Mitigating the effects of COVID-19 on the work of a children’s clinical research facility
Intended for healthcare professionals
Evidence and practice    

Mitigating the effects of COVID-19 on the work of a children’s clinical research facility

Allyson Gray Children’s research nurse, National Institute for Health Research Clinical Research Facility, Great Ormond Street Hospital for Children NHS Foundation Trust, London, England

Why you should read this article:
  • To recognise the challenges posed by the coronavirus disease 2019 (COVID-19) pandemic for clinical trials

  • To learn how one children’s clinical research facility adapted to change during the COVID-19 pandemic

  • To acknowledge the positive effects of some of the new ways of working developed during the pandemic

The coronavirus disease 2019 (COVID-19) pandemic has affected almost every aspect of healthcare, including research. Many ongoing clinical trials were paused or adjusted to the new circumstances, the safety of all involved and patient outcomes being central concerns. Upcoming trials were put on hold and new trials were quickly designed and conducted to investigate COVID-19 treatments and vaccines.

This article is a reflection on the effects of the pandemic on the work of a children’s clinical research facility in the UK and how some of these effects were mitigated. It describes the adaptations made to the delivery of study interventions and to staff’s ways of working, showing that some of the changes prompted by the pandemic had positive effects that will extend beyond. While this article relates to a single children’s research facility, many of the lessons learned can be applied more widely in research and clinical care settings.

Nursing Children and Young People. doi: 10.7748/ncyp.2022.e1404

Peer review

This article has been subject to open peer review and checked for plagiarism using automated software

Correspondence

allysongray@hotmail.com

Conflict of interest

None declared

Gray A (2022) Mitigating the effects of COVID-19 on the work of a children’s clinical research facility. Nursing Children and Young People. doi: 10.7748/ncyp.2022.e1404

Acknowledgements

The researcher receives funding from the National Institute for Health Research (NIHR) ICA Pre-Doctoral Clinical Academic Fellowship (NIHR 301107). The views expressed here are those of the author and not necessarily those of the NIHR or the Department of Health and Social Care. The author would like to thank for their assistance with this article: the NIHR Clinical Research Facility at Great Ormond Street Hospital for Children NHS Foundation Trust; Jo Wray, senior research fellow – health psychology, Centre for Outcomes and Experience Research in Children’s Health, Illness and Disability, Great Ormond Street Hospital for Children NHS Foundation Trust; Polly Livermore, clinical academic lead and blood, cells and cancer matron, Centre for Outcomes and Experience Research in Children’s Health, Illness and Disability, Great Ormond Street Hospital for Children NHS Foundation Trust; Mariacristina Scoto, consultant neuromuscular, Great Ormond Street Hospital and University College London Great Ormond Street Institute of Child Health; Deirdre Leyden, patient and public involvement and engagement lead for research, NIHR Great Ormond Street Hospital Biomedical Research Centre and Clinical Research Facility

Published online: 07 February 2022

In December 2019, China reported a cluster of pneumonia cases in Wuhan to the World Health Organization (WHO). By the beginning of January 2020 a new coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), had been identified as the cause of the outbreak (Wang et al 2020). At the end of January 2020 the WHO declared the outbreak caused by SARS-CoV-2 a public health emergency of international concern (2020a) and in March 2020 the WHO declared the coronavirus disease 2019 (COVID-19) a pandemic (WHO 2020b). As of 23 November 2021, the cumulative number of confirmed COVID-19 cases reported globally was over 256 million and the cumulative number of deaths was more than 5.1 million (WHO 2021).

The COVID-19 pandemic has affected almost every aspect of healthcare worldwide, including non-COVID-19 clinical trials for children. In this article the author reflects on the effects of COVID-19 on the work of a children’s clinical research facility in the UK and how some of these effects were mitigated. The first section describes how the clinical research facility adapted to change during the first wave of the pandemic (March to June 2020). The second section describes how the lessons learned during the first wave were applied during the second wave (December 2020 to February 2021). The quotes used in the article were collected from staff, patients and families approached directly by the author for written feedback, as well as from feedback cards given to all patients and families when they attended hospital (which stated that the feedback given could be used publicly, including in publications). Confidentiality was ensured by removing all information that could identify people, including details of the study they were involved in and the hospital they attended.

