Determinants of patient recruitment in a multicenter clinical trials group: trends, seasonality and the effect of large studies
Open accessAbstract
BACKGROUND: We examined whether quarterly patient enrollment in a large multicenter clinical trials group could be modeled in terms of predictors including time parameters (such as long-term trends and seasonality), the effect of large trials and the number of new studies launched each quarter. We used the database of all clinical studies launched by the AIDS Clinical Trials Group (ACTG) between October 1986 and November 1999. Analyses were performed in two datasets: one included all studies and substudies (n = 475, total enrollment 69,992 patients) and the other included only main studies (n = 352, total enrollment 57,563 patients). RESULTS: Enrollment differed across different months of the year with peaks in spring and late fall. Enrollment accelerated over time (+27 patients per quarter for all studies and +16 patients per quarter for the main studies, p < 0.001) and was affected by the performance of large studies with target sample size > 1,000 (p < 0.001). These relationships remained significant in multivariate autoregressive modeling. A time series based on enrollment during the first 32 quarters could forecast adequately the remaining 21 quarters. CONCLUSIONS: The fate and popularity of large trials may determine the overall recruitment of multicenter groups. Modeling of enrollment rates may be used to comprehend long-term patterns and to perform future strategic planning.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Enrollment trend analysis provides insights to strengthen promotional strategies and program visibility.
“Enrollment trend analysis also provides insights to strengthen promotional strategies and program visibility (Haidich & Ioannidis, 2001;Hardinger et al., 2015).”
From Data-Driven Decision-Making through Real-time Student Progress Monitoring: Academic Administrators Perspectives (2025) · cites this paper as Haidich & Ioannidis, 2001
The Abstract’s Conclusions and the Discussion say that analyzing enrollment trends can inform strategic planning for a multicenter clinical trials group. They do not connect that analysis to strengthening promotional strategies or program visibility. (LLM, conf=0.86)
Experimental — accuracy not yet measured
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Large Trials vs Meta-analysis of Smaller Trials: How Do Their Results Compare?
Cappelleri, J. C. (1996) · JAMA · doi:10.1001/jama.1996.03540160054033 · Cited by 336 · see citing works
Flagged first, then by citations
Research works printed but not linked: 15
- Haidich A-B Ioannidis JPA Patterns of patient enrollment in randomized controlled trials. J Clin Epidemiol 11520646
- Hammer SM Squires KE Hughes MD Grimes JM Demeter LM Currier JS Eron JJ Jr Feinberg JE Balfour HH Jr Deyton LR A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. N Engl J Med 1997 337 725 33 9287227 10.1056/NEJM199709113371101 · DOI
- Peto R Collins R Sackett D Darbyshire J Babiker A Buyse M Stewart H Baum M Goldhirsch A Bonadonna G The trials of Dr. Bernard Fisher: a European perspective on an American episode. Control Clin Trials 1997 18 1 13 9055048 10.1016/S0197-2456(96)00225-5 · DOI
- Rosendorf LL Dafni U Amato DA Lunghofer B Bartlett JG Leedom JM Wara DW Armstrong JA Godfrey E Sukkesstad Performance evaluation in multicenter clinical trials: development of a model by the AIDS Clinical Trials Group. Control Clin Trials 1993 14 523 537 8119067 10.1016/0197-2456(93)90032-9 · DOI
- Sylvester RJ Pinedo HM De Pauw M Staquet MJ Buyse ME Renard J Bonadonna G Quality of institutional participation in multicenter clinical trials. N Engl J Med 1981 305 852 855 7278884
- Carew BD Ahn SA Boichot HD Dierenfeldt BJ Dolan NA Edens TR Weiner DH Probstfield JL Recruitment strategies in the studies of left ventricular dysfunction (SOLVD): strategies for screening and enrollment in two concurrent, but separate trials. The SOLVD Investigators. Control Clin Trials 1992 13 325 338 1330437 10.1016/0197-2456(92)90035-X · DOI
