Describe about the Site Selection Criteria and Process in Clinical Research?
Success of the clinical research is significantly reliant on the effective site selection. Site refers to the hospital, laboratory or health care setting where the research will be conducted. A proactive planning and identification of the appropriate site selection criteria can be helpful in ensuring success of the clinical trial (Warden et al., 2012). There are various factors that influence the site planning. Recognizing those elements will contribute in discussion of the site selection criteria and procedure for clinical research. The successful site performance can be equated with the potential for delivering qualified subjects along with evaluation of data which have a significant impact on the research outcomes (Harper and Zuckerman, 2006). This paper will focus on analyzing the appropriate site selection criteria along with its procedure.
First of all, it must be noted that there is no ideal site for the clinical research. The researcher needs to outline the required qualities for that specific research. It is important to match the requirements or need of that particular clinical study with the characteristics of the study. One of the most important factors is the experience and qualification of the researcher along with the research staffs for selection of a site. Technical experts must be appointed for indentifying the technical requirements and facilities. Therefore, the researcher must focus on the site experience i.e. the area of clinical research and the therapeutic area (Harper and Zuckerman, 2006). Another important factor that needs to be analyzed is the staffing, workload, resources along with the time commitment of that particular site. The next important thing which needs to be taken into consideration is the interest and enthusiasm of the site for conducting the clinical research. It is essential to analyze the skills along with the potential of the personnel for this study. Staff turnover rates must be considered as high staff turnover rate may lead to problem for the clinical study (Horsburgh et al., 2013). The functional responsibilities of the site personnel must be analyzed in before selecting the site. The patient population must be studied and need to be compared with the requirement of the clinical study (Kawamoto, 2005). One of the important selection criteria is the technical feasibility and availability of the required equipments. The researcher is responsible for ensuring that the site meets the subject diversity requirements. If the staffs of the site are found to be friendly and customer oriented, it will be favorable for the study. Subject friendly facilities are essential for conducting the clinical study. Financial constraints of a clinical trial or research must be considered at the time of site selection. Hence, the clinical study budget must be fair and reasonable (Maggon, 2004). The policies and procedures of the ethical review committee must be reviewed. Moreover, the legal procedures of that institution must be analyzed as it is essential to comply with those rules. Operational procedures along with training process at the site must be evaluated as it is one of the most important site selection criteria for clinical research. Audit and GCP compliance history must be reviewed by the site selection committee (Mollon et al., 2009). Another significant criterion is the flexibility of the clinic hours of that hospital. Moreover, the security system and storage facilities of the site need to be scrutinized to ensure appropriate system for the clinical research.
These are the principle factors that need to be analyzed at the time of site selection of a clinical research. It is important to match the research requirements with the characteristics of the site on the basis of the discussed factors (The Lancet, 2012). Therefore, the sites will be rated as per matching the research criteria and the site having higher level of competency in terms of the above stated factors, final decision will be taken (Gehring et al., 2013).
Conclusion
This paper has provided an in depth idea relating to the selection criteria of the site. It is evident that the selection of an appropriate site for clinical research is crucial to its success. Hence, the researchers have focused on designing a procedure for selecting suitable site on the basis of some predetermined selection criteria. The selection criteria will be developed on the basis of nature and requirement of the research. This paper has identified that site experience and interest of the site for conducting research will be considered as major criteria for selecting site. The potential, skills and turnover of human resources are recognized as significant criteria. Additionally, technical feasibility, compliance with legal requirements, security system etc are important factors for selecting site for clinical research.
References
Gehring, M., Taylor, R., Mellody, M., Casteels, B., Piazzi, A., Gensini, G. and Ambrosio, G. (2013). Factors influencing clinical trial site selection in Europe: the Survey of Attitudes towards Trial sites in Europe (the SAT-EU Study). BMJ Open, 3(11), pp.e002957-e002957.
Harper, B. and Zuckerman, D. (2006). Critical Success Factors for Planning for Site Selection and Patient Recruitment Planning. BioExecutive International, 2(6), pp.16-28.
Horsburgh, D., Lansang, E., Lee, K., Lee, J., Ogg, M. and Wai, K. (2013). Growing risk avoidance in Asian oncology site selection: how trends in site selection are limiting growth of the Asia cancer trial landscape. OAJCT, p.1.
Kawamoto, K. (2005). Improving clinical practice using clinical decision support systems: a systematic review of trials to identify features critical to success. BMJ