Key points

  • The coronavirus disease 2019 (COVID-19) changed the way clinical trials were conducted during the pandemic

  • Online staff meetings and remote patient visits are convenient and save time and expenses, but people miss face-to-face interactions

  • Many trials have been paused or delayed, so a reduction in the volume of research data is to be expected

  • Positive effects of the new ways of working prompted by the pandemic could be maintained by using a mix of remote and on-site methods

  • The accelerated design and running of COVID-19 trials shows how trials for other diseases could be streamlined

First wave – adapting to change

Initial adjustments

The COVID-19 pandemic severely affected clinical trials in the UK and worldwide. Nationally, the effect of the pandemic on trials varied depending on location, study design and specialty. Regulatory bodies paused the opening of new studies unless they were related to a public health emergency, one obvious example being COVID-19 trials. The European Medicines Agency (2021) and the Medicines and Healthcare products Regulatory Agency (2020) issued guidance on how to manage clinical trials during the pandemic. That guidance led research teams to revise risk assessments and consider the effect of suspending individual trials on patients. The National Institute for Health Research (NIHR) reported that in England, of the 3,906 non-commercial studies that were ongoing or being set up at the height of the pandemic, 70% had to be paused and 12% stayed open for recruitment (Shiely et al 2021).

When the COVID-19 pandemic was declared, rapid adjustments had to be made. At the clinical research facility, according to non-published internal data, 33% of research staff and 60% of clinical staff were redeployed to other hospital areas. Working as a team, effective communication, flexibility and adaptation meant that it was possible to keep trials running and led to staff developing new ways of working. Upcoming clinical trials were not started and recruitment for these trials was put on hold. Research staff became involved in a rapidly increasing number of COVID-19 trials. Most ongoing trials could continue, albeit in a different format. Every attempt was made to ensure that patients enrolled on trials were not negatively affected. In line with NIHR (2020) guidance, lead doctors for ongoing trials established which ones were essential. Trials were deemed essential if the study medicine was the only treatment option and suspending the trial would have a detrimental effect on patients.

Out of 59 ongoing trials at the clinical research facility, one was suspended and the other 58 remained open. However, recruitment was put on hold for all ongoing clinical trials as well as for upcoming ones. This was potentially distressing for the families of children with no current treatment, for whom new trials offer hope. As one family said:

‘He was due to get assessed for the trial back in March 2020, the week of the first lockdown. So had to wait four months, July he finally got assessed. Throughout that four-month period we were emailing asking if it was restarting as we were worried we would get forgotten about.’

Delivering study interventions

The clinical research facility stayed open throughout lockdowns so patients could attend it when study interventions could not take place remotely.

In 15 clinical trials (25% of ongoing trials), the study medicine could not be administered to patients at home so the trials continued to run physically and patients attended the clinical research facility to receive medicines via intravenous, subcutaneous, intrathecal or intracerebral ventricular routes. Families were often anxious at the prospect of travelling to London. Many patients have complex needs and are considered high risk, with families self-isolating completely or avoiding leaving their home as much as possible. Changes to hospital policy meant that children could only attend with one parent and all had to follow strict social distancing and infection control measures, which could be daunting.

Forty clinical trials (68% of ongoing trials) did not require on-site administration of the study medicine and could therefore continue without patients physically attending hospital. Instead, medicines were sent to families at home. This was implemented swiftly, with sponsors expediting contracts and consent gained from families. Parents reported that this was a smooth process and that they were happy with the service provided and speed at which it had been set up.

