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Published in: Systematic Reviews 1/2024

Open Access 01-12-2024 | Systematic review update

The usage of population and disease registries as pre-screening tools for clinical trials, a systematic review

Authors: Juliette Foucher, Louisa Azizi, Linn Öijerstedt, Ulf Kläppe, Caroline Ingre

Published in: Systematic Reviews | Issue 1/2024

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Abstract

Objective

This systematic review aims to outline the use of population and disease registries for clinical trial pre-screening.

Materials and methods

The search was conducted in the time period of January 2014 to December 2022 in three databases: MEDLINE, Embase, and Web of Science Core Collection. References were screened using the Rayyan software, firstly based on titles and abstracts only, and secondly through full text review. Quality of the included studies was assessed using the List of Included Studies and quality Assurance in Review tool, enabling inclusion of publications of only moderate to high quality.

Results

The search originally identified 1430 citations, but only 24 studies were included, reporting the use of population and/or disease registries for trial pre-screening. Nine disease domains were represented, with 54% of studies using registries based in the USA, and 62.5% of the studies using national registries. Half of the studies reported usage for drug trials, and over 478,679 patients were identified through registries in this review. Main advantages of the pre-screening methodology were reduced financial burden and time reduction.

Discussion and conclusion

The use of registries for trial pre-screening increases reproducibility of the pre-screening process across trials and sites, allowing for implementation and improvement of a quality assurance process. Pre-screening strategies seem under-reported, and we encourage more trials to use and describe their pre-screening processes, as there is a need for standardized methodological guidelines.
Appendix
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Literature
2.
go back to reference Su Q, Cheng G, Huang J. A review of research on eligibility criteria for clinical trials. Clin Exp Med. 2023;23:1867–79.PubMedCrossRef Su Q, Cheng G, Huang J. A review of research on eligibility criteria for clinical trials. Clin Exp Med. 2023;23:1867–79.PubMedCrossRef
3.
go back to reference Miesbach W, Oldenburg J, Klamroth R, et al. Gentherapie der Hämophilie: Empfehlung der Gesellschaft für Thrombose- und Hämostaseforschung (GTH). Hamostaseologie. 2023;43:196–207.PubMedCrossRef Miesbach W, Oldenburg J, Klamroth R, et al. Gentherapie der Hämophilie: Empfehlung der Gesellschaft für Thrombose- und Hämostaseforschung (GTH). Hamostaseologie. 2023;43:196–207.PubMedCrossRef
4.
go back to reference Superchi C, Brion Bouvier F, Gerardi C, et al. Study designs for clinical trials applied to personalised medicine: a scoping review. BMJ Open. 2022;12:e052926.PubMedPubMedCentralCrossRef Superchi C, Brion Bouvier F, Gerardi C, et al. Study designs for clinical trials applied to personalised medicine: a scoping review. BMJ Open. 2022;12:e052926.PubMedPubMedCentralCrossRef
5.
go back to reference Chaytow H, Faller KME, Huang Y-T, et al. Spinal muscular atrophy: from approved therapies to future therapeutic targets for personalized medicine. Cell Rep Med. 2021;2:100346.PubMedPubMedCentralCrossRef Chaytow H, Faller KME, Huang Y-T, et al. Spinal muscular atrophy: from approved therapies to future therapeutic targets for personalized medicine. Cell Rep Med. 2021;2:100346.PubMedPubMedCentralCrossRef
6.
go back to reference Sharma R. Innovative genoceuticals in human gene therapy solutions: challenges and safe clinical trials of orphan gene therapy products. CGT. 2024;24:46–72.CrossRef Sharma R. Innovative genoceuticals in human gene therapy solutions: challenges and safe clinical trials of orphan gene therapy products. CGT. 2024;24:46–72.CrossRef
7.
go back to reference Tjeertes J, Bacino CA, Bichell TJ, et al. Enabling endpoint development for interventional clinical trials in individuals with Angelman syndrome: a prospective, longitudinal, observational clinical study (FREESIAS). J Neurodev Disord. 2023;15:22.PubMedPubMedCentralCrossRef Tjeertes J, Bacino CA, Bichell TJ, et al. Enabling endpoint development for interventional clinical trials in individuals with Angelman syndrome: a prospective, longitudinal, observational clinical study (FREESIAS). J Neurodev Disord. 2023;15:22.PubMedPubMedCentralCrossRef
9.
go back to reference Gharat R, Dixit G, Khambete M, et al. Targets, trials and tribulations in Alzheimer therapeutics. Eur J Pharmacol. 2024;962:176230.PubMedCrossRef Gharat R, Dixit G, Khambete M, et al. Targets, trials and tribulations in Alzheimer therapeutics. Eur J Pharmacol. 2024;962:176230.PubMedCrossRef
10.
go back to reference Revelles-Peñas L, Pastor-Navarro S, López-Piñero AA, Velasco-Tirado V. Use of a spinal cord stimulator to treat livedoid vasculopathy: Effective control of an untreatable disease. Estimulador medular en la vasculopatía livedoide: control eficaz de una patología intratable. Actas dermo-sifiliograficas. 2024:S0001-7310(23)00933-X. Advance online publication. https://doi.org/10.1016/j.ad.2023.02.037. Revelles-Peñas L, Pastor-Navarro S, López-Piñero AA, Velasco-Tirado V. Use of a spinal cord stimulator to treat livedoid vasculopathy: Effective control of an untreatable disease. Estimulador medular en la vasculopatía livedoide: control eficaz de una patología intratable. Actas dermo-sifiliograficas. 2024:S0001-7310(23)00933-X. Advance online publication. https://​doi.​org/​10.​1016/​j.​ad.​2023.​02.​037.
