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Meeting the Challenges of Patient Recruitment

A Role for Electronic Health Records

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Abstract

The recruitment rate of adult patients into clinical trials continues to be low. There are a number of barriers to recruitment and, for the most part, these can be classified as patient-, physician-, organisation- or protocolrelated. For practical reasons the process of trial recruitment can be divided into three steps: awareness of the trial, assessment of patient eligibility and the decision to participate. Two key strategies to improve patient recruitment are related to (i) knowledge, information and data management, and (ii) changing the behaviour of physicians and patients. Patient recruitment strategies cover individual services (e.g. call centre, web-based outreach campaigns) or integrated services (e.g. provided by recruitment companies). Unfortunately, there is only limited and inconclusive evidence from randomised or quasi-randomised trials comparing different recruitment strategies.

The integration of electronic health records (EHRs) into clinical trials has major potential to increase recruitment rates, as demonstrated by a small number of recent studies. However, there are prerequisites for the successful application of EHR systems in clinical trials, including the provision of adequate patient data, availability of technical solutions from vendors and dual operability between the worlds of medical care and clinical research; changes in the attitudes of physicians and patients are also required. Nevertheless it should be borne in mind that patient recruitment is a complex process and successful strategies are likely to require several complementary approaches in order to achieve the goal of improved enrolment rates.

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References

  1. Corrie P, Shaw J, Harris R. Rate limiting factors in recruitment of patients to clinical trials in cancer research: descriptive study. BMJ 2003; 327 (7410): 320–1

    Article  PubMed  Google Scholar 

  2. Wright JR, Crooks D, Ellis PM, et al. Factors that influence the recruitment of patients to phase III studies in oncology: the perspective of the clinical research associate. Cancer 2002; 95 (7): 1584–91

    Article  PubMed  Google Scholar 

  3. Mills EJ, Seely D, Rachlis B, et al. Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. Lancet Oncol 2006; 7 (2): 141–8

    Article  PubMed  Google Scholar 

  4. Go RS, Frisby KA, Lee JA, et al. Clinical trial accrual among new cancer patients at a community-based cancer center. Cancer 2006; 106 (2): 426–33

    Article  PubMed  Google Scholar 

  5. Lara PN Jr, Higdon R, Lim N, et al. Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment. J Clin Oncol 2001; 19 (6): 1728–33

    PubMed  Google Scholar 

  6. Wright JR, Whelan TJ, Schiff S, et al. Why cancer patients enter randomized clinical trials: exploring the factors that influence their decision. J Clin Oncol 2004; 22 (21): 4312–8

    Article  PubMed  Google Scholar 

  7. Townsley CA, Selby R, Siu LL. Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials. J Clin Oncol 2005; 23 (13): 3112–24

    Article  PubMed  Google Scholar 

  8. Sullivan J. Subject recruitment and retention: barriers to success. Appl Clin Trials 2004 Apr 1 [online]. Available from URL: http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?.id=89608 [Accessed 2007 Mar 6]

    Google Scholar 

  9. Melisko ME, Hassin F, Metzroth L, et al. Patient and physician attitudes toward breast cancer clinical trials: developing interventions based on understanding barriers. Clin Breast Cancer 2005; 6 (1): 45–54

    Article  PubMed  Google Scholar 

  10. Verheggen FW, Nieman F, Jonkers R. Determinants of patient participation in clinical studies requiring informed consent: why patients enter a clinical trial. Patient Educ Couns 1998; 35 (2): 111–25

    Article  PubMed  CAS  Google Scholar 

  11. Avis NE, Smith KW, Link CL, et al. Factors associated with participation in breast cancer treatment clinical trials. J Clin Oncol 2006; 24 (12): 1860–7

    Article  PubMed  Google Scholar 

  12. Sears SR, Stanton AL, Kwan L, et al. Recruitment and retention challenges in breast cancer survivorship research: results from a multisite, randomized intervention trial in women with early stage breast cancer. Cancer Epidemiol Biomarkers Prev 2003; 12 (10): 1087–90

