please ensure that you are quoting the recorded audio rather than this transcript.

Amy: Welcome to The Lancet Voice. It's early February, 2026. I am Amy Slow Grow senior editor for The Lancet Child and Adolescent Health, and I'm delighted to be joining Jesse Baggin, your familiar Lancet voice host to co-host today's pediatric focused episode of The Lancet Voice. In May, 2022, a World Health Assembly Resolution was adopted on strengthening clinical trials to provide high quality evidence on health interventions and to improve research quality and coordination.

Overall, the that resolution recognized the central role of community stakeholders in the clinical trial ecosystem, as well as the neglect of children in clinical trial investment. So those working in clinical trials will recall, I'm sure that in 2025 updates were published for the Spirit Standard clinical trial protocol items and the consort guideline for reporting randomized clinical trials.

And at the Lancer Child and Adolescent Health. We are very excited to be now co-publishing the first child and adolescent extensions. To the Spirit and consult reporting guidelines that will be known as Spirit, child and Adolescent, or Spirit C for short and consult Child and adolescent or just consort C, and we'll be co-publishing these along with the BMJ and Jam a pediatrics later in February.

So today I am so delighted to be joining EME, as well as the two leads on the Spirit and Consort Child and adolescent project to talk more about these extensions.

We are really excited to have Army Barber and Martin Inger joining us today. Uh. Army studied neuroscience in Toronto, completed her Masters in brain sciences at University College London. She's currently a research project manager at the Hospital for Sick Children in Toronto. The lead author of the Spirit C and Consult C Guidelines, along with Martin, who's a neonatologist and a clinician scientist at the Hospital for Sick Children and University of Toronto.

He's a clinical trial methodologist. Has he been involved in many pediatric trials in newborns, infants, children, and adolescents. Evaluating both acute disease interventions and chronic rare diseases. Armie and Martin, welcome. Thank you so much for joining us today on The Lancet Voice. 

Martin: Thank you for having us.

Amy Baba: Thank you for having us. 

Amy: I think a lot of our. Listeners will know already that the spirit and consort statements are mainstays in clinical trial protocol design and clinical trial reporting. And as medical journal editors, we interact daily, uh, particularly with the consort statement for clinical trial reporting.

But perhaps we can just start off with sharing what the need was to develop a child and adolescent specific extension to these already widely used reporting standards. 

Martin: Sure. Over the last 15 years, 15 to 20 years in pediatrics, we've learned a lot about developmental biology, and we, uh, actually learned that at various stages of the, uh, development of a child, their responses to interventions like drugs or non-drug medical intervention.

Is, uh, not quite predictable by extrapolation from older children or from adults. Actually, there's a field called developmental pharmacology where it shows that the same dose, you know, calculated per um, kilogram body weight. Leads to different sort of levels in the blood because the liver of the child's, uh, for example, very active at the toddler age, and then later, you know, uh, drugs are, are staying much longer in the system.

Same with the kidney function. That's not a linear thing. And uh, we've also learned from observations and further, um, case studies that the response to the same drug level in the child is really related to at which. Age stage, the, the child is like, um, as a neonatologist, we used to sedate our babies for, for procedures, but if you give the same drug in the same dose to a toddler, they get really excited.

Um, we call that developmental pharmacodynamics. And so all of this together, and I'm not even talking about the psychological development and, and how outcomes are changing over the, the lifespan of a child. We call those, uh, oncogene, genetic variabilities, and they can actually be quite surprisingly large.

And that that's why, you know, at each different stage, outcomes differ. Uh, the way you give interventions, the, the benefit harm profile of any intervention is almost never constant across the ages. So we learned that and then. Trials, including, you know, uh, children at different stages of their development.

They failed. They didn't analyze it and they didn't describe what happened. For these smaller children and school children, and even teenagers and adolescents, we need to talk about, you know, what is really done in a trial and, and what is found with some extra details for the children and for the different age groups.

The other reason was that. People were looking at the record and started asking for guidance, then what is the minimal set that we need to report for a given trial in children? So when this started, it was really when I was working as a clinician and I was, you know, trying to implement evidence and I started developing clinical practice guidelines myself, doing systematic review of trials.

