Assessing the challenges of multi‐scope clinical research sites: an example from NIH HIV/AIDS clinical trials networks

Abstract

Rationale, aims, and objectives Large-scale, multi-network clinical trials are seen as a means for efficient and effective utilization of resources with greater responsiveness to new discoveries. Formal structures instituted within the National Institutes of Health (NIH) HIV/AIDS Clinical Trials facilitate collaboration and coordination across networks and emphasize an integrated approach to HIV/AIDS vaccine, prevention, and therapeutics clinical trials. This study examines the joint usage of clinical research sites as means of gaining efficiency, extending capacity, and adding scientific value to the networks. Methods A semi-structured questionnaire covering 8 clinical management domains was administered to 74 (62% of sites) clinical site coordinators at single- and multi-network sites to identify challenges and efficiencies related to clinical trials management activities and coordination with multi-network units. Results Overall, respondents at multi-network sites did not report more challenges than single-network sites, but did report unique challenges to overcome including in the areas of study prioritization, community engagement, staff education and training, and policies and procedures. The majority of multi-network sites reported that such affiliations do allow for the consolidation and cost-sharing of research functions. Suggestions for increasing the efficiency or performance of multi-network sites included streamlining standards and requirements, consolidating protocol activation methods, using a single cross-network coordinating center, and creating common budget and payment mechanisms. Conclusions The results of this assessment provide important information to consider in the design and management of multi-network configurations for the NIH HIV/AIDS Clinical Trials Networks, as well as others contemplating and promoting the concept of multi-network settings.

Stakeholder engagement to informHIVclinical trials: a systematic review of the evidence

“…In contrast, fewer studies conducted stakeholder engagement in middle‐ (30 studies; 27.8%) 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100 and low‐income (nine studies; 8.3%) 101, 102, 103, 104, 105, 106, 107, 108, 109 countries. The location of stakeholder engagement could not be discerned in six studies (5.6%) 110, 111, 112, 113, 114, 115, and fifteen studies (13.9%) 16, 24, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128 conducted stakeholder engagement in multiple countries at different income levels.…”

“…In contrast, fewer studies conducted stakeholder engagement in middle-(30 studies; 27.8%) and low-income (nine studies; 8.3%) [101][102][103][104][105][106][107][108][109] countries. The location of stakeholder engagement could not be discerned in six studies (5.6%) [110][111][112][113][114][115], and fifteen studies (13.9%) [16,24,[116][117][118][119][120][121][122][123][124][125][126][127][128] conducted stakeholder engagement in multiple countries at different income levels.…”

Seven-Year Experience From the National Institute of Neurological Disorders and Stroke–Supported Network for Excellence in Neuroscience Clinical Trials

“…Recruitment of participants, including under represented populations, and retention of participants are considered challenges in most fields 6 but can be particularly complex in neurologic disorders. Slow enrollment can increase study costs or lead to inconclusive results if there is incomplete accrual.…”

“…By facilitating collaboration, capacity, and training, trial networks can expedite therapy development. 6 A successful federally supported network, Neurological Emergencies Treatment Trials, conducting phase III randomized clinical trials began in 2007. 7 Master clinical trial agreements (MCTA) were used, but the environment was not ripe for central institutional review boards (cIRB).…”

Clinical trials site recruitment optimisation: Guidance from Clinical Trials: Impact and Quality

“…This was supported by previous reports that when staff do not view clinical trials as an essential business activity, it can create a detached research culture, and can adversely impact recruitment outcomes. 10,13,14 As previously highlighted, an adequate recruitment budget is essential to recruitment success, but having low-cost recruitment options are also important where budget may be limited, and this was included in the recommendations developed.…”