    PubMed  Google Scholar 

  13. Mosis G, Dieleman JP, Stricker BC, et al. A randomized database study in general practice yielded quality data but patient recruitment in routine consultation was not practical. J Clin Epidemiol 2006; 59 (5): 497–502

    Article  PubMed  Google Scholar 

  14. Carlson RW, Tu SW, Lane NM, et al. Computer-based screening of patients with HIV/AIDS for clinical-trial eligibility. Online J Curr Clin Trials 1995; 179: 3347

    Google Scholar 

  15. Seroussi B, Bouaud J. Using OncoDoc as a computer-based eligibility screening system to improve accrual onto breast cancer clinical trials. Artif Intell Med 2003; 29 (1–2): 153–67

    Article  PubMed  Google Scholar 

  16. Breitfeld PP, Weisburd M, Overhage JM, et al. Pilot study of a point-of-use decision support tool for cancer clinical trials eligibility. J Am Med Inform Assoc 1999; 6 (6): 466–77

    Article  PubMed  CAS  Google Scholar 

  17. Fink E, Kokku PK, Nikiforou S, et al. Selection of patients for clinical trials: an interactive web-based system. Artif Intell Med 2004; 31 (3): 241–54

    Article  PubMed  Google Scholar 

  18. Hubbard JW, Anderson DL, Nickens L, et al. Trials and tribulations: under pressure? [online]. Available from URL: http://www.ngpharma.eu.com/pastissue/article.asp?art=25517&issue=143 [Accessed 2007 Mar 6]

    Google Scholar 

  19. Anderson DL. The patient recruitment market: an overview of today’s issues. Appl Clin Trials 2003 Nov 2 [online]. Available from URL: http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?.id=77707 [Accessed 2007 Mar 6]

    Google Scholar 

  20. Nichols L, Martindale-Adams J, Burns R, et al. Social marketing as a framework for recruitment: illustrations from the REACH study. J Aging Health 2004; 16 (5 Suppl.): 157–76S

    Article  Google Scholar 

  21. Seguine ED. EHR and subject recruitment: what’s different now. Bioexecutive Int 2007 Jan [online]. Available from URL: http://www.fast-track.com/pdfs/Bioexecutive-Jan07.pdf [Accessed 2007 Mar 6]

    Google Scholar 

  22. Kilpatrick FS, Floyd J, Goulson H. Guest opinion: patient enrollment best practice model significantly improves timeline outcomes. Health Communications Group. 2006 Feb 1 [online]. Available from URL: http://www.eyeforpharma.com/search.asp?.news=49325 [Accessed 2007 Mar 6]

    Google Scholar 

  23. Fraser HE, Drayton S, Wang AE. Delay no more: improve patient recruitment and reduce time to market in the pharmaceutical industry [online]. Available from URL: http://www-935.ibm.com/services/us/index.wss/ibvstudy/imc/a1000616?.cntxt=a1000060 [Accessed 2007 Mar 6]

    Google Scholar 

  24. Jones J. Access all areas: global patient recruitment. Good Clin Pract J 2006 Jun; 13 (6): 35–38 [online]. Available from URL: http://www.kendle.com/media/recent_editorials/gcpj0606.pdf [Accessed 2007 Mar 6]

    Google Scholar 

  25. Bachenheimer JF, Brescia BA. Reinventing patient recruitment: revolutionary ideas for clinical trials success. Burlington (VT): Gower Publishing Co., 2007

    Google Scholar 

  26. Bachenheimer JF. Good recruitment practice: working to create the bond between study and subject. Appl Clin Trials 2004 Apr 1 [online]. Available from URL: http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?.id=89626 [Accessed 2007 Mar 6]

    Google Scholar 

  27. Lai GY, Gary TL, Tilburt J, et al. Effectiveness of strategies to recruit under-represented populations into cancer clinical trials. Clin Trials 2006; 3 (2):133–41

