Key challenges | Solutions | Future implications |
---|---|---|
1) Identification of centres willing/able to participate in the study | ||
• Identifying centres with interest/capacity to participate in research and the correct people to discuss participation with proved difficult via conventional means (unsolicited mail/email). • Limitations in dedicating time or resources to external research projects due to clinical workloads and lack of designated support staff were common reasons for non-participation cited by centres. Levels of remuneration provided to centres for participation in the study were considered insufficient by some centres. • Availability of NHS staff participating in research having completed Good Clinical Practice (GCP) training. | • The ZQOL study was accepted into the National Institute for Health Research Clinical Research Network (NIHR CRN) portfolio. NIHR were able to offer wide range of support services including: o Access to existing networks of centres with interests in participating in research. o Provision of support to centres interesting in participating in research. o Exploring centre eligibility for additional remuneration for participation in NIHR CRN-approved studies. o Delivering GCP training to centres interesting in participating in studies. | • Experiences indicate the need for greater links between commissioners of research and primary/secondary care centres. • A refocusing of targets for primary care centres, to provide staff with opportunities and incentives for partaking in research is needed. • Current R&D approval process makes no concessions for non-interventional research. R&D requirements should be proportionate to the risks associated with patient participation in such studies. |
2) Obtaining Ethics and Research & Development (R&D) Management Approval | ||
• Information and documentation required to support R&D applications was a barrier to participation for a number of centres. • Significant variation in timelines for R&D approval at a local and regional level (i.e. England, Scotland, Wales & Northern Ireland) led to significant delays in the study. • R&D approval process requires that extensive tri-partite agreements between the study sponsor, co-ordinating CRO and R&D department be agreed and signed. However, there is no standard template available for such agreements. | • ZQOL study organisers implemented a number of practical solutions including: o Minimising the number of R&D approvals by seeking participation of clusters of centres in the same NHS trust. o Implemented a staged study roll-out such that R&D applications for key centres were prioritised and R&D applications could occur in parallel to patient recruitment. • NIHR CRN can also provide assistance: o As a NIHR-CRN portfolio adopted study, more likely to be considered for priority review by R&D depts. o NIHR CRN local research network teams are able to offer support and guidance to co-ordinating CROs throughout England. | • Current R&D approval process makes no concessions for non-interventional research. R&D requirements should be proportionate to the risks associated with patient participation in such studies. • A move to standardise R&D approval process across NHS trusts in England would reduce burden (and barriers) to research for study organisers and NHS staff interested in participating in research. |
3) Recruitment of Study Participants | ||
• Recruitment of HZ patients in primary care was slower than envisaged, a likely result of practical and organisational factors: o As an acute condition, HZ patients had to be recruited on initial presentation to physicians and did not allow searches of eligible participants via patient medical records. o At the time of the study there will only limited opportunities for notifications and reminders to be incorporated into electronic-record systems on presentation of incident cases. • Lack of unique identifiers or codes in electronic-record systems made it difficult to identify PHN patients for participation in the ZQOL study. | • To ensure that study recruitment quotas were met, additional centres were recruited for participation in the study and study timelines were extended. • NIHR CRN local research networks and the co-ordinating CRO were in regular contact with centre staff so to ensure to provide support where needed. | • Standardisation of medical record keeping and greater integration of record and monitoring systems would be to the benefit of facilitating real-world research. • Centres having systems in place to confirm the feasibility of recruitment numbers and having opportunity to work alongside study organisers could facilitate the development of study inclusion/exclusion criteria that are less restrictive to recruitment in real-world practice. |