11.
go back to reference Goddard-Eckrich D, Gatanaga OS, Thomas BV, et al. Characteristics of drug-involved black women under community supervision; implications for retention in HIV clinical trials and healthcare. Soc Work Health Care. 2024;63:35–52.PubMedCrossRef Goddard-Eckrich D, Gatanaga OS, Thomas BV, et al. Characteristics of drug-involved black women under community supervision; implications for retention in HIV clinical trials and healthcare. Soc Work Health Care. 2024;63:35–52.PubMedCrossRef
12.
go back to reference Chaudhari N, Ravi R, Gogtay N, et al. Recruitment and retention of the participants in clinical trials: challenges and solutions. Perspect Clin Res. 2020;11:64.PubMedPubMedCentralCrossRef Chaudhari N, Ravi R, Gogtay N, et al. Recruitment and retention of the participants in clinical trials: challenges and solutions. Perspect Clin Res. 2020;11:64.PubMedPubMedCentralCrossRef
13.
go back to reference Gul RB, Ali PA. Clinical trials: the challenge of recruitment and retention of participants. J Clin Nurs. 2010;19:227–33.PubMedCrossRef Gul RB, Ali PA. Clinical trials: the challenge of recruitment and retention of participants. J Clin Nurs. 2010;19:227–33.PubMedCrossRef
14.
go back to reference Hadidi N, Lindquist R, Treat-Jacobson D, et al. Participant withdrawal: challenges and practical solutions for recruitment and retention in clinical trials. Creat Nurs. 2013;19:37–41.PubMedCrossRef Hadidi N, Lindquist R, Treat-Jacobson D, et al. Participant withdrawal: challenges and practical solutions for recruitment and retention in clinical trials. Creat Nurs. 2013;19:37–41.PubMedCrossRef
16.
go back to reference Hamel LM, Penner LA, Albrecht TL, et al. Barriers to clinical trial enrollment in racial and ethnic minority patients with cancer. Cancer Control. 2016;23:327–37.PubMedCrossRef Hamel LM, Penner LA, Albrecht TL, et al. Barriers to clinical trial enrollment in racial and ethnic minority patients with cancer. Cancer Control. 2016;23:327–37.PubMedCrossRef
17.
go back to reference Thoma A, Farrokhyar F, McKnight L, et al. Practical tips for surgical research: how to optimize patient recruitment. Can J Surg. 2010;53:205–10.PubMedPubMedCentral Thoma A, Farrokhyar F, McKnight L, et al. Practical tips for surgical research: how to optimize patient recruitment. Can J Surg. 2010;53:205–10.PubMedPubMedCentral
19.
go back to reference on behalf of the INVESTIGATE studies group, Hilton P, Buckley BS, et al. Understanding variations in patient screening and recruitment in a multicentre pilot randomised controlled trial: a vignette-based study. Trials. 2016;17:522.PubMedCentralCrossRef on behalf of the INVESTIGATE studies group, Hilton P, Buckley BS, et al. Understanding variations in patient screening and recruitment in a multicentre pilot randomised controlled trial: a vignette-based study. Trials. 2016;17:522.PubMedCentralCrossRef
21.
22.
go back to reference Mckane A, Sima C, Ramanathan RK, et al. Determinants of patient screen failures in phase 1 clinical trials. Invest New Drugs. 2013;31:774–9.PubMedCrossRef Mckane A, Sima C, Ramanathan RK, et al. Determinants of patient screen failures in phase 1 clinical trials. Invest New Drugs. 2013;31:774–9.PubMedCrossRef
25.
go back to reference Wong SE, North SA, Sweeney CJ, et al. Screen failure rates in contemporary randomized clinical phase II/III therapeutic trials in genitourinary malignancies. Clin Genitourin Cancer. 2018;16:e233–42.CrossRef Wong SE, North SA, Sweeney CJ, et al. Screen failure rates in contemporary randomized clinical phase II/III therapeutic trials in genitourinary malignancies. Clin Genitourin Cancer. 2018;16:e233–42.CrossRef
26.
go back to reference DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ. 2003;22:151–85.PubMedCrossRef DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ. 2003;22:151–85.PubMedCrossRef
27.
go back to reference Lombardo G, Couvert C, Kose M, et al. Electronic health records (EHRs) in clinical research and platform trials: application of the innovative EHR-based methods developed by EU-PEARL. J Biomed Inform. 2023;148:104553.PubMedCrossRef Lombardo G, Couvert C, Kose M, et al. Electronic health records (EHRs) in clinical research and platform trials: application of the innovative EHR-based methods developed by EU-PEARL. J Biomed Inform. 2023;148:104553.PubMedCrossRef
28.
go back to reference Gilmore-Bykovskyi AL, Jin Y, Gleason C, et al. Recruitment and retention of underrepresented populations in Alzheimer’s disease research: a systematic review. A&D Transl Res & Clin Interv. 2019;5:751–70.CrossRef Gilmore-Bykovskyi AL, Jin Y, Gleason C, et al. Recruitment and retention of underrepresented populations in Alzheimer’s disease research: a systematic review. A&D Transl Res & Clin Interv. 2019;5:751–70.CrossRef
29.