In some instances, intravenous or subcutaneous medicine could be administered at home by homecare nursing teams. This had already been in place before the pandemic for three trials. For one other trial, within weeks of the first UK-wide lockdown, the sponsor was able to implement an amendment to allow home dosing to start earlier than planned. Medicine administration could therefore be carried out in the comfort of patients’ homes and families avoided having to travel. Families initially had concerns about nurses visiting their home since homecare nurses often visit numerous patients, which can increase the risk of cross infection. However, families were reassured that personal protective equipment (PPE) would be worn and social distancing and infection control guidelines would be followed.

There were unavoidable minor setbacks, such as patients occasionally missing a visit if someone in their family had COVID-19 symptoms, but overall this ran smoothly with effective communication between the clinical research facility, homecare nursing teams and couriers.

Most study visits could be carried out remotely by telephone or video calls. Video calls were easy to set up through the hospital’s electronic patient portal, enabling staff to carry out visits according to the study protocol. As well as removing the need to travel and the stress of travelling and attending hospital, families reported that remote visits reduced their time off work and need for childcare. Informed consent could be obtained by video call with two healthcare professionals present, clear documentation and remote signing of forms. Staff identified positive and negative aspects of this new way of working:

‘I feel a phone call works well and is much easier to fit around your schedule. Moving services into the community which saves patients coming to site unnecessarily.’

‘I felt it was particularly hard to build empathy when you were forced to introduce yourself as a “voice” via phone or as a 2D image on a screen.’

Some trials required patients to be observed after receiving the study medicine. In agreement with the study sponsor and study lead, the observation time was reduced from 24 hours to four hours in two trials and from four hours to one hour in one other trial. This made a significant difference to patients and families but also to the facility and to staff, since it reduced the need for staff to stay on site overnight. This reconsideration of the length of the observation period may have implications for future studies.

Families who attended hospital reported feeling safe. The hospital was relatively quiet, there were few patients attending and parents were fully informed about what to expect before their visits, which alleviated their anxieties:

‘We have felt very safe coming into London and in the hospital. In some respects, it’s been easier as it’s been quieter.’

‘Still great service despite the posed social distancing measures which everyone stuck to rigidly.’

With appropriate amendments to study protocols, physiotherapists were able to carry out interventions remotely using video calls. Instructions were sent in advance to parents and essential data were captured on video, ensuring the integrity of the study. However, physiotherapists reported challenges in terms of ensuring the environment was appropriate, assessing patients’ and parents’ ability to follow instructions and completing all procedures:

‘No patients were seen face to face for a long time, which from a physiotherapy perspective was difficult to follow up considering most trials have physio outcome as primary and secondary outcomes.’

‘Carrying out physio via Zoom – it is an alternative for the short term but not ideal. Only a very few outcomes could be done via Zoom and validity has not been established.’

Amending protocols and procedures

All these changes to clinical trials required protocol amendments which, in turn, required regulatory approval. The regulators and research ethics committee expedited the process by being flexible and prioritising COVID-19 studies and amendments to ongoing trials. In some cases, changes could be implemented retrospectively, for example when visits were carried out remotely, medicines were couriered and GPs conducted blood tests. The alternative would have been to delay these interventions, posing a risk to patient safety or forcing patients to pause taking their medicine. Retrospective written consent could then be gained from families. Research nurses reported the speed at which amendments were processed as a positive aspect, one of them stating:

‘It has been a challenging year however there have been some positives to draw from it – such as the speed at which research can be put through when needed.’

COVID-19 restrictions led to inevitable protocol deviations, meaning that study data were not always collected as required, which can affect the quality of data and validity of study results. Staff identified when study procedures had been missed, discussed this with the study team and informed the study sponsor. Instances of missed procedures were fully documented. Certain procedures were carried out remotely, such as completion of questionnaires or diaries, which were sent to parents who would post or email them back.

One important aspect of clinical trials is that they are monitored by independent staff – that is, clinical research associates external to the organisation – to ensure data are collected appropriately. During the peak of the first wave, no external staff were allowed on site, which meant that trials could not be monitored as usual. The monitoring of data collection had to be carried out remotely, but clinical research associates did not have secure remote access to patient records, which increased the workload of research nurses and research coordinators:

‘We had a dense correspondence with clinical research associates, with changes happening on a weekly basis in the first part of the pandemic.’

