Recruitment, Recruitment, Recruitment – But Do We Collect and Report All The Information We Should? A Retrospective Review of Ovarian Cancer Trials in A 10-Year Period

doi:10.21203/rs.3.rs-1121888/v1

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Recruitment, Recruitment, Recruitment – But Do We Collect and Report All The Information We Should? A Retrospective Review of Ovarian Cancer Trials in A 10-Year Period

https://doi.org/10.21203/rs.3.rs-1121888/v1

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Background

Achieving recruitment targets is a challenge to every clinical trial’s success. Evidence suggests that the recruiter has an impact on a patient's decision to participate in a clinical trial but there is no evidence that it improves recruitment rates. The aim of this study was to determine if the person who recruits the participants to the trial impacts recruitment timelines and targets. We chose ovarian cancer clinical trials to test this. A secondary outcome was to identify if trialists published their recruitment strategies.

Methods

We identified a body of ovarian cancer (OC) clinical trials between 2010 and 2021. Searches were conducted in CINAHL, PubMed, Medline (OVID and EBSCO) and separately in the New England Journal of Medicine, American Cancer Society Journals, Lancet Oncology, Journal of Clinical Oncology and BMC Cancer. We also identified all associated protocols or supplementary material associated with each trial. We reviewed 139 papers, 30 protocols, 105 registry entries and 26 trial websites associated with 88 phase III OC trials.

Results

Of the 88 trials, only 31% (n=28) made reference to the recruiter but this was reported only in the protocol so we have no evidence these named recruiters performed the task. Seventy-nine trials were registered on a clinical trial registry, but only 11 (14%) of these included a protocol. None of the trials reviewed published a recruitment strategy or made reference to an available recruitment strategy for the trial. None of the trials reviewed which closed early, or extended recruitment timelines due to slow accrual, reported measures taken to improve recruitment rates before stoppages or changes took place. There were disparities in the reported target recruitment numbers between the protocol, the publication and the registry.

Conclusions

Trialists need to think carefully about the trial data they collect, the reasons for collection and who the data collection is for. They also need to increase the transparency of their practices. We believe the inclusion of a patient or member of the public at the design phase of the trial would assist this focus.

Trial methodology

recruitment

recruitment strategies

ovarian cancer trials.

Randomised controlled trials (RCT) are effective for determining intervention efficacy¹. However, it is well documented that recruitment is a significant challenge to the success of any clinical trial^2–7. Approximately 80% of clinical trials fail to recruit to their initial timeline and targets, a figure which highlights the challenge for clinical trialists globally^{6, 8}. Failure to recruit sufficiently has resounding financial and ethical implications^{5, 9, 10}. Multiple methodological interventions have been trialled such as financial incentives¹¹, multimedia programmes^{1, 12–15}, decision aids^16–18, follow up reminders^{19, 20}, optimised or modified trial information documents²¹ and bespoke assessment and feedback on specific recruitment processes^22–24. Some have improved recruitment, but none very significantly.

Some evidence suggests that the recruiter has an impact on a patient’s decision to participate in a clinical trial^25–28. However, there is no evidence that it improves overall recruitment rates. We do know that “trust in the doctor” is frequently cited as a reason for trial participation^29–32 and good communication, listening and interpersonal skills- termed 'alliance building'- is reported to influence a patient’s confidence and trust in their doctor^{26, 29, 33}. Effective alliance building, such as offering support and addressing patient concerns, led to increased confidence in the doctor, trust in the treatment decision and higher clinical trial acceptance^{26, 31, 32, 34–38}. The presence of this relationship prior to trial invitation coupled with enthusiasm shown for the trial is seen throughout the literature as a facilitator for trial acceptance^{9, 26, 35, 39, 40}. However, who recruits the participant and the impact this has on successful trial recruitment and meeting recruitment timelines is not well understood. Thus, the purpose of this study was to determine if the person who recruits the participants to the trial impacts the recruitment timelines and targets. We chose ovarian cancer (OC) clinical trials to investigate our research question and test our hypothesis. The secondary outcome was to identify the number of OC clinical trials that published their recruitment strategies.

A retrospective review of OC RCTs was conducted. The work had four stages.

