Barriers to Cancer Clinical Trial Participation Among Saudi Nationals: A Cross-Sectional Study
Abstract
This study aims to determine the factors that act as barriers to Saudi cancer patients in participating in a clinical trial (CT). A total of 244 patients from two different tertiary level hospitals (King Khalid University Hospital and King Fahad Medical City Hospital) in Riyadh, Saudi Arabia, participated in this cross-sectional study. The participants were interviewed by a trained researcher between September and November 2015. All respondents answered a three-part questionnaire which includes demographics, clinical information, and questions related to awareness of CTs, willingness to participate, and factors affecting participation in CTs. The mean age of the participants was 50.83, and 57 % of the participants were females. Most of the participants (63.5 %) were currently being treated for cancer, and 28 % were diagnosed with breast cancer followed by colorectal cancer. Health status or quality of life was self-reported as acceptable by 27.9 % of the participants, and 25 % of the participants at stage II of cancer. The factors that act as barriers to Saudi cancer patients in participating in a CT can be categorized into patient- and physician-related factors. Patient factors include lack of awareness, misconception and fear in participating in CTs; physician-related factors comprise of lack of encouragement from physician to patients in participating in a CT. The study identified few major barriers to participation in CTs. Increased patient awareness and recruitment strategies are required to increase accrual of patients including training for physicians and disseminating easy-to-read tools to the public.
Keywords
Barriers Cancer clinical trials Patient accrual Saudi ArabiaNotes
Acknowledgments
The authors would like to extend their sincere appreciation to the Deanship of Scientific Research at King Saud University for funding this Research Group (RG# 1435-024).
Compliance with Ethical Standards
Conflict of interest
The authors certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript.
Informed consent
Informed consent was obtained from all individual participants included in the study.
Ethical approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
References
- AL-Tannir, M. A., El-Bakri, N., & Abu-Shaheen, A. K. (2016). Knowledge, attitudes and perceptions of saudis towards participating in clinical trials. PLoS One, 11(2), e0143893. doi:10.1371/journal.pone.0143893.CrossRefPubMedPubMedCentralGoogle Scholar
- Avis, N. E., Smith, K. W., Link, C. L., Hortobagyi, G. N., & Rivera, E. (2006). Factors associated with participation in breast cancer treatment clinical trials. Journal of Clinical Oncology, 24(12), 1860–1867.CrossRefPubMedGoogle Scholar
- Baquet, C. R., Commiskey, P., Mullins, C. D., & Mishra, S. I. (2006). Recruitment and participation in clinical trials: Socio-demographic, rural/urban, and health care access predictors. Cancer Detection and Prevention, 30(1), 24–33. doi:10.1016/j.cdp.2005.12.001.CrossRefPubMedPubMedCentralGoogle Scholar
- Bawazir, S. A., Hashan, H., Al Hatareshah, A., Al Ghamdi, A., & Al, Shahwan K. (2014). Regulating clinical trials in Saudi Arabia. Applied Clinical Research, Clinical Trials and Regulatory Affairs, 1, 2–9.CrossRefGoogle Scholar
- Bazarbashi, S., Hassan, A., Eldin, A. M., Soudy, H., & Hussain, F. (2015). Awareness and perceptions of clinical trials in cancer patients and their families in Saudi Arabia. Journal of Cancer Education, 30(4), 655–659. doi:10.1007/s13187-015-0797-0.CrossRefPubMedGoogle Scholar
- Berrino, F., De Angelis, R., Sant, M., Rosso, S., Bielska-Lasota, M., Coebergh, J. W., et al. (2007). Survival for eight major cancers and all cancers combined for European adults diagnosed in 1995–99: Results of the EUROCARE-4 study. The lancet Oncology, 8, 773–783.CrossRefPubMedGoogle Scholar
- Bleyer, A., Montello, M., Budd, T., & Saxman, S. (2005). National survival trends of young adults with sarcoma: Lack of progress is associated with lack of clinical trial participation. Cancer, 103, 1891–1897. doi:10.1002/cncr.20995.CrossRefPubMedGoogle Scholar
- Brandberg, Y., Johansson, H., & Bergenmar, M. (2016). Patients’ knowledge and perceived understanding—Associations with consenting to participate in cancer clinical trials. Contemporary Clinical Trials Communications, 2, 6–11.CrossRefGoogle Scholar
- Burt, T., Dhillon, S., Sharma, P., Khan, D., Deepa, M. V., Alam, S., et al. (2013). PARTAKE survey of public knowledge and perceptions of clinical research in India. PLoS ONE, 8(7), e68666. doi:10.1371/journal.pone.0068666.CrossRefPubMedPubMedCentralGoogle Scholar
- Chow, C. J., Habermann, E. B., Abraham, A., Zhu, Y., Vickers, S. M., Rothenberger, D. A., et al. (2013). Does enrollment in cancer trials improve survival? Journal of the American College of Surgeons, 216, 774–780. doi:10.1016/j.jamcollsurg.2012.12.036.CrossRefPubMedPubMedCentralGoogle Scholar
- Clinical trials. (2015). A service of the U.S. National Institutes of Health. http://clinicalTrials.gov/ Accessed 2 Sept 2015.