go back to reference Task Force Participants, Vellas B, Hampel H, et al. Alzheimer’s disease therapeutic trials: EU/US task force report on recruitment, retention, and methodology. J Nutr Health Aging. 2012;16:339–45.CrossRef Task Force Participants, Vellas B, Hampel H, et al. Alzheimer’s disease therapeutic trials: EU/US task force report on recruitment, retention, and methodology. J Nutr Health Aging. 2012;16:339–45.CrossRef
30.
go back to reference Kirn DR, Grill JD, Aisen P, et al. Centralizing prescreening data collection to inform data-driven approaches to clinical trial recruitment. Alzheimers Res Ther. 2023;15:88.PubMedPubMedCentralCrossRef Kirn DR, Grill JD, Aisen P, et al. Centralizing prescreening data collection to inform data-driven approaches to clinical trial recruitment. Alzheimers Res Ther. 2023;15:88.PubMedPubMedCentralCrossRef
31.
go back to reference Acuña-Villaorduña A, Baranda JC, Boehmer J, et al. Equitable access to clinical trials: how do we achieve it? Am Soc Clin Oncol Educ Book. 2023;43:e389838.PubMedCrossRef Acuña-Villaorduña A, Baranda JC, Boehmer J, et al. Equitable access to clinical trials: how do we achieve it? Am Soc Clin Oncol Educ Book. 2023;43:e389838.PubMedCrossRef
34.
35.
go back to reference Bestehorn K. Medizinische Register: ein Beitrag zur Versorgungsforschung. Med Klin. 2005;100:722–8.CrossRef Bestehorn K. Medizinische Register: ein Beitrag zur Versorgungsforschung. Med Klin. 2005;100:722–8.CrossRef
36.
go back to reference Williams WG. Uses and limitations of registry and academic databases. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2010;13:66–70.PubMedCrossRef Williams WG. Uses and limitations of registry and academic databases. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2010;13:66–70.PubMedCrossRef
37.
go back to reference Williams WG, McCrindle BW. Practical experience with databases for congenital heart disease: a registry versus an academic database. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2002;5:132–42.PubMedCrossRef Williams WG, McCrindle BW. Practical experience with databases for congenital heart disease: a registry versus an academic database. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2002;5:132–42.PubMedCrossRef
38.
go back to reference Tan MH, Thomas M, MacEachern MP. Using registries to recruit subjects for clinical trials. Contemp Clin Trials. 2015;41:31–8.PubMedCrossRef Tan MH, Thomas M, MacEachern MP. Using registries to recruit subjects for clinical trials. Contemp Clin Trials. 2015;41:31–8.PubMedCrossRef
40.
42.
43.
go back to reference ASCEND Study Collaborative Group, Aung T, Haynes R, et al. Cost-effective recruitment methods for a large randomised trial in people with diabetes: A Study of Cardiovascular Events iN Diabetes (ASCEND). Trials. 2016;17:286.PubMedCentralCrossRef ASCEND Study Collaborative Group, Aung T, Haynes R, et al. Cost-effective recruitment methods for a large randomised trial in people with diabetes: A Study of Cardiovascular Events iN Diabetes (ASCEND). Trials. 2016;17:286.PubMedCentralCrossRef
44.
go back to reference Achiron A, Givon U, Magalashvili D, et al. Effect of Alfacalcidol on multiple sclerosis-related fatigue: a randomized, double-blind placebo-controlled study. Mult Scler. 2015;21:767–75.PubMedCrossRef Achiron A, Givon U, Magalashvili D, et al. Effect of Alfacalcidol on multiple sclerosis-related fatigue: a randomized, double-blind placebo-controlled study. Mult Scler. 2015;21:767–75.PubMedCrossRef
45.
go back to reference Heywood J, Evangelou M, Goymer D, et al. Effective recruitment of participants to a phase I study using the internet and publicity releases through charities and patient organisations: analysis of the adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes (DILT1D). Trials. 2015;16:86.PubMedPubMedCentralCrossRef Heywood J, Evangelou M, Goymer D, et al. Effective recruitment of participants to a phase I study using the internet and publicity releases through charities and patient organisations: analysis of the adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes (DILT1D). Trials. 2015;16:86.PubMedPubMedCentralCrossRef
46.
go back to reference Oni C, Mitchell S, James K, Ng WF, Griffiths B, Hindmarsh V, Price E, Pease CT, Emery P, Lanyon P, Jones A, Bombardieri M, Sutcliffe N, Pitzalis C, Hunter J, Gupta M, McLaren J, Cooper A, Regan M, Giles I, …. UK Primary Sjögren’s Syndrome Registry. Eligibility for clinical trials in primary Sjögren's syndrome: lessons from the UK Primary Sjögren's Syndrome Registry. Rheumatology (Oxford, England). 2016;55(3):544–52. https://doi.org/10.1093/rheumatology/kev373. Oni C, Mitchell S, James K, Ng WF, Griffiths B, Hindmarsh V, Price E, Pease CT, Emery P, Lanyon P, Jones A, Bombardieri M, Sutcliffe N, Pitzalis C, Hunter J, Gupta M, McLaren J, Cooper A, Regan M, Giles I, …. UK Primary Sjögren’s Syndrome Registry. Eligibility for clinical trials in primary Sjögren's syndrome: lessons from the UK Primary Sjögren's Syndrome Registry. Rheumatology (Oxford, England). 2016;55(3):544–52. https://​doi.​org/​10.​1093/​rheumatology/​kev373.