Developing new ways of working

The pandemic affected day-to-day work, since more people worked from home. Since the advice to work from home came at short notice, adaptations had to be made quickly. Some research staff did not have access to a laptop or an appropriate working environment and contacts were by email rather than on the phone, which initially created challenges and caused confusion. These were resolved when laptops were supplied to all staff working from home and everyone adapted to the new ways of working. A group email address was set up and given to all patients and staff. The group email box was continuously monitored so that no emails were missed and someone would always respond. Online meetings could be organised rapidly with fewer logistical issues than face-to-face meetings. Staff thought that remote working could cause confusion but also recognised its positive aspects. For example, one member of staff said:

‘It’s been so much easier to log into training sessions and also reduces travel time between meetings, which is much more productive.’

One example of adapting to new ways of working was the hospital’s young person’s advisory group (YPAG) for research, a group of young people who meet six times a year to review studies and applications. Before the pandemic, the YPAG regularly met face to face. The March 2020 meeting was cancelled abruptly, but from May 2020 onwards, the group met remotely via videoconferencing. Some issues were raised, including the young people missing seeing each other and the free lunches, but the positive aspects outweighed the disadvantages. There was an increase in membership and in the number of young people attending meetings due to the fact that they did not have to travel and could fit meetings around other commitments. The absence of space restraints meant that larger groups could be accommodated. In terms of engagement, the chat function encouraged everyone to contribute. Feedback was positive, as demonstrated by this quote from a young person:

‘After being in lockdown for quite some time, it was so lovely to see everyone who attended… It’s been difficult to go from suddenly seeing friends and relatives every day to not even being able to leave your house for the next few months.’

The YPAG lead reported that using an online videoconferencing platform had been a success and that they anticipated being able to increase the number of meetings in the future, possibly alternating between online and face-to-face meetings.

Second wave – applying lessons learned

When the second wave of the pandemic started, it was possible to respond using lessons learned from the first wave. By that time, the hospital had clear COVID-19 pathways in place and these were more accepted by visitors. Additional PPE was required for all staff and visitors. Surge plans were already in place for the clinical research facility, the hospital and surrounding hospitals. There were already procedures in place for carrying out clinical trials during a pandemic. As a consequence, the team was able to conduct trials very closely to study protocols and all trials could stay open and recruit, which had not been possible during the first wave due to the sudden onset of the pandemic and the emergency measures put in place.

There were still challenges accessing other services at the hospital, including magnetic resonance imaging (MRI) scans and theatre slots. Regular communication and meetings ensured that study patients could be booked into these services. Certain study procedures, such as lung function tests, required additional planning since infection control measures meant that they could not be carried out at the clinical research facility. The physiotherapists organised the booking of air-pressured rooms to carry out these tests, which were only undertaken if deemed essential. Patients scheduled to come for an overnight stay or an aerosol-generating procedure during a day visit had to obtain a negative result from a COVID-19 test taken in the preceding 72 hours.

Some families were self-isolating so attrition was still common, and staff absences increased, which led to the clinical research facility having to function with reduced staff. As in the first wave, staff worked as a team and covered each other’s trials while also supporting other hospital areas and other hospitals as well as the COVID-19 vaccination clinic.

Families reported that they felt safer attending the hospital in the second wave, generally because of the clear infection control guidelines in place, effective planning and the fact that most staff were being regularly tested for COVID-19. All hospital staff were up to date with COVID-19 guidelines and strict social distancing was in place. Staff began to receive the COVID-19 vaccine at the beginning of January 2021, which further reassured families.