1. Identify a body of OC trials (2010-2021)

2. Identify protocols or supplementary material associated with each trial

3. Extract the data

4. Analyse the data to fulfil our outcomes for the study

Stage 1 – Identify a body of ovarian cancer trials (2010-2021)

The following databases were searched for eligible studies, CINAHL, MEDLINE (Ovid and EBSCO) and PubMed. An example of a search strategy for CINAHL can be seen in Supplementary File 1. The following high impact journals were also reviewed for suitable studies: New England Journal of Medicine, American Cancer Society Journals, Lancet Oncology, Journal of Clinical Oncology and BMC Cancer. Clinicaltrials.gov was then searched to capture any remaining OC trials not already identified.

The eligibility criteria for trials were:

The trial was an OC clinical trial,
The trial was Phase 3,
The trial was not actively recruiting,
The trial results were published from 2010 to 2021,
The trial could be industry or academic led
The trial was published in English
The Full text was available for inclusion.

We anticipated fewer OC studies than for example, breast cancer, so we selected a 10-year review period and set ourselves a target of 50 trials. We wanted the sample to be large enough to say something meaningful, but not so large that it could not be completed in a 3-month window - the timeframe allocated to complete this work as an MSc dissertation for a taught programme MSc Clinical Trials. 225 published articles were identified through title and abstract review and saved to Zotero reference manager. Duplicates were removed, leaving a total of 156 articles. Trials often published several articles reporting different elements of the same trial. These articles were grouped together per trial, leaving a total of 97 trials (from 156 articles). Nine trials (and 17 published articles) were deemed ineligible on full text review. Eighty-eight OC trials, consisting of 139 published articles and conference abstracts were included. Thus we included all OC trials meeting our eligibility criteria in a 10-year period, representing a complete and unbiased sample. Figure 1 shows the flow chart of the included studies.

Stage 2: Identify protocols or supplementary material associated with each trial

EOSG searched trial registries (clinicaltrials.gov, EudraCT, ISRCTN and UMIN) for available protocols and supplementary information. Additionally, all published journal articles were reviewed to check for supplementary material. The name of each trial was put into a search engine and associated trial website were located and examined for suitable material. In total, 139 articles of OC trials, 40 protocols, 105 trial registries and 26 trial websites were reviewed. 88 trials were included in this study.

Stage 3: Extract the data

The data extraction sheet (Supplementary File 2) was piloted by EOSG on five trials to ensure full data extraction would be achieved for the outcomes of interest. This was reviewed by FS and any disagreements were resolved by discussion. EOSG conducted the remaining data extraction. Quantitative data on recruitment numbers, recruitment timelines and sample sizes were recorded. Qualitative data included the reasons given for challenges or insufficient recruitment, documented recruitment aids and descriptions of the recruiter.

Stage 4: Analyse the data to fulfil our outcomes for the study

Analysis was simple – we reported on the presence or absence of an identified recruiter and we recorded any details on who recruited the participants. We reported on trial sample size, recruitment targets and recruitment achieved in both the protocol and the associated publication.

The recruiter and locating the information

Eighty-eight OC RCTs in both surgical and medical settings met the eligibility criteria. We reviewed 139 papers, 30 protocols, 105 registry entries and 26 trial websites associated with these trials (Supplementary File 3).

Only 31% (n=28) of OC trials made reference to who would be recruiting and consenting the patient to the trial. This information was available in the protocol only. No mention was made of who recruited the participant to the trial in any associated publication, peer-reviewed or otherwise. Twenty-eight 28 studies recorded recruiter description. It varied between studies and often more than one term was used such as the principle investigator (n=6), the investigator (n=16), the delegate (n=8), the surgeon (n=1) or the investigator who regularly treats the target population (n=1). Only one trial outlined the pathway for recruitment to the trial in the protocol - the consultant gynaecologist introduced the study and the consultant radiation oncologist recruited the patient to the study (60).

While 89% (n=79) of trials included in this review were registered on at least 1 clinical trial registry, only 11 (14%) of those registered included a protocol on the registry. We had to delve further into the literature to locate other protocols published as supplementary information with a journal publication. Overall, only 45% (n = 40) of trials had published protocols available to review and these were in clinicaltrials.gov registry (n=11) and as supplementary information as part of the publication in two journals, NEJM and the Lancet (n=29). Eleven of these protocols were heavily redacted.