47.
go back to reference Darmon A, Bhatt DL, Elbez Y, et al. External applicability of the COMPASS trial: an analysis of the reduction of atherothrombosis for continued health (REACH) registry. Eur Heart J. 2018;39:750–757a.PubMedCrossRef Darmon A, Bhatt DL, Elbez Y, et al. External applicability of the COMPASS trial: an analysis of the reduction of atherothrombosis for continued health (REACH) registry. Eur Heart J. 2018;39:750–757a.PubMedCrossRef
48.
go back to reference Huebner H, Kurbacher CM, Kuesters G, et al. Heregulin (HRG) assessment for clinical trial eligibility testing in a molecular registry (PRAEGNANT) in Germany. BMC Cancer. 2020;20:1091.PubMedPubMedCentralCrossRef Huebner H, Kurbacher CM, Kuesters G, et al. Heregulin (HRG) assessment for clinical trial eligibility testing in a molecular registry (PRAEGNANT) in Germany. BMC Cancer. 2020;20:1091.PubMedPubMedCentralCrossRef
49.
go back to reference van der Hout A, van Uden-Kraan CF, Holtmaat K, et al. Role of eHealth application Oncokompas in supporting self-management of symptoms and health-related quality of life in cancer survivors: a randomised, controlled trial. Lancet Oncol. 2020;21:80–94.PubMedCrossRef van der Hout A, van Uden-Kraan CF, Holtmaat K, et al. Role of eHealth application Oncokompas in supporting self-management of symptoms and health-related quality of life in cancer survivors: a randomised, controlled trial. Lancet Oncol. 2020;21:80–94.PubMedCrossRef
50.
go back to reference theFilnemus Myotonic Dystrophy Study Group, De Antonio M, Dogan C, et al. The DM-scope registry: a rare disease innovative framework bridging the gap between research and medical care. Orphanet J Rare Dis. 2019;14:122.CrossRef theFilnemus Myotonic Dystrophy Study Group, De Antonio M, Dogan C, et al. The DM-scope registry: a rare disease innovative framework bridging the gap between research and medical care. Orphanet J Rare Dis. 2019;14:122.CrossRef
51.
go back to reference Heidrich B, Cordes H-J, Klinker H, et al. Treatment extension of pegylated interferon alpha and ribavirin does not improve SVR in patients with genotypes 2/3 without rapid virological response (OPTEX Trial): a prospective, randomized, two-arm, multicentre phase IV clinical trial. PLoS One. 2015;10:e0128069.PubMedPubMedCentralCrossRef Heidrich B, Cordes H-J, Klinker H, et al. Treatment extension of pegylated interferon alpha and ribavirin does not improve SVR in patients with genotypes 2/3 without rapid virological response (OPTEX Trial): a prospective, randomized, two-arm, multicentre phase IV clinical trial. PLoS One. 2015;10:e0128069.PubMedPubMedCentralCrossRef
52.
go back to reference Toth GG, Lansky A, Baumbach A, et al. Validation of the all-comers design: results of the TARGET-AC substudy. Am Heart J. 2020;221:148–54.CrossRef Toth GG, Lansky A, Baumbach A, et al. Validation of the all-comers design: results of the TARGET-AC substudy. Am Heart J. 2020;221:148–54.CrossRef
53.
go back to reference Brown JC, Troxel AB, Ky B, et al. A randomized phase II dose–response exercise trial among colon cancer survivors: purpose, study design, methods, and recruitment results. Contemp Clin Trials. 2016;47:366–75.PubMedPubMedCentralCrossRef Brown JC, Troxel AB, Ky B, et al. A randomized phase II dose–response exercise trial among colon cancer survivors: purpose, study design, methods, and recruitment results. Contemp Clin Trials. 2016;47:366–75.PubMedPubMedCentralCrossRef
54.
go back to reference Ashing K, Rosales M. A telephonic-based trial to reduce depressive symptoms among Latina breast cancer survivors: trial to reduce depressive symptoms. Psychooncology. 2014;23:507–15.PubMedCrossRef Ashing K, Rosales M. A telephonic-based trial to reduce depressive symptoms among Latina breast cancer survivors: trial to reduce depressive symptoms. Psychooncology. 2014;23:507–15.PubMedCrossRef
55.
go back to reference Xiang JJ, Roy A, Summers C, et al. Brief report: implementation of a universal prescreening protocol to increase recruitment to lung cancer studies at a Veterans Affairs cancer center. JTO Clin Res Rep. 2022;3:100357.PubMedPubMedCentral Xiang JJ, Roy A, Summers C, et al. Brief report: implementation of a universal prescreening protocol to increase recruitment to lung cancer studies at a Veterans Affairs cancer center. JTO Clin Res Rep. 2022;3:100357.PubMedPubMedCentral
56.
go back to reference Russo R, Coultas D, Ashmore J, et al. Chronic obstructive pulmonary disease self-management activation research trial (COPD–SMART): results of recruitment and baseline patient characteristics. Contemp Clin Trials. 2015;41:192–201.PubMedPubMedCentralCrossRef Russo R, Coultas D, Ashmore J, et al. Chronic obstructive pulmonary disease self-management activation research trial (COPD–SMART): results of recruitment and baseline patient characteristics. Contemp Clin Trials. 2015;41:192–201.PubMedPubMedCentralCrossRef
57.