Study interventions could be carried out remotely with relative ease. Procedures for remote visits were already in place, patients had already consented to these and courier services were already up and running. Video conferencing was now commonly used for visits, meetings and training, so most staff, patients and families were familiar with its use. Homecare teams, GPs and local hospitals were able to carry out some study procedures, such as blood and urine tests, when patients preferred not to attend hospital. In February 2021, the remote monitoring of data collection was made easier when clinical research associates were given a secure remote access to patient records.

Implications for research and practice

During COVID-19, research teams at the clinical research facility adapted working procedures to ensure the safety of patients and staff while maintaining data collection. There were lessons learned in terms of being flexible and finding new ways of working. Study visits were carried out remotely, releasing physical space at the facility to conduct complex early-phase trials and start new ones. Online training and meetings reduced time, cost and logistical constraints. The opportunities offered by online methods of communication are wide ranging and will continue to be used. Collaborative working with local healthcare services, homecare nursing teams and courier services aided the smooth provision of care.

Similar findings have been published by Mitchell et al (2020), Singh and Chaturvedi (2020) and Shiely et al (2021) – albeit not relating specifically to children’s research – while Weiner et al (2020) commented on the effects of COVID-19 on children’s research in North America. Authors mainly discussed the effects that pausing recruitment has on research, how lessons can be learned and the need for sharing experiences.

The full effect of the COVID-19 pandemic on research with children is yet to be seen. It is anticipated that there will be a reduction in the volume of data from ongoing trials and that the delay in starting new trials will have long-term health consequences. The volume of amendments that had to be made to trials at the clinical research facility because of COVID-19 has been significant and has created pressure on the research governance team. As many new projects were put on hold, the governance team was able to focus on amendments, but the number of amendments has resulted in a backlog of new projects waiting to be started.

The accelerated design and running of COVID-19 clinical trials have shown how trials for other diseases could be streamlined. The pandemic has also increased awareness of the need for an evidence base and the value of research. Research has led to the development of COVID-19 vaccines and treatments, which will hopefully reduce restrictions, allowing the opening of new trials and the return of much needed research into many childhood conditions.

The reflections shared in this article relate to a single children’s clinical research facility but the lessons learned could be useful in other settings, including adult research settings and clinical services. Table 1 summarises the changes made to how work was conducted at the facility during the pandemic, their effects and consequences, and whether they are applicable in other settings. New clinical trials will take into account potential future lockdowns or pandemics, with remote consultations planned for some of them.

Table 1.

Changes, effects and consequences

ChangeEffect and consequenceIs the change applicable in other settings?
Online staff meetings
  • Easier to arrange, less expensive and more convenient for staff who avoid having to travel

  • These will continue

Applicable in all healthcare settings
Remote patient visits
  • Patients and families avoid having to travel to hospital, which saves time and money and reduces stress

  • Patients and families sometimes miss face-to-face interactions

  • Remote visits will continue where suitable, but for clinical reasons it is preferable to see some patients in person, especially for physiotherapy and assessments

Applicable in outpatient settings and primary care
Sending study medicine to families at home
  • More convenient for families

  • This will continue where suitable

Applicable in outpatient settings
Remote monitoring of data collection
  • More convenient for clinical research associates

  • Initially this increased the workload of research staff because clinical research associates did not have secure remote access to patient records, but it also reduced amount of time research staff spent with clinical research associates on site

  • The plan is to use a mix of remote and on-site monitoring

Applicable for other types of remote working
Speed of setting up coronavirus disease 2019 (COVID-19) trials and in making COVID-19-related amendments to ongoing trials
  • Although positive at the time, this led to delays in setting up new trials and making non-COVID-19-related amendments to ongoing trials

Applicable in all research settings
Reduction of study intensity, for example reduced observation time after medicine administration
  • Reduces time patients and families spend in hospital

  • Reduces need for staff cover on site, including at night

  • This will continue where feasible and safe

Applicable in outpatient settings
Increased involvement of local healthcare services
  • At times challenging to arrange but more convenient for patients and families

  • This can be used when patients are unable to attend the research facility, but is not ideal in terms of following research guidelines

