Review Articles

Study Coordination and its key role in Clinical Research

Main Article Content

Inês Zimbarra Cabrita
Francisca Patuleia Figueiras
Margarida Nogueira
Susana Silva
Cecília Gomes
Fausto J. Pinto
Clinical Trials, Clinical Protocols, Research Personnel, Ensaios Clínicos; Equipa de Investigação; Investigação Biomédica; Protocolos Clínicos


We have been seeing a growing body of work showing the benefits of having health institutions investing in clinical research – health outcomes appear to be better, following of guidelines, and consequent patient care are also improved. The existence of a Clinical Research Support Unit seems essential, ensuring patient safety and quality of data, by supporting with time-consuming and expertise-requiring tasks. The inclusion of a Clinical Research Coordinator is thought to carry many advantages, as a considerable amount of responsibilities will be delegated to this professional.

This review adds onto the current literature on the role a Clinical Research Support Unit and a Clinical Research Coordinator have on clinical research, as well as the benefits they bring.

A strong unit gives rise to efficient, quality research, which in turn leads to improved, optimally delivered healthcare services, improved outcomes, enhanced infrastructures, job creation, and cost savings. The presence of a Clinical Research Support Unit with a professional Clinical Research Coordinator team not only facilitates industry-sponsored research but also enables the development of investigator-initiated studies. Further studies on the medical and socio-economic effects of high-quality clinical research activity in Portugal are both justified and necessary.

Article Details

How to Cite
Review Articles


Bois A du, Rochon J, Lamparter C, PFisterer J. Pattern of care and impact of participation in clinical studies on the outcome in ovarian cancer. Int J GynecolCancer. 2005;15:183-91. doi:10.1111/j.1525-1438.2005.15202.x

Majumdar SR. Better Outcomes for Patients Treated at Hospitals That Participate in Clinical Trials. Arch Intern Med. 2008;168:657. doi:10.1001/archinternmed.2007.124

Downing A, Morris EJ, Corrigan N, Sebag-Montefiore D, Finan PJ, Thomas JD,

et al. High hospital research participation and improved colorectal cancer survival outcomes: a population-based study. Gut. 2017;66:89-96. doi:10.1136/gutjnl-2015-311308

Nijjar S, D’Amico M, Wimalaweera N, Cooper N, Zamora J, Khan K. Participation in clinical trials improves outcomes in women’s health: a systematic review and meta-analysis. BJOG. 2017;124:863-71. doi:10.1111/1471-0528.14528

Karjalainen S, Palva I. Do treatment protocols improve end results? A study of survival of patients with multiple myeloma in Finland. BMJ. 1989;299:1069-72. doi:10.1136/bmj.299.6707.1069

Clarke M, Loudon K. Effects on patients of their healthcare practitioner’s or institution’s participation in clinical trials: a systematic review. Trials. 2011;12:16. doi:10.1186/1745-6215-12-16

Rochon J, du Bois A, Lange T. Mediation analysis of the relationship between institutional research activity and patient survival. BMC Med Res Methodol. 2014;14:9. doi:10.1186/1471-2288-14-9

Seruga B, Sadikov A, Cazap EL, Delgado LB, Digumarti R, Leighl NB,

et al. Barriers and Challenges to Global Clinical Cancer Research. Oncologist. 2014;19:61-7. doi:10.1634/theoncologist.2013-0290

Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to Participation in Randomised Controlled Trials. J Clin Epidemiol. 1999;52:1143-56. doi:10.1016/S0895-4356(99)00141-9

Sumi E, Murayama T, Yokode M. A survey of attitudes toward clinical research among physicians at Kyoto University Hospital. BMC Med Educ. 2009;9:75. doi:10.1186/1472-6920-9-75

Chen DT. Clinical Research and the Physician–Patient Relationship. Ann Intern Med. 2003;138:669. doi:10.7326/0003-4819-138-8-200304150-00015

Dev AT, Kauf TL, Zekry A, Patel K, Heller K, Schulman KA,

et al. Factors influencing the participation of gastroenterologists and hepatologists in clinical research. BMC Health Services Research. 2008;8:208. doi:10.1186/1472-6963-8-208

Yanagawa H, Kishuku M, Akaike M, Azuma H, Irahara M. View of physicians on and barriers to patient enrollment in a multicenter clinical trial: experience in a Japanese rural area. Int Arch Med. 2010;3:7. doi:10.1186/1755-7682-3-7

Albers LL, Sedler KD. Clinician perspectives on participation in research. J Midwifery Womens Health. 2004;49:47-50. doi: 10.1016/j.jmwh.2003.09.013.

Gawlinski A. The Power of Clinical Nursing Research: Engage Clinicians, Improve Patients’ Lives, and Forge a Professional Legacy. Am J Critical Care. 2008;17:315-26. doi:10.4037/ajcc2008.17.4.315

Yanos PT, Ziedonis DM. The Patient-Oriented Clinician-Researcher: Advantages and Challenges of Being a Double Agent. Psychiatric Serv. 2006;57:249-53. doi:10.1176/

Albers LL, Sedler KD. Clinician perspectives on participation in research. J Midwifery Womens Health. 2004;49:47-50. doi: 10.1016/j.jmwh.2003.09.013.