    Article  PubMed  Google Scholar 

  28. Brewster WR, Anton-Culver H, Ziogas A, et al. Recruitment strategies for cervical cancer prevention study. Gynecol Oncol 2002 May; 85 (2): 250–4

    Article  PubMed  CAS  Google Scholar 

  29. Ford ME, Havstad SL, Davis SD. A randomized trial of recruitment methods for older African American men in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. Clin Trials 2004; 1 (4): 343–51

    Article  PubMed  Google Scholar 

  30. Linnan LA, Emmons KM, Klar N, et al. Challenges to improving the impact of worksite cancer prevention programs: comparing reach, enrollment, and attrition using active versus passive recruitment strategies. Ann Behav Med 2002 Spring; 24 (2): 157–66

    Article  PubMed  Google Scholar 

  31. Moinpour CM, Atkinson JO, Thomas SM, et al. Minority recruitment in the prostate cancer prevention trial. Ann Epidemiol 2000 Nov; 10 (8 Suppl.): S85–91

    Article  PubMed  CAS  Google Scholar 

  32. Paskett ED, Cooper MR, Stark N, et al. Clinical trial enrollment of rural patients with cancer. Cancer Pract 2002; 10 (1): 28–35

    Article  PubMed  Google Scholar 

  33. Kimmick GG, Peterson BL, Kornblith AB, et al. Improving accrual of older persons to cancer treatment trials: a randomized trial comparing an educational intervention with standard information: CALGB 360001. J Clin Oncol 2005; 23 (10): 2201–7

    Article  PubMed  Google Scholar 

  34. Junghans C, Feder G, Hemingway H, et al. Recruiting patients to medical research: double blind randomised trial of “opt-in” versus “opt-out” strategies. BMJ 2005; 331 (7522): 940

    Article  PubMed  Google Scholar 

  35. Trelle S, Staak JO, Jensen M, et al. Implementation and evaluation of a central coordination office for clinical trials in a tertiary care hospital. Onkologie 2005; 28 (8–9): 407–11

    Article  PubMed  Google Scholar 

  36. Mayor S. Lung cancer trial has problems in recruitment. BMJ 2000; 321 (7255): 195A

    Google Scholar 

  37. Thiele KP, Rheinberger P. “Unmöglich” gibt es nicht. Deutsches Arzteblatt 2003; 100 (18): A1044–6

    Google Scholar 

  38. Cancer Research UK. New training course could boost clinical trial recruitment. 2004 Nov 16 [press release; online]. Available from URL: http://info.cancerresearchuk.org/news/pressreleases/2004/november/57196 [Accessed 2007 Mar 6]

    Google Scholar 

  39. Kilpatrick F. Rev up patient recruitment: consultant agencies can help pharma companies find patients — and bring products to market — faster. Pharm Executive 2002 Apr 1 [online]. Available from URL: http://www.pharmexeccom/pharmexec/article/articleDetail.jsp?.id=14491 [Accessed 2007 Mar 6]

    Google Scholar 

  40. California Breast Cancer Research Program/University of California, San Francisco. BCT.org: feasibility of a clinical trial matching tool [online]. Available from URL: http://cbcrp.org/research/PageGrant.asp?.grant_id=2636 [Accessed 2007 Mar 6]

    Google Scholar 

  41. BBK Worldwide (BBK Healthcare Inc.) ®[online]. Available from URL: http://www.bbk2310.com [Accessed 2007 May 7]

  42. DecisionView Inc. DecisionViewTM [online]. Available from URL: http://www.decisionview.com [Accessed 2007 May 7]

  43. The MITRE Corporation. Electronic health records overview. 2006 Apr [online]. Available from URL: http://www.ncrr.nih.gov/CRInformatics/EHR.pdf [Accessed 2007 Mar 6]

    Google Scholar 

  44. Faster cures: the Center for Accelerating Medical Solutions. White Paper Fall 2005. Think research, using electronic medical, records to bridge patient care and research [online]. Available from URL: http://www.hca.wa.gov/hit/doc/faster_cures_emr_whitepaper.pdf [Accessed 2007 Mar 16]