go back to reference Tamborlane WV, Chang P, Kollman C, et al. Eligibility for clinical trials is limited for youth with type 2 diabetes: insights from the Pediatric Diabetes Consortium T2D Clinic Registry. Pediatr Diabetes. 2018;19:1379–84.PubMedCrossRef Tamborlane WV, Chang P, Kollman C, et al. Eligibility for clinical trials is limited for youth with type 2 diabetes: insights from the Pediatric Diabetes Consortium T2D Clinic Registry. Pediatr Diabetes. 2018;19:1379–84.PubMedCrossRef
58.
go back to reference Danila MI, Chen L, Ruderman EM, et al. Evaluation of an intervention to support patient-rheumatologist conversations about escalating treatment in patients with rheumatoid arthritis: a proof-of-principle study. ACR Open Rheumatol. 2022;4:279–87.PubMedCrossRef Danila MI, Chen L, Ruderman EM, et al. Evaluation of an intervention to support patient-rheumatologist conversations about escalating treatment in patients with rheumatoid arthritis: a proof-of-principle study. ACR Open Rheumatol. 2022;4:279–87.PubMedCrossRef
59.
go back to reference Green MF, Bell JL, Hubbard CB, McCall SJ, McKinney MS, Riedel JE, Menendez CS, Abbruzzese JL, Strickler JH, Datto MB. Implementation of a Molecular Tumor Registry to Support the Adoption of Precision Oncology Within an Academic Medical Center: The Duke University Experience. JCO Precis Oncol. 2021;5:PO.21.00030. https://doi.org/10.1200/PO.21.00030. Green MF, Bell JL, Hubbard CB, McCall SJ, McKinney MS, Riedel JE, Menendez CS, Abbruzzese JL, Strickler JH, Datto MB. Implementation of a Molecular Tumor Registry to Support the Adoption of Precision Oncology Within an Academic Medical Center: The Duke University Experience. JCO Precis Oncol. 2021;5:PO.21.00030. https://​doi.​org/​10.​1200/​PO.​21.​00030.
60.
go back to reference Guerra CE, Kelly S, Redlinger C, et al. Pancreatic cancer clinical treatment trials accrual: a closer look at participation rates. Am J Clin Oncol. 2021;44:227–31.PubMedPubMedCentralCrossRef Guerra CE, Kelly S, Redlinger C, et al. Pancreatic cancer clinical treatment trials accrual: a closer look at participation rates. Am J Clin Oncol. 2021;44:227–31.PubMedPubMedCentralCrossRef
61.
go back to reference Wu J, Yakubov A, Abdul-Hay M, et al. Prescreening to increase therapeutic oncology trial enrollment at the largest public hospital in the United States. JCO Oncol Pract. 2022;18:e620–5.PubMedCrossRef Wu J, Yakubov A, Abdul-Hay M, et al. Prescreening to increase therapeutic oncology trial enrollment at the largest public hospital in the United States. JCO Oncol Pract. 2022;18:e620–5.PubMedCrossRef
62.
go back to reference Shadyab AH, LaCroix AZ, Feldman HH, et al. Recruitment of a multi-site randomized controlled trial of aerobic exercise for older adults with amnestic mild cognitive impairment: the EXERT trial. Alzheimers Dement. 2021;17:1808–17.PubMedCrossRef Shadyab AH, LaCroix AZ, Feldman HH, et al. Recruitment of a multi-site randomized controlled trial of aerobic exercise for older adults with amnestic mild cognitive impairment: the EXERT trial. Alzheimers Dement. 2021;17:1808–17.PubMedCrossRef
63.
go back to reference Mehta P, Raymond J, Han MK, et al. Recruitment of patients with amyotrophic lateral sclerosis for clinical trials and epidemiological studies: descriptive study of the National ALS Registry’s research notification mechanism. J Med Internet Res. 2021;23:e28021.PubMedPubMedCentralCrossRef Mehta P, Raymond J, Han MK, et al. Recruitment of patients with amyotrophic lateral sclerosis for clinical trials and epidemiological studies: descriptive study of the National ALS Registry’s research notification mechanism. J Med Internet Res. 2021;23:e28021.PubMedPubMedCentralCrossRef
64.
go back to reference Valle CG, Camp LN, Diamond M, et al. Recruitment of young adult cancer survivors into a randomized controlled trial of an mHealth physical activity intervention. Trials. 2022;23:254.PubMedPubMedCentralCrossRef Valle CG, Camp LN, Diamond M, et al. Recruitment of young adult cancer survivors into a randomized controlled trial of an mHealth physical activity intervention. Trials. 2022;23:254.PubMedPubMedCentralCrossRef
65.
go back to reference Curtis JR, Wright NC, Xie F, et al. Use of health plan combined with registry data to predict clinical trial recruitment. Clin Trials. 2014;11:96–101.PubMedCrossRef Curtis JR, Wright NC, Xie F, et al. Use of health plan combined with registry data to predict clinical trial recruitment. Clin Trials. 2014;11:96–101.PubMedCrossRef
66.
go back to reference Laugesen K, Ludvigsson JF, Schmidt M, et al. Nordic Health Registry-based research: a review of health care systems and key registries. Clin Epidemiol. 2021;13:533–54.PubMedPubMedCentralCrossRef Laugesen K, Ludvigsson JF, Schmidt M, et al. Nordic Health Registry-based research: a review of health care systems and key registries. Clin Epidemiol. 2021;13:533–54.PubMedPubMedCentralCrossRef
67.