Applicable in outpatient settings
Increased involvement of homecare nursing teams
  • Medicine administration is carried out in the comfort of the patient’s home, removing the need for families to travel

  • This will continue where possible

Applicable in outpatient settings and primary care
Only one parent allowed to attend hospital and no siblings allowed
  • Often challenging for families, including in terms of support and childcare

  • The hope is that restrictions will be relaxed in the future so that both parents, and other family members, can attend

Affects all inpatient and outpatient settings
Online meetings of young person’s advisory group
  • More convenient for young people, increased membership, increased number of participants

  • Young people missed face-to-face interactions and free lunches

  • The plan is to use a mixture of online and face-to-face meetings

Applicable for other types of working groups

Conclusion

COVID-19 led to considerable changes in the way clinical trials were conducted during the pandemic. Trials were paused or adjusted and staff quickly developed new ways of working. At a children’s clinical research facility, extensive efforts were made to keep trials running. The use of online staff meetings and remote patient visits had positive and negative effects: they were found to be convenient, reduce stress and save time and expenses, but they were not always clinically indicated and people reported missing face-to-face interactions. Positive effects of the new ways of working could be maintained in the future, in research and clinical care settings, by using a mix of remote and on-site methods of communication and monitoring. Upcoming trials have been delayed, so it is likely that there will be a reduction in the volume of research data and possible long-term consequences for children’s health. However, the accelerated design and running of COVID-19 trials has shown how trials for other diseases could be streamlined, which could improve the running of trials in the future.

References

  1. European Medicines Agency (2021) Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic Version 4. http://ec.europa.eu/health/sites/default/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf (Last accessed: 25 November 2021.)
  2. Medicines and Healthcare products Regulatory Agency (2020) MHRA Guidance on Coronavirus (COVID 19). http://www.gov.uk/government/collections/mhra-guidance-on-coronavirus-covid-19 (Last accessed: 25 November 2021.)
  3. Mitchell EJ, Ahmed K, Breeman A et al (2020) It is unprecedented: trial management during the COVID-19 pandemic and beyond. Trials. 21, 784. doi: 10.1186/s13063-020-04711-6
  4. National Institute for Health Research (2020) DHSC Issues Guidance on the Impact of COVID-19 on Research Funded or Supported by NIHR. http://www.nihr.ac.uk/news/dhsc-issues-guidance-on-the-impact-of-covid-19-on-research-funded-or-supported-by-nihr/24469 (Last accessed: 25 November 2021.)
  5. Shiely F, Foley J, Stone A et al (2021) Managing clinical trials during COVID-19: experience from a clinical research facility. Trials. 22, 62. doi: 10.1186/s13063-020-05004-8
  6. Singh AG, Chaturvedi P (2020) Clinical trials during COVID-19. Head & Neck. 42, 7, 1516-1518. doi: 10.1002/hed.26223
  7. Wang C, Horby PW, Hayden FG et al (2020) A novel coronavirus outbreak of global health concern. The Lancet. 395, 10223, 470-473. doi: 10.1016/S0140-6736(20)30185-9
  8. Weiner DL, Balasubramaniam V, Shah SI et al (2020) COVID-19 impact on research, lessons learned from COVID-19 research, implications for pediatric research. Pediatric Research. 88, 148-150. doi: 10.1038/s41390-020-1006-3
  9. World Health Organization (2020a) Statement on the Second Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Outbreak of Novel Coronavirus (2019-Ncov). http://who.int/news/item/30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-outbreak-of-novel-coronavirus-(2019-ncov) (Last accessed: 25 November 2021.)
  10. World Health Organization (2020b) WHO Director-General’s Opening Remarks at the Media Briefing on COVID-19 – 11 March 2020. http://who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020 (Last accessed: 25 November 2021.)
  11. World Health Organization (2021) Weekly epidemiological update on COVID-19 – 23 November 2021. http://www.who.int/publications/m/item/weekly-epidemiological-update-on-covid-19---23-november-2021 (Last accessed: 25 November 2021.)

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