Taylor KM. Integrating conflicting professional roles: Physician participation in randomized clinical trials. Soc Sci Med. 1992;35:217-24. doi:10.1016/0277-9536(92)90169-Q

Rahman S, Majumder MA, Shaban SF, Rahman N, Ahmed M, Abdulrahman KB, et al. Physician participation in clinical research and trials: issues and approaches. Adv Med Educ Pract. 2011;2:85-93. doi: 10.2147/AMEP.S14103.

Rubio DM, Primack BA, Switzer GE, Bryce CL, Seltzer DL, Kapoor WN. A Comprehensive Career-Success Model for Physician–Scientists. Acad Med. 2011;86:1571-6. doi:10.1097/ACM.0b013e31823592fd

Croghan IT, Viker SD, Limper AH, Evans TK, Cornell AR, Ebbert JO, et al. Developing a clinical trial unit to advance research in an academic institution. Contemp Clin Trials. 2015;45:270-6. doi: 10.1016/j.cct.2015.10.001.

Cimino J, Braun C. Building a competitive infrastructure to support clinical research in healthcare institution. Eur J Clin Invest. 2021;51(9). doi:10.1111/eci.13641

Divate U, Divate P, Bhosale N, Das S. Best practices sharing: Setting up a professional clinical research unit in India. Perspect Clin Res. 2014;5:37. doi:10.4103/2229-3485.124570

Pelke S, Easa D. The Role of the Clinical Research Coordinator in Multicenter Clinical Trials. J ObstetGynecolNeonatal Nurs. 1997;26:279-85. doi:10.1111/j.1552-6909.1997.tb02143.x

Annahern J, Kruger DF, Gatcomb PM, Petit WA, Tamborlane WV. The Diabetes Control and Complications Trial (DCCT): The Trial Coordinator Perspective. Diabetes Educ. 1989;15:236-41. doi:10.1177/014572178901500313

Mullin SM, Warwick S, Akers M, Beecher P, Helminger K, Moses B, et al. An acute intervention trial: the research nurse coordinator's role. Control Clin Trials. 1984;5:141-56. doi: 10.1016/0197-2456(84)90120-x.

Ahern J, Grove N, Strand T, Wesche J, Seibert C, Brenneman AT, et al. The impact of the Trial Coordinator in the Diabetes Control and Complications Trial (DCCT). The DCCT Research Group. Diabetes Educ. 1993;19:509-12. doi: 10.1177/014572179301900606.

World Medical Association Declaration of Helsinki. JAMA. 2013;310:2191. doi:10.1001/jama.2013.281053

Larkin ME, Lorenzi GM, Bayless M, Cleary PA, Barnie A, Golden E, et al. Evolution of the study coordinator role: the 28-year experience in Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC). Clin Trials. 2012;9:418-25. doi: 10.1177/1740774512449532.

European Medicines Agency. Guideline on the Content, Management and Archiving of the Clinical Trial Master File. 2017.[accessed Dez 2021] Available from:

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) ICH Harmonised Guideline Integrated Addendum to ICH E6(R1): guideline for good clinical practice E6(R2). London: ICH; 2016.

European Medicines Agency. Audit Checklist Interpretation Guide. [accessed Dez 2021] Available from:

Bentley C, Cressman S, van der Hoek K, Arts K, Dancey J, Peacock S. Conducting clinical trials—costs, impacts, and the value of clinical trials networks: A scoping review. Clin Trials. 2019;16:183-93. doi:10.1177/1740774518820060

Konwar M, Bose D, Gogtay NJ, Thatte UM. Investigator-initiated studies: Challenges and solutions. Perspect Clin Res. 9:179-83. doi:10.4103/picr.PICR_106_18

Selby P, Kaplan R, Cameron D, Cooper M, Seymour M. The Royal College of Physicians Simms Lecture, 6 December 2011: Clinical research networks and the benefits of intensive healthcare systems. Clin Med. 2012;12:446-52. doi:10.7861/clinmedicine.12-5-446

Janni W, Kiechle M, Sommer H, Rack B, Gauger K, Heinrigs M, et al; ADEBAR Study Group. Study participation improves treatment strategies and individual patient care in participating centers. Anticancer Res. 2006;26:3661-7.

van Gijn W, Krijnen P, Lemmens VE, den Dulk M, Putter H, van de Velde CJ. Quality assurance in rectal cancer treatment in the Netherlands: A catch up compared to colon cancer treatment. Eur J Surg Oncol. 2010;36:340-4. doi:10.1016/j.ejso.2009.10.010

Krzyzanowska MK, Kaplan R, Sullivan R. How may clinical research improve healthcare outcomes? Ann Oncol. 2011;22:vii10-vii15. doi:10.1093/annonc/mdr420

KPMG. Impact and Value of the NIHR Clinical Research Network - Financial Years 2016/17-2018/19. Amstelveen: KPMG; 2019.

Rocha C, Serras R. Ensaios Clínicos em Portugal. Lisboa: Apifarma; 2019.