go back to reference Børø S, Thoresen S, Boge Brant S, et al. Initial investigation of using Norwegian health data for the purpose of external comparator arms - an example for non-small cell lung cancer. Acta Oncol. 2023;62:1642–8.PubMedCrossRef Børø S, Thoresen S, Boge Brant S, et al. Initial investigation of using Norwegian health data for the purpose of external comparator arms - an example for non-small cell lung cancer. Acta Oncol. 2023;62:1642–8.PubMedCrossRef
68.
go back to reference Axelsson L, Alvariza A, Lindberg J, et al. Unmet palliative care needs among patients with end-stage kidney disease: a national registry study about the last week of life. J Pain Symptom Manage. 2018;55:236–44.PubMedCrossRef Axelsson L, Alvariza A, Lindberg J, et al. Unmet palliative care needs among patients with end-stage kidney disease: a national registry study about the last week of life. J Pain Symptom Manage. 2018;55:236–44.PubMedCrossRef
69.
go back to reference Nørgaard M, Mailhac A, Fagerlund K, et al. Treatment patterns, survival, and healthcare utilisation and costs in patients with locally advanced and metastatic bladder cancer in Denmark 2015–2020. Acta Oncol. 2023;62:1784–90.PubMedCrossRef Nørgaard M, Mailhac A, Fagerlund K, et al. Treatment patterns, survival, and healthcare utilisation and costs in patients with locally advanced and metastatic bladder cancer in Denmark 2015–2020. Acta Oncol. 2023;62:1784–90.PubMedCrossRef
70.
go back to reference Bakken IJ, Ariansen AMS, Knudsen GP, et al. The Norwegian Patient Registry and the Norwegian Registry for Primary Health Care: research potential of two nationwide health-care registries. Scand J Public Health. 2020;48:49–55.PubMedCrossRef Bakken IJ, Ariansen AMS, Knudsen GP, et al. The Norwegian Patient Registry and the Norwegian Registry for Primary Health Care: research potential of two nationwide health-care registries. Scand J Public Health. 2020;48:49–55.PubMedCrossRef
71.
go back to reference Pol T, Karlström P, Lund LH. Heart failure registries – future directions. J Cardiol. 2024;83:84–90.PubMedCrossRef Pol T, Karlström P, Lund LH. Heart failure registries – future directions. J Cardiol. 2024;83:84–90.PubMedCrossRef
72.
go back to reference Pålsson S, Pivodic A, Grönlund MA, et al. Cataract surgery in patients with uveitis: data from the Swedish National Cataract Register. Acta Ophthalmol. 2023;101:376–83.PubMedCrossRef Pålsson S, Pivodic A, Grönlund MA, et al. Cataract surgery in patients with uveitis: data from the Swedish National Cataract Register. Acta Ophthalmol. 2023;101:376–83.PubMedCrossRef
74.
go back to reference Rimel BJ, Lester J, Sabacan L, et al. A novel clinical trial recruitment strategy for women’s cancer. Gynecol Oncol. 2015;138:445–8.PubMedCrossRef Rimel BJ, Lester J, Sabacan L, et al. A novel clinical trial recruitment strategy for women’s cancer. Gynecol Oncol. 2015;138:445–8.PubMedCrossRef
75.
go back to reference Kluding PM, Denton J, Jamison TR, et al. Frontiers: integration of a research participant registry with medical clinic registration and electronic health records. Clin Transl Sci. 2015;8:405–11.PubMedPubMedCentralCrossRef Kluding PM, Denton J, Jamison TR, et al. Frontiers: integration of a research participant registry with medical clinic registration and electronic health records. Clin Transl Sci. 2015;8:405–11.PubMedPubMedCentralCrossRef
76.
go back to reference Mudaranthakam DP, Thompson J, Hu J, et al. A Curated Cancer Clinical Outcomes Database (C3OD) for accelerating patient recruitment in cancer clinical trials. JAMIA Open. 2018;1:166–71.PubMedPubMedCentralCrossRef Mudaranthakam DP, Thompson J, Hu J, et al. A Curated Cancer Clinical Outcomes Database (C3OD) for accelerating patient recruitment in cancer clinical trials. JAMIA Open. 2018;1:166–71.PubMedPubMedCentralCrossRef
77.
go back to reference Kannan V, Wilkinson KE, Varghese M, et al. Count me in: using a patient portal to minimize implicit bias in clinical research recruitment. J Am Med Inform Assoc. 2019;26:703–13.PubMedPubMedCentralCrossRef Kannan V, Wilkinson KE, Varghese M, et al. Count me in: using a patient portal to minimize implicit bias in clinical research recruitment. J Am Med Inform Assoc. 2019;26:703–13.PubMedPubMedCentralCrossRef
78.
go back to reference McKinstry B, Sullivan FM, Vasishta S, et al. Cohort profile: the Scottish research register SHARE. A register of people interested in research participation linked to NHS data sets. BMJ Open. 2017;7:e013351.PubMedPubMedCentralCrossRef McKinstry B, Sullivan FM, Vasishta S, et al. Cohort profile: the Scottish research register SHARE. A register of people interested in research participation linked to NHS data sets. BMJ Open. 2017;7:e013351.PubMedPubMedCentralCrossRef
79.
go back to reference Robotham D, Waterman S, Oduola S, et al. Facilitating mental health research for patients, clinicians and researchers: a mixed-method study. BMJ Open. 2016;6:e011127.PubMedPubMedCentralCrossRef Robotham D, Waterman S, Oduola S, et al. Facilitating mental health research for patients, clinicians and researchers: a mixed-method study. BMJ Open. 2016;6:e011127.PubMedPubMedCentralCrossRef
80.