- Shea S Bigger JT Jr Campion J Fleiss JL Rolnitzky LM Schron E Gorkin L Handshaw K Kinney MR Branyon M Enrollment in clinical trials: institutional factors affecting enrollment in the cardiac arrhythmia suppression trial (CAST). Control Clin Trials 1992 13 466 486 1334819 10.1016/0197-2456(92)90204-D · DOI
- Ling J Rees E Hardy J What influences participation in clinical trials in palliative care in a cancer centre? Eur J Cancer 2000 36 621 626 10738127 10.1016/S0959-8049(99)00330-5 · DOI
- Hawkins BS Prior MJ Fisher MR Blackhurst DW Relationship between rate of patient enrollment and quality of clinical center performance in two multicenter trials in ophthalmology. Control Clin Trials 1990 11 374 394 1963130 10.1016/0197-2456(90)90177-4 · DOI
- Kaluzny AD Lacey LM Warnecke R Hynes DM Morrissey J Ford L Sondik E Predicting the performance of a strategic alliance: an analysis of the Community Clinical Oncology Program. Health Serv Res 1993 28 159 182 8514498 PMC1069928
- Cotton DJ Finkelstein DM He W Feinberg J Determinants of accrual of women to a large, multicenter clinical trials program of human immunodeficiency virus infection. The AIDS Clinical Trials Group. J Acquir Immune Defic Syndr 1993 6 1322 1328 8254470
- Ioannidis JPA Bassett R Hughes MD Vorberding PA Sacks HS Lau J Predictors and impact of patients lost to follow-up in a long-term trial of early versus deferred antiretroviral treatment. J Acquir Immune Defic Syndr Human Retrovirol 1997 16 22 30 9377121
- Detsky AS Using cost-effectiveness analysis to improve the efficiency of allocating funds to clinical trials. Stat Med 1990 9 173 84 2111932
- Detsky AS Are clinical trials a cost-effective investment? JAMA 1989 262 1795 800 2506366 10.1001/jama.262.13.1795 · DOI
- Ioannidis JPA Cappelleri JC Lau J Issues in comparisons between meta-analyses and large trials. JAMA 1998 279 1089 93 9546568 10.1001/jama.279.14.1089 · DOI
Cited by
Sorted by citations
McGill, K., Sackley, C., Godwin, J., Gavaghan, D., Ali, M., Ballester, B. R., Brady, M. C., Brady, M. C., Ali, M., Ashburn, A., et al. (2022) · Journal of Stroke and Cerebrovascular Diseases · doi:10.1016/j.jstrokecerebrovasdis.2021.106229 · Cited by 14 · see citing works
Secreto, P. V., Ofrin, D., & Tabo, E. (2025) · International Journal in Information Technology in Governance, Education and Business · doi:10.32664/ijitgeb.v7i1.147 · Cited by 2 · see citing works
“Enrollment trend analysis also provides insights to strengthen promotional strategies and program visibility (Haidich & Ioannidis, 2001; Hardinger et al., 2015).”
- Authors
- Haidich, A.-B., & Ioannidis, J. P.
- Affiliations
- University of Ioannina (GR)
- Tufts University (US)
- Corresponding author
- Haidich, Anna-Bettina
- Venue
- BMC Medical Research Methodology
- Published
- 2001-06-08
- Volume
- 1
- Issue
- 1
- Pages
- 4-4
- ISSN
- 1471-2288 (ISSN-L)
- PMC
- PMC33393
- OpenAlex
- W1962297384
- Cited by
- 34
- References
- 1
- Citations by year
- 2025: 1 · 2024: 2 · 2023: 1 · 2022: 1 · 2021: 2 · 2020: 4 · 2019: 1 · 2018: 1 · 2017: 2 · 2016: 2 · 2015: 2 · 2014: 4 · 2013: 1 · 2012: 2
- FWCI
- 0.39
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Medical Research Methodology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, other-oa)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- ACT Government
- General Secretariat for Research and Technology
- National Institutes of Health
- National Institute of Allergy and Infectious Diseases
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health and Medical Research Impacts
- Keywords
- patient recruitment, AIDS Clinical Trials Group, enrollment trends, seasonal variation, trial size, time series forecasting, multivariate autoregressive modeling, strategic planning
- MeSH terms
- Clinical Trials as Topic, Evaluation Studies as Topic, Humans, Predictive Value of Tests, Regression Analysis, Seasons, Time, Models, Statistical, Multicenter Studies as Topic, Epidemiologic Factors, Multivariate Analysis, Patient Selection
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