Recruitment strategy

None of the trials reviewed published a recruitment strategy or made reference to an available recruitment strategy for the trial. Only two trials made specific reference to advertisements and hospital databases as sources of recruitment in the protocol. Seven (8%) studies referred to the opening of additional sites if recruitment was slow, and the closure of slow recruiting sites in the published protocol, but did not report this as a recruitment strategy.

60% of trials made reference to when recruitment would take place. This was described in general terms such as “prior to study registration” or “before study procedures take place”. None of the trials reported where recruitment took place. 29% reported the use of aids to assist recruitment, but these aids were reported as informed consent documents or procedures (patient information leaflets, informed consent forms and oral explanation), essential documents already mandated for use in clinical trials. None of the trials reported the use of any other recruitment aids or specialised strategies for recruitment. Two trials had trial websites with a section for patients available and one trial had newsletters available on the trial website but these were not reported as a recruitment strategy in the protocols or published journal articles. It was unclear if these were passively available to patients or if patients were actively encouraged to engage with these materials.

Trial sample size and accuracy of reporting

Ninety-eight per-cent of all clinical trials reviewed stated their required sample size for the study and 100% reported the actual enrolment figure in the journal articles. However, in 6 studies, there were differences in the reported target recruitment numbers between the protocol, the publication and the registry. Similarly, differences were noted in achieved samples sizes of 8 studies (Table 1). Causes for these differences were not reported in any associated publications reviewed.

Table 1

Differences in reporting targeted and achieved sample size
Trial	Target sample size- protocol	Target sample size- clinicaltrials.gov	Target sample size- publication	Achieved sample size- clinicaltrials.gov	Achieved sample size- Publication
Moore et al., 2018 (Solo1)	344	347	206 events	450	391
Walker et al., 2019 (GOG-252)	N/A	1100	1500	1560	1560
Pignata et al., 2011 (MITO-2)	N/A	530	820	820	820
Fotopoulou et al., 2014 (OVATURE)	N/A	470	340	142	142
de Boer et al., 2018 (PORTEC-3)	670	800	670	670	686
Mahner et al., 2017 (TRUST)	N/A	686	772	797	772
Vergote et al., 2010 (ASSIST-5)	N/A	224	224	244	125
van Driel et al., 2018 (HIPEC)	240	280	245	242	245
Moore and Pignata, 2019 (GOG3015)	N/A	1300	N/A	1278	1301
Monk et al., 2020 (MILO)	N/A	300	360	341	303
Oza et al., 2017 (ROSIA)	N/A	1000	NR	1021	1021
Fagotti et al., 2016 (SCORPION)	N/A	110	110	171	110
Moore et al., 2018 (Forward 1)	333	247	333	366	366
Pujade-Lauraine et al., 2017 (SOLO 2)	N/A	264	192	337	295
NR= not reported N/A= not available

Ninety-five percent (n=84) of trials reported the achieved recruitment timelines in an academic journal article although this was always reported from first patient randomised to last patient randomised, not time of opening to recruitment to time of closing to recruitment.

Only 67% (n=59) of all included trials reported both the planned recruitment timeline and the actual recruitment timeline in an academic journal article. 26% (n=15/59) of these recruited for longer than planned and more than half of those (n = 8) did so without reporting any reasons for the extended accrual period. Six of the trials reported 'recruitment challenges', but provided no further detail on what those challenges were. Finally, one trial explicitly reported receiving a recruitment period extension⁴¹.

Fourteen per cent (13/88) of included trials were suspended, withdrawn or terminated earlier than expected. A variety of reasons were reported, often more than one, however six trials cited poor or slow accrual as the reason for closure (Figure 2).

Seventy-seven percent (n=46/59) of trials, for which information was available, recruited on target and on time. None of these trials reported the recruitment measures used to reach these targets. None of the trials which closed or extended recruitment timelines due to slow accrual reported measures taken to improve recruitment rates before stoppages or changes took place.

Our study has highlighted some deficits in data collection and data reporting in clinical trials. We examined all trials in one clinical area for a 10-year period and were unable to determine who recruited the participants. Of course, in order for it to be reported, it needs to be collected, and we cannot determine if this was the case. We can see from the protocols of 31% of trials that there was a plan in place for who would be recruiting participants but given that there was no information in the associated published papers for these trials, it is unclear if the proposed recruitment strategy was actually followed during the trial. For the reasons highlighted in our background, i.e., participants actually have a preference for who recruits them to a trial, we think our findings at a minimum are important to give trial teams some pause for thought.