- Delgado-Sanz, M. C., García-Mendizábal, M. J., Pollán, M., Forjaz, M. J., López-Abente, G., Aragonés, N., et al. (2011). Heath-related quality of life in Spanish breast cancer patients: A systematic review. Health and Quality of Life Outcomes, 9, 3. doi:10.1186/1477-7525-9-3.CrossRefPubMedPubMedCentralGoogle Scholar
- Denson, A. C., & Mahipal, A. (2014). Participation of the elderly population in clinical trials: Barriers and solutions. Cancer Control, 21(3), 209–214.PubMedGoogle Scholar
- Dilts, D. M., Sandler, A. B., Cheng, S. K., Crites, J. S., Ferranti, L. B., Wu, A. Y., et al. (2009). Steps and time to process clinical trials at the cancer therapy evaluation program. Journal of Clinical Oncology, 27, 1761–1766.CrossRefPubMedPubMedCentralGoogle Scholar
- DuBois, A., Rochon, J., Lamparter, C., Pfisterer, J., Organkommission, A. G. O., & Pfisterer, O. V. A. R. (2005). Pattern of care and impact of participation in clinical studies on the outcome in ovarian cancer. International Journal of Gynecological Cancer, 15, 183–191.CrossRefGoogle Scholar
- Eurocare Protocol (2013) EUROCARE-5. http://www.eurocare.it/Eurocare5/DocumentsEU5/tabid/91/Default.aspx. Accessed 23 Mar 2013.
- Go, R. S., Frisby, K. A., Lee, J. A., Mathiason, M. A., Meyer, C. M., Ostern, J. L., et al. (2006). Clinical trial accrual among new cancer patients at a community-based cancer center. Cancer, 106, 426–433.CrossRefPubMedGoogle Scholar
- Hall, M. J., Egleston, B., Miller, S. M., Buzaglo, J. S., Millard, J., Ridgway, C., et al. (2010). Barriers to participation in cancer prevention clinical trials. Acta Oncologica, 49(6), 757–766. doi:10.3109/0284186X.2010.485209.CrossRefPubMedPubMedCentralGoogle Scholar
- Holman, A. J., Neradilek, M. B., Dryland, D. D., Neiman, R. A., Brown, P. B., & Ettlinger, R. E. (2010). Patient-derived determinants for participation in placebo-controlled clinical trials for fibromyalgia. Current Pain and Headache Reports, 14(6), 470–476. doi:10.1007/s11916-010-0152-4.CrossRefPubMedGoogle Scholar
- Hussain-Gambles, M., Atkin, K., & Leese, B. (2006). South Asian participation in clinical trials: The views of lay people and health professionals. Health Policy, 77(2), 149–165.CrossRefPubMedGoogle Scholar
- Javid, S. H., Unger, J. M., Gralow, J. R., Moinpour, C. M., Wozniak, A. J., Goodwin, J. W., et al. (2012). A prospective analysis of the influence of older age on physician and patient decision-making when considering enrollment in breast cancer clinical trials (SWOG S0316). The Oncologist, 17(9), 1180–1190. doi:10.1634/theoncologist.2011-0384.CrossRefPubMedPubMedCentralGoogle Scholar
- Karlberg, J. (2009). Biomedical publication trend by geographical area. Clinical Trial Magnifier, 2, 672.Google Scholar
- Kinder, B. W., Sherman, A. C., Young, L. R., Hagaman, J. T., Oprescu, N., Byrnes, S., et al. (2010). Predictors for clinical trial participation in the rare lung disease lymphangioleiomyomatosis. Respiratory Medicine, 104(4), 578–583. doi:10.1016/j.rmed.2009.09.023.CrossRefPubMedGoogle Scholar
- Lam, K. K., Li, W. H., Chiu, S. Y., & Chan, G. C. (2016). The impact of cancer and its treatment on physical activity levels and quality of life among young Hong Kong Chinese cancer patients. European Journal of Oncology Nursing, 21, 83–89. doi:10.1016/j.ejon.2016.01.007.CrossRefPubMedGoogle Scholar
- Lara, P. N., Jr., Paterniti, D. A., Chiechi, C., Turrell, C., Morain, C., Horan, N., et al. (2005). Evaluation of factors affecting awareness of and willingness to participate in cancer clinical trials. Journal of Clinical Oncology, 23, 9282–9289.CrossRefPubMedGoogle Scholar
- Manne, S., Kashy, D., Albrecht, T., Wong, Y. N., Lederman Flamm, A., Benson, A. B., 3rd, et al. (2015). Attitudinal barriers to participation in oncology clinical trials: Factor analysis and correlates of barriers. European Journal of Cancer Care, 24(1), 28–38. doi:10.1111/ecc.12180.CrossRefPubMedGoogle Scholar