And I found that it was completely. Uh, challenging to, to combine and to compare trials because everybody was reporting some different details, uh, different ways to administer interventions, different outcomes were measured and, and analyze a report. So it was really difficult to, to, to, to tease out, like signal from the noise, if you will.

Amy Baba: Yeah. Just to add to what Martin said, um, existing reporting guidelines, including spirit and concert statements, um, right now they don't capture pediatric specific considerations. So even if authors use spirit and concert statements and adhere to them, they may not be addressing details that are pertinent or important for pediatric trials.

So some of these details include the justification for including certain age groups. Reporting on any developmental related differences in treatment effects. Um, there may not be enough details on number of children and adolescents involved by pre-specified biologically different age groups, whether they were randomized, like balanced by randomization, and.

Specific intervention doses and formulations used and adjustments based on the age, their weight, their body surface area, and also any mitigation of anticipated burdens. Stress and harms from trial procedures may not be addressed. So because children don't respond to interventions like small adults and they're not small adults, even within the pediatric population, there's a lot of heterogeneity from the newborns to infants, to children to adolescent.

There's a lot of differences in their anatomy, their physiology, their psychology, and how they respond pharmacokinetically and in their pharmacodynamics. So we really wanted to create guidelines to address some of these details because they're critical, and so that key information is not lost. Readers can understand what was done, what was found, and what the results mean for them, and research efforts aren't wasted.

Amy: Jess, I wonder if you want to push a bit more there and being the surgeon amongst us and, and not sort of already convinced of, of the need for children and adolescents, whether you have any skepticism about that statement and consort didn't do this well enough already. 

Jessamy Bagenal: I don't have any skepticism that this was something that was needed, hundred percent needed.

At least the biomedical field. We always have a tendency to assume that children are just little people and that we can apply all of the same things that we would to adult medicine. To pediatric medicine. And that's for a number of different reasons. You know, partly it's because they don't have a voice.

There are issues of competency and consent. There's always the guardians who are the main point of contact. Um, but it's also because. And so anything like this, which really draws attention to the fact that it's different. Researchers, clinicians, healthcare professionals, need to think differently, both in the way that we conduct research, but in the way that we actually manage patients and people as well is crucial.

Amy: Yeah. And something else that was really unique, um, about this process that you went through was the extent to which you engaged caregivers. And young people themselves in contributing to the development of these reporting statements. So wonder if you talk a little bit more about that process. 

Amy Baba: So the development of Spirit C and cons involved young people and family caregivers and involving them, we were able to work on reflecting their priorities in the guidelines.

So for example, youth generated items. We were able to work with young people to understand what they wanted to see reported in a trial protocol or report. So they actually generated new reporting items for consideration in the reporting guidelines, and they were included as part of this consensus process.

So, for example, we had items on the intervention delivery and whether a support person is needed. Um, youth also thought that items on recognition for their time and contributions and participating in the trial was important to be included. They highlighted concerns about confidentiality and whether their individual participant data will be shared, and all of these items were really important and we heard them during the workshops we had with youth.

It made a lot of sense to include these items and highlight the practical considerations that youth consider are important to them. 

Martin: And I might just add that for me, you know, as a, as a clinician who's been there for some time, we didn't steer, you know, what, what they were going to say at all. But it was really for me, like the eye-opener because we really, in adult trials.

We always presume that they get compensated or they're protected and their data are protected, but we never ask children anything. So they came up with this themselves and, um, that was really something that I, I feel, although it may not be like in the core of the, the biological, you know. Things that are going on, intervention testing.

I thought it was really good. And, and so we added that to the checklist just as, as a sort of, um, a new chance. And the children were really vocal and they really had their opinions. The other thing is that they also validated completely unprompted, uh, some, uh, other child specific reporting items that we had already on the radar.

And, and we call them youth supported items in the, in the papers. So they weren't new, but um, they came, they came up with, with those items themselves. And, uh, and, and we felt that they really validated, um, those items for us. 

Jessamy Bagenal: That's nice. Can I ask a question? What, what do you, um, see as the major barriers to the implementation of these guidelines?