Trust in the doctor and the institution is one of the most frequently cited facilitators for clinical trial participation, yet there are few interventions published that aim to address this and assess its effect on recruitment rates^{26, 29, 33}). The most successful to date is the Quintet Recruitment Intervention (QRI)^{22, 24, 40, 42} but this focuses mainly on the discussion between the patient and doctor rather than who the recruiter is or alliance building between the two. Further studies are recommended to address this knowledge gap.

An interesting incidental finding of this study is that there is some disparity in reporting of recruitment figures between different resources, for example, between the article and the trial registry as shown in Table 1. There could be several reasons for this: 1. the registry is incorrectly updated, possibly due to human error; 2. the most recent protocol version may not be published and therefore the information available could be out-dated; 3.it could be that the registry lists the “actual enrolment figure” which could be interpreted in different ways. It could be interpreted as the number of patients who signed consent or the number who proceeded to the treatment phase. This disparity in reporting is misleading for researchers, patients and the public alike. OC clinical trials have vastly varying screen failure rates. This is due to disease burden, an increasing number of biomarker led studies and narrow inclusion criteria^{43, 44}. Not every patient who signs consent is eligible to proceed to the treatment phase. Therefore, it is essential that the term “actual enrolment figure” is clarified when trials are reported and clearly outlines whether it refers to the number of patients who signed consent or the number who proceeded to the treatment phase.

We live in an era where we are more aware of accessibility, inclusion for all and open access. Participants in trials should be able to access all trial documentation, if they are freely giving their time and commitment to a trial. There should be total transparency and no illusion of lack of transparency. Unintended or not, we have shown here that only 14% of the 79 registered trials published the trial protocol on the registry. It should be common practice that the protocol and all its amendments are published.

No OC trials published a recruitment strategy, a similar finding to previous studies^{10, 45–47}. This contradicts the recommendations of item 15 of the SPIRIT statement⁴⁸. However, there is evidence that recruitment strategies were used during the trials. For example, some trials were found to have trial websites with specific sections for patients but did not report these in the published literature. Thus, no information exists as to how effective this resource is as a decision aid for patients and a recruitment tool for the trial. Poor reporting of strategies and timelines has led to a missed opportunity to identify effective trial efficiencies. Publication of detailed recruitment strategies should be a requirement of the CONSORT statement as an expansion of sections 4b and 14a⁴⁹ to guide further methodological research.

This study focused on one clinical area, OC trials but it included all trials for the last 10 years. We don't believe our findings would be any different if we had tested our hypothesis on a different clinical area. Trialists need to think carefully about the trial data they collect, the reasons for collection and who the data collection is for. We believe the inclusion of a patient or member of the public at the design phase of the trial would assist this focus. Recruitment strategies exist, and we are sure most trial centres use recruitment strategies, but they need to be reported, so we can evaluate their effectiveness. To not do this is wasteful. In short, we need more thought about open access, visibility of trial conduct and better reporting.

Ethics approval and consent to participate

This was a retrospective study of existing publically available research therefore ethical approval was not required.

Consent for publication

Not applicable.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing interests

The authors declare that they have no competing interests.

Funding

There was no funding received for this research.

Authors' contributions

EOSG undertook this research project in part-fulfilment of her MSc Clinical Trials. FS conceptualised the research project, supervised the research and commented on multiple drafts.

Acknowledgements

None

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Recruitment, Recruitment, Recruitment – But Do We Collect and Report All The Information We Should? A Retrospective Review of Ovarian Cancer Trials in A 10-Year Period

Status:

Version 1

Abstract

Background

Methods

Results

Conclusions

Figures

Background

Methods

Stage 1 – Identify a body of ovarian cancer trials (2010-2021)

Stage 2: Identify protocols or supplementary material associated with each trial

Stage 3: Extract the data

Stage 4: Analyse the data to fulfil our outcomes for the study

Results

The recruiter and locating the information

Recruitment strategy

Trial sample size and accuracy of reporting

Discussion

Conclusion

Declarations

References

Supplementary Files

Status:

Version 1