go back to reference Vermunt L, Veal CD, Ter Meulen L, et al. European Prevention of Alzheimer’s Dementia Registry: recruitment and prescreening approach for a longitudinal cohort and prevention trials. Alzheimers Dement. 2018;14:837–42.PubMedCrossRef Vermunt L, Veal CD, Ter Meulen L, et al. European Prevention of Alzheimer’s Dementia Registry: recruitment and prescreening approach for a longitudinal cohort and prevention trials. Alzheimers Dement. 2018;14:837–42.PubMedCrossRef
81.
go back to reference Zwan MD, Van Der Flier WM, Cleutjens S, et al. Dutch Brain Research Registry for study participant recruitment: design and first results. A&D Transl Res & Clin Interv. 2021;7:e12132.CrossRef Zwan MD, Van Der Flier WM, Cleutjens S, et al. Dutch Brain Research Registry for study participant recruitment: design and first results. A&D Transl Res & Clin Interv. 2021;7:e12132.CrossRef
82.
go back to reference Langbaum JB, Karlawish J, Roberts JS, et al. GeneMatch: a novel recruitment registry using at-home APOE genotyping to enhance referrals to Alzheimer’s prevention studies. Alzheimers Dement. 2019;15:515–24.PubMedCrossRef Langbaum JB, Karlawish J, Roberts JS, et al. GeneMatch: a novel recruitment registry using at-home APOE genotyping to enhance referrals to Alzheimer’s prevention studies. Alzheimers Dement. 2019;15:515–24.PubMedCrossRef
83.
go back to reference Grill JD, Hoang D, Gillen DL, et al. Constructing a local potential participant registry to improve Alzheimer’s disease clinical research recruitment. JAD. 2018;63:1055–63.PubMedCrossRef Grill JD, Hoang D, Gillen DL, et al. Constructing a local potential participant registry to improve Alzheimer’s disease clinical research recruitment. JAD. 2018;63:1055–63.PubMedCrossRef
84.
go back to reference for the IMI-EPAD collaborators, Vermunt L, Muniz-Terrera G, et al. Prescreening for European Prevention of Alzheimer Dementia (EPAD) trial-ready cohort: impact of AD risk factors and recruitment settings. Alz Res Ther. 2020;12:8.CrossRef for the IMI-EPAD collaborators, Vermunt L, Muniz-Terrera G, et al. Prescreening for European Prevention of Alzheimer Dementia (EPAD) trial-ready cohort: impact of AD risk factors and recruitment settings. Alz Res Ther. 2020;12:8.CrossRef
85.
go back to reference Harwood RH, Goldberg SE, Brand A, et al. Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial. BMJ. 2023:e074787. Harwood RH, Goldberg SE, Brand A, et al. Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial. BMJ. 2023:e074787.
86.
go back to reference Jimenez-Maggiora GA, Bruschi S, Raman R, Langford O, Donohue M, Rafii MS, Sperling RA, Cummings JL, Aisen PS. TRC-PAD: Accelerating Recruitment of AD Clinical Trials through Innovative Information Technology. J Prev Alzheimers Dis. 2020;7(4):226–33. https://doi.org/10.14283/jpad.2020.48. Jimenez-Maggiora GA, Bruschi S, Raman R, Langford O, Donohue M, Rafii MS, Sperling RA, Cummings JL, Aisen PS. TRC-PAD: Accelerating Recruitment of AD Clinical Trials through Innovative Information Technology. J Prev Alzheimers Dis. 2020;7(4):226–33. https://​doi.​org/​10.​14283/​jpad.​2020.​48.
87.
go back to reference Langbaum JB, High N, Nichols J, Kettenhoven C, Reiman EM, Tariot PN. The Alzheimer's Prevention Registry: A Large Internet-Based Participant Recruitment Registry to Accelerate Referrals to Alzheimer's-Focused Studies. J Prev Alzheimers Dis. 2020;7(4):242–50. https://doi.org/10.14283/jpad.2020.31. Langbaum JB, High N, Nichols J, Kettenhoven C, Reiman EM, Tariot PN. The Alzheimer's Prevention Registry: A Large Internet-Based Participant Recruitment Registry to Accelerate Referrals to Alzheimer's-Focused Studies. J Prev Alzheimers Dis. 2020;7(4):242–50. https://​doi.​org/​10.​14283/​jpad.​2020.​31.
88.
go back to reference Milne R, Bunnik E, Tromp K, Bemelmans S, Badger S, Gove D, Maman M, Schermer M, Truyen L, Brayne C, Richard E. Ethical Issues in the Development of Readiness Cohorts in Alzheimer's Disease Research. J Prev Alzheimers Dis. 2017;4(2):125–31. https://doi.org/10.14283/jpad.2017.5. Milne R, Bunnik E, Tromp K, Bemelmans S, Badger S, Gove D, Maman M, Schermer M, Truyen L, Brayne C, Richard E. Ethical Issues in the Development of Readiness Cohorts in Alzheimer's Disease Research. J Prev Alzheimers Dis. 2017;4(2):125–31. https://​doi.​org/​10.​14283/​jpad.​2017.​5.