- Mannel, R. S., Walker, J. L., Gould, N., Scribner, D. R., Jr., Kamelle, S., Tillmanns, T., et al. (2003). Impact of individual physicians on enrollment of patients into clinical trials. American Journal of Clinical Oncology, 26(2), 171–173.CrossRefPubMedGoogle Scholar
- Mao, J. J., Tan, T., Li, S. Q., Meghani, S. H., Glanz, K., & Bruner, D. (2014). Attitudes and barriers towards participation in an acupuncture trial among breast cancer patients: A survey study. BMC Complementary and Alternative Medicine, 14, 7. doi:10.1186/1472-6882-14-7.CrossRefPubMedPubMedCentralGoogle Scholar
- Mills, E. J., Seely, D., Rachlis, B., Griffith, L., Wu, P., Wilson, K., et al. (2006). Barriers to participation in clinical trials of cancer: A meta-analysis and systematic review of patient-reported factors. The lancet Oncology, 7(2), 141–148.CrossRefPubMedGoogle Scholar
- Ministry of Health (2015) Council of Health Services, Saudi Cancer Registry. Cancer Incidence Report 2010. http://www.chs.gov.sa/Ar/mediacenter/NewsLetter/2010%20Report%20(1).pdf. Accessed 2 Sept 2015.
- Sabesan, S., Burgher, B., Buettner, P., Piliouras, P., Otty, Z., Varma, S., et al. (2011). Attitudes, knowledge and barriers to participation in cancer clinical trials among rural and remote patients. Asia Pacific Journal of Clinical Oncology, 7(1), 27–33.CrossRefPubMedGoogle Scholar
- Simon, M. S., Du, W., Flaherty, L., Philip, P. A., Lorusso, P., Miree, C., et al. (2004). Factors associated with breast cancer clinical trials participation and enrollment at a large academic medical center. Journal of Clinical Oncology, 22, 2046–2052.CrossRefPubMedGoogle Scholar
- Svensson, K., Ramírez, O. F., Peres, F., Barnett, M., & Claudio, L. (2012). Socioeconomic determinants associated with willingness to participate in medical research among a diverse population. Contemporary Clinical Trials, 33(6), 1197–1205. doi:10.1016/j.cct.2012.07.014.CrossRefPubMedPubMedCentralGoogle Scholar
- Tanai, C., Nokihara, H., Yamamoto, S., Kunitoh, H., Yamamoto, N., Sekine, I., et al. (2009). Characteristics and outcomes of patients with advanced non-small-cell lung cancer who declined to participate in randomized clinical chemotherapy trials. British Journal of Cancer, 100, 1037–1042. doi:10.1038/sj.bjc.6604982.CrossRefPubMedPubMedCentralGoogle Scholar
- Toerien, M., Brookes, S. T., & Metcalfe, C. (2009). A review of reporting of participant recruitment and retention in RCTs in six major journals. Trials, 10, 52. doi:10.1186/1745-6215-10-52.CrossRefPubMedPubMedCentralGoogle Scholar
- Tournoux, C., Katshaian, S., Chevret, S., & Levy, V. (2006). Factors influencing inclusion of patients with malignancies in clinical trials. Cancer, 106, 258–270.CrossRefPubMedGoogle Scholar
- Townsley, C. A., Selby, R., & Siu, L. L. (2005a). Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials. Journal of Clinical Oncology, 23, 3112–3124.CrossRefPubMedGoogle Scholar
- Townsley, C. A., Selby, R., & Siu, L. L. (2005b). Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials. Journal of Clinical Oncology, 23, 3112–3124.CrossRefPubMedGoogle Scholar
- Virani, S., Burke, L., Remick, S. C., & Abraham, J. (2011). Barriers to recruitment of rural patients in cancer clinical trials. Journal of Oncology Practice, 7(3), 172–177. doi:10.1200/JOP.2010.000158.CrossRefPubMedPubMedCentralGoogle Scholar
- Vist, G. E., Hagen, K. B., Devereaux, P. J., Bryant, D., Kristoffersen, D. T., & Oxman, A. D. (2008). Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate. The Cochrane Database of Systematic Reviews, 3, MR000009.Google Scholar
- Walsh, E., & Sheridan, A. (2016). Factors affecting patient participation in clinical trials in Ireland: A narrative review. Contemporary Clinical Trials Communications, 3, 21–31.CrossRefGoogle Scholar