    Google Scholar 

  45. Mowry M, Constantinou D. Electronic health records: a magic pill? Appl Clin Trials 2007 Feb 1 [online]. Available from URL: http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=401622 [Accessed 2007 Mar 6]

    Google Scholar 

  46. Souza T, Kush R, Evans JP. Global clinical data interchange standards are here! Drug Discov Today 2007; 12 (3–4): 174–81

    Article  PubMed  Google Scholar 

  47. Innovative Medicines Initiative. The innovative medicines initiative (IMI) strategic research agenda [online]. Available from URL: http://www.imi-europe.org/Publications.aspx?.viewCategory=Researchx20Agenda [Accessed 2007 Mar 6]

    Google Scholar 

  48. Turisco F, Keogh D, Stubbs C, et al. Current status of integrating information technologies into the clinical research enterprise within US academic health centers: strategic value and opportunities for investment. J Investig Med 2005; 53 (8): 425–33

    Article  PubMed  Google Scholar 

  49. Kamal J, Pasuparthi K, Rogers P, et al. Using an information warehouse to screen patients for clinical trials: a prototype. AMIA Annu Symp Proc 2005; 2005: 1004

    Google Scholar 

  50. The Samuel Bronfman Department of Medicine. Automation of patient recruitment for clinical trials: clinical trial recruitment tool [online]. Available from URL:http://www.mssm.edu/medicine/medical-informatics/projects.shtml [Accessed 2007 Mar 6]

    Google Scholar 

  51. Lieberman MI, Embi P, Ricciardi TN, et al. Accelerating biopharmaceutical development in the decade of health information technology. Biotechnol Healthc 2005 Aug [online]. Available from URL: http://www.biotechnologyhealthcare.com/journal/fulltext/2/4/BH0204052.pdf [Accessed 2007 Mar 16]

    Google Scholar 

  52. Canavan C, Grossman S, Kush R, et al. Integrating recruitment into ehealth patient records: electronic health records are a viable alternative to today’s subject recruitment methods. Appl Clin Trials 2006 Jun 1 [online]. Available from URL: http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?.id=334569 [Accessed 2007 Mar 6]

    Google Scholar 

  53. Pace WD, Staton EW, Holcomb S. Practice-based research network studies in the age of HIPAA. Ann Fam Med 2005; 3 Suppl. 1: S38–45

    Article  PubMed  Google Scholar 

  54. Embi PJ, Jain A, Clark J, et al. Development of an electronic health record-based Clinical Trial Alert system to enhance recruitment at the point of care. AMIA Annu Symp Proc 2005 2005, 5

    Google Scholar 

  55. Embi PJ, Jain A, Clark J, et al. Effect of a clinical trial alert system on physician participation in trial recruitment. Arch Intern Med 2005; 165 (19): 2272–7

    Article  PubMed  Google Scholar 

  56. Afrin LB, Oates JC, Boyd CK, et al. Leveraging of open EMR architecture for clinical trial accrual. AMIA Annu Sypm Proc 2003; 2003: 16–20

    Google Scholar 

  57. Weiner DL, Butte AJ, Hibberd PL, et al. Computerized recruiting for clinical trials in real time. Ann Emerg Med 2003; 41 (2): 242–6

    Article  PubMed  Google Scholar 

  58. Miller JL. The EHR solution to clinical trial recruitment in physician groups. Health Manag Technol 2006; 27 (12): 22–5

    PubMed  Google Scholar 

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Acknowledgements

No sources of funding were used to assist in the preparation of this manuscript. There are no conflicts of interest for the authors. Dr Q. Yang, Heinrich-Heine-University, Duesseldorf, Germany, provided writing assistance for this manuscript.

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Ohmann, C., Kuchinke, W. Meeting the Challenges of Patient Recruitment. Int J Pharm Med 21, 263–270 (2007). https://doi.org/10.2165/00124363-200721040-00002

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