89.
go back to reference Morgan RL, Whaley P, Thayer KA, et al. Identifying the PECO: a framework for formulating good questions to explore the association of environmental and other exposures with health outcomes. Environ Int. 2018;121:1027–31.PubMedPubMedCentralCrossRef Morgan RL, Whaley P, Thayer KA, et al. Identifying the PECO: a framework for formulating good questions to explore the association of environmental and other exposures with health outcomes. Environ Int. 2018;121:1027–31.PubMedPubMedCentralCrossRef
90.
go back to reference Kitchenham B. Guidelines for performing Systematic Literature Reviews in Software Engineering, Version 2.3, EBSE Technical Report EBSE-2007-01, Keele University and University of Durham. 2007. Kitchenham B. Guidelines for performing Systematic Literature Reviews in Software Engineering, Version 2.3, EBSE Technical Report EBSE-2007-01, Keele University and University of Durham. 2007.
91.
go back to reference Longinetti E, Regodón Wallin A, Samuelsson K, et al. The Swedish motor neuron disease quality registry. Amyotroph Lateral Scler Frontotemporal Degener. 2018;19:528–37.PubMedCrossRef Longinetti E, Regodón Wallin A, Samuelsson K, et al. The Swedish motor neuron disease quality registry. Amyotroph Lateral Scler Frontotemporal Degener. 2018;19:528–37.PubMedCrossRef
93.
go back to reference Diguiseppi C, Goss C, Xu S, et al. Telephone screening for hazardous drinking among injured patients seen in acute care clinics: feasibility study. Alcohol Alcohol. 2006;41:438–45.PubMedCrossRef Diguiseppi C, Goss C, Xu S, et al. Telephone screening for hazardous drinking among injured patients seen in acute care clinics: feasibility study. Alcohol Alcohol. 2006;41:438–45.PubMedCrossRef
94.
go back to reference Graham A, Goss C, Xu S, et al. Effect of using different modes to administer the AUDIT-C on identification of hazardous drinking and acquiescence to trial participation among injured patients. Alcohol Alcohol. 2007;42:423–9.PubMedCrossRef Graham A, Goss C, Xu S, et al. Effect of using different modes to administer the AUDIT-C on identification of hazardous drinking and acquiescence to trial participation among injured patients. Alcohol Alcohol. 2007;42:423–9.PubMedCrossRef
95.
go back to reference Davis MK, Fine NM. An urgent need for data to drive decision making: rationale for the Canadian Registry for Amyloidosis Research. Can J Cardiol. 2020;36:447–9.PubMedCrossRef Davis MK, Fine NM. An urgent need for data to drive decision making: rationale for the Canadian Registry for Amyloidosis Research. Can J Cardiol. 2020;36:447–9.PubMedCrossRef
96.
go back to reference Ieva F, Gale CP, Sharples LD. Contemporary roles of registries in clinical cardiology: when do we need randomized trials? Expert Rev Cardiovasc Ther. 2014;12:1383–6.PubMedCrossRef Ieva F, Gale CP, Sharples LD. Contemporary roles of registries in clinical cardiology: when do we need randomized trials? Expert Rev Cardiovasc Ther. 2014;12:1383–6.PubMedCrossRef
97.
go back to reference Levesque E, Leclerc D, Puymirat J, et al. Developing registries of volunteers: key principles to manage issues regarding personal information protection. J Med Ethics. 2010;36:712–4.PubMedCrossRef Levesque E, Leclerc D, Puymirat J, et al. Developing registries of volunteers: key principles to manage issues regarding personal information protection. J Med Ethics. 2010;36:712–4.PubMedCrossRef
98.
go back to reference Lasagna L. Problems in publication of clinical trial methodology. Clin Pharmacol Ther. 1979;25:751–3.PubMedCrossRef Lasagna L. Problems in publication of clinical trial methodology. Clin Pharmacol Ther. 1979;25:751–3.PubMedCrossRef
99.
go back to reference O’Sullivan Greene E, Shiely F. Recording and reporting of recruitment strategies in trial protocols, registries, and publications was nonexistent. J Clin Epidemiol. 2022;152:248–56.PubMedCrossRef O’Sullivan Greene E, Shiely F. Recording and reporting of recruitment strategies in trial protocols, registries, and publications was nonexistent. J Clin Epidemiol. 2022;152:248–56.PubMedCrossRef
100.
go back to reference Ni Y, Wright J, Perentesis J, et al. Increasing the efficiency of trial-patient matching: automated clinical trial eligibility pre-screening for pediatric oncology patients. BMC Med Inform Decis Mak. 2015;15:28.PubMedPubMedCentralCrossRef Ni Y, Wright J, Perentesis J, et al. Increasing the efficiency of trial-patient matching: automated clinical trial eligibility pre-screening for pediatric oncology patients. BMC Med Inform Decis Mak. 2015;15:28.PubMedPubMedCentralCrossRef
101.
go back to reference Ni Y, Kennebeck S, Dexheimer JW, et al. Automated clinical trial eligibility prescreening: increasing the efficiency of patient identification for clinical trials in the emergency department. J Am Med Inform Assoc. 2015;22:166–78.PubMedCrossRef Ni Y, Kennebeck S, Dexheimer JW, et al. Automated clinical trial eligibility prescreening: increasing the efficiency of patient identification for clinical trials in the emergency department. J Am Med Inform Assoc. 2015;22:166–78.PubMedCrossRef
Metadata
Title
The usage of population and disease registries as pre-screening tools for clinical trials, a systematic review
Authors
Juliette Foucher
Louisa Azizi
Linn Öijerstedt
Ulf Kläppe
Caroline Ingre
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Systematic Reviews / Issue 1/2024
Electronic ISSN: 2046-4053
DOI
https://doi.org/10.1186/s13643-024-02533-0

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