Non-commercial trials that fail to meet their targets often result in a request for further funding or may not achieve a statistically significant result. It is important to ensure that feasibility assessment and recruitment planning are considered during the study design and planning stage of a trial. For larger trials, the sponsor should consider, during the funding process, whether a feasibility or pilot study should be undertaken.
The Association of Medical Research Charities and the NIHR Medicines for Children Research Network have produced Points to consider when assessing the feasibility of research. The US Clinical Trials Transformation Initiative (CTTI) have published a suite of Recommendations and Tools for Recruitment Planning that provide a useful framework.
MRC Hubs for Trial Methodology Research (MRC HTMR)
The MRC HTMR have published a range of material relating to feasibility and recruitment including:
- Guidance on maximising the impact of qualitative research in feasibility studies for RCTs was developed to help researchers consider the full range of contributions that qualitative research can make in relation to their particular trial.
- The QuinteT Recruitment Intervention (QRI) provides a flexible way of understanding recruitment difficulties and producing a plan to address them while ensuring engaged and well-informed decision making by patients. A review of qualitative research provides further insights into barriers to recruitment.
- A broad range of Tips to consider when optimising recruitment of patients to clinical trials has been produced by the Recruitment Working Group of the MRC HTMR.
- This review and synthesis of qualitative research examining the perspectives of patients and health professionals provides a conceptual framework to help researchers improve recruitment to depression trials.
For multi-site trials, the careful selection and evaluation of investigator sites is critical for the successful completion of a trial within budget, timelines and to ensure the generation of high quality data. Factors that should influence investigator site selection include:
- Interest in the research question
- Experience and qualifications of the investigator
- Sufficient staff to conduct the study and their experience and qualifications
- Availability of suitable patient population:
- Anticipated rate of patient recruitment (determined through feasibility assessments)
- Conflicting studies (competing for the patient population and potentially introducing recruitment bias)
- Adequate time to conduct and oversee the trial
- Adequate facilities:
- Availability of any specialised diagnostic or therapeutic equipment required by the protocol
- Adequate space and storage conditions (including archive)
- Available resources in NHS support departments
- Track record with similar trials previously
- Geographic location
- Contractual and budgetary negotiations and arrangements.
When undertaking site selection, the preparation of ‘reserve’ investigator sites (so that the trial may be extended to these sites if recruitment issues arise) should be considered as part of proactive trial planning.
Patient and Public Involvement (PPI):
The CTTI recommendations above stress the importance of patient and public engagement to improve trial success. The initiative includes a Stakeholder Identification and Analysis Tool to support this process. One study from King’s College London, published in the British Journal of Psychiatry showed that trials with higher levels of PPI were 4.12 times more likely to recruit to target. PPI can help shape a number of factors that can improve trial feasibility and recruitment by addressing questions such as:
- Will the proposed recruitment strategy work?
- How could it be made easier for a patient to participate?
- How likely are participants going to accept the study schedule/requirements?
- UK Clinical Trial Gateway provides potential research participants with information about trials running in the UK, including how to locate and contact trials of interest.
- Frequently Asked Questions on Data Requirements on Performance in initiating and Delivering Clinical Research – An NIHR document explaining the importance of recruitment on time and target.