And have you had. During the process of working with young people and the broader group, what did you identify? What are you expecting when these papers are released? 

Amy Baba: When we worked on developing these guidelines, we really wanted to involve young people and also family caregivers because. They are end users of trials.

Um, we really wanted to hear from them on what they think is important because this isn't something that we can learn from the literature, but only through directly working with them. However, to our knowledge, this was the first time that young people from the age of 10 years we're involved in the development of reporting guidelines.

So figuring out how best. To involve them in this process was a challenge for us because we wanted to make sure that involving them wasn't tokenistic and it was meaningful for them as well. So in order to do that, we worked with individuals who have a lot of experience and expertise and facilitating young person advisory.

And also with patient engagement experts to really figure out how best we can involve young people in this work. So we co-designed the involvement of young people in this project with them to make sure that we're presenting reporting guidelines in an understandable way, and also to facilitate meaningful discussions with young people who were interested in contributing to this work.

And we also offered flexibility to young people and families on how they can be involved. In the project based on if they were interested and if they were available, it was something that they found valuable. 

Martin: So we learned a little bit from the colleagues that have developed spirit. Uh, Dr. Unw Chun was on, on our core team, and of course the, the, the famous David Mower who invented concert.

25 years ago, I think. Have they been successful in, in implementation and has the uptake there been like spectacular? No, uh, not yet. And that's an ongoing sort of process. I would say for us, it's going to be important to get across the message that these guidelines are not intended to be a hurdle.

They're really based on the minimal set because that we really set out to reduce all the possible, but really this minimal set that goes for. All trials and actually a few items. They, they say, you know, when applicable, which means that probably there are trials that don't need to worry about those reporting items.

But, um, we really wanna make the point that it is really, uh, are the resources that will help standardize what is reported in child health trials so that eventually these refer. Research efforts, uh, do not get wasted. And, and, and we've all heard about research waste, you know, that is a concern everywhere, but also in our field.

So, um, I think, you know, if Trialists and journals, editors and, and peer reviewers are paying attention to this minimal reporting requirement, and then I feel that they can re make a real difference and their research will impact healthcare decision making through systematic reviews and guidelines. It will actually help improving health outcomes and the recent WHO guidance on clinical trials and the updated Helsinki statement on research with humans, they really consider the use of reporting guidelines as responsible research practices.

So I feel that the new generation, uh, should really pay a little bit of attention because again, the adult focused trialist may, may think that this is an extra hurdle, but. You know, we've just learned it is not that simple, especially if you want to sort of study an intervention across, you know, a broader age range, like asthma, like, you know, a new inhaler.

And, and we know that, you know, in toddlers it may worsen the asthma. Well, in adolescents they may improve so. Before you include any child in your trial, uh, we would, we would say, you know, team up with a pediatric subspecialist that understands these androgenetic variabilities across children, and, and then figure out how to make the most of your trials.

Amy: Thanks Martin and Armie, just leading on from there, I mean, I'm thinking about their relevance in low middle income countries where there's already limited trial infrastructure. I think only about 10% of all trials registered over the last two decades have actually been in child or adolescent age groups and and only 10% of those, so sort of less than 0.1% are actually.

In children that are experiencing the highest burdens of morbidity and mortality in low and middle income countries. And so, I mean, one of the things that I think I'm positive about is that, you know, these guidelines can help to reduce research waste to improve the validity and the quality of the results we have at the end of the day.

But we also know lots of really small trials get done in children. They're often underpowered. And so I wonder what you think about sort of that benefit of it, of, you know, people. Being able to improve the quality of individual, but small trials and, and having more success than synthesizing evidence, um, from these trials at the end of the day to be able to answer questions.

Martin: Right. So this is really the, the big question in our field, because as you. Probably know that, uh, most diseases in children are rare diseases. Uh, I mean, not, not like the diseases that need trials, like, you know, middle air, uh, uh, infection, uh, and sore throat. But it's really the diseases that bear high mortality in the higher income countries are rare as compared to, of course, what you talked about, the low income countries with respect to low, uh, middle income countries.

We, um, set out and we involved. Pediatricians and trialists from those regions through our, um, center for global, uh, child health here in Toronto. And we got very interesting inputs. Not only, uh, uh, about some reporting items, but also about the feasibility of collecting data in those settings for these outcomes.

And people were generally. Not, uh, concerned so much that this would only work like, you know, in, in the, in the western world and not in the, uh, lower middle income countries at all. So I was really happy with, with that input. No. So when, when, when we are talking about, um, small sample size, that is actually, uh, you know.

What we are used to in, in, in pediatrics and therefore it's so important that each data point, you know, can be used and it doesn't get lost because people are unsure what to report or they don't use sort of standards that are out there to, to classify children in age groups and uh, instruments. That are validated that, you know, outcome measurement, instruments validated in children are used more and more and more in trials.

You know, used to be like, you know, the outcome is a biomarker or you know, something that's sort of, or um, you can be measured in one week. But more and more we're looking at functional outcomes in children. Can they participate? Can they go to school? Can they play with their friends? Um, but there are skills for that and so we need to know.

Whether the instruments are valid and reproduce and, and generating more signal than noise. So here I, I hope that this, these are reporting guidelines. These, these are not about designing trials, but they, they sort of. Pay attention to those sources of variation that actually can destroy trials in the sense that it completely undermines your power if your instrument is generating noise and a signal.

Amy: These reporting statements will be published on February 24th. We're hoping for good uptake and the world to start using them, but perhaps just to round our conversation out, what do you have planned in terms of the next steps on dissemination and and supporting uptake of the use of these guidelines?

Amy Baba: So of course we are so excited for these papers to come out in on February 24th, and the dissemination and uptake is so important and it's a whole nother process we have to consider because we are trying to change research practice. Um, author behavior research institutions, journals, and funders when they review protocols and also reports.

So, first of all, to make it easier for guideline users, we prepared explanation and elaboration papers or ENE papers. They will be published in the BMJ on the same day on February 24th. To accompany these guidelines, they provide examples of good reporting and also ex. Explanations for each item so that they're applied in the way that they're intended to be.

Um, we're also preparing aside from that tip sheets for each new spirit C and concert C reporting item, and also a short informational video about the guidelines. So if anyone wants to learn more about each item or about the guideline, these may be useful resources. Really, when we were planning the publication of these guidelines, we really wanted to reach a broad readership and an international reach.

So we are co-publishing these statements in multiple journals, the last Child and adolescent health, the BMJ, and also Jamma Pediatrics. So. That is part of our, um, dissemination and reach. We also worked with the last child and adolescent health on a special feature highlighting the patient and public involvement work, and also a patient pages coming out in Jamma Pediatrics about what young people and family caregivers.

Needs to know when they're reading a clinical trial report. We have also been working with other journals for publishing editorials and we are planning to present this work in the future and webinars as well. So we're trying to really hit different audiences publication wise, while also afterwards.

Beyond that 

Martin: and what, what we're really hoping obviously is that all journals that publish trials. With children, we'll pick this up and, and endorse it and put it on their instruction for authors so that it doesn't take 20 years, you know, like it did for, for consort, the original adult version, but that we can make progress a little bit faster with these child health trials.

Amy: That's excellent, I think. I think that's where we're gonna have to leave our conversation today, but just a huge congratulations to you and your teams, to all of your collaborators, partners that have been on this journey with you, and now get to see these really important guidelines coming to light. You have the full support of the lines of child and adolescent health.

And the Lancer group in supporting uptake and implementing of these, these guidelines. And thank you for joining me today. 

Amy Baba: Thank you. Thank you for having us.

Amy: To our listeners, we'd encourage you to have a look at the Spirit, sea and consort sea statements. Consider how they're relevant to your work in child and adolescent clinical trials in designing and reporting them. And at The Lancet Child and Adolescent Health. We'll be requiring reporting according to the Consort Sea extension.

Both reporting statements are available@thelancet.com with a link in our show notes. As well as links to other content in relation to global health clinical trials that we've discussed today. Remember that you can subscribe to the Lancet Voice and the Lancet Child and Adolescent Health and conversation with wherever you usually get your podcasts.

Thanks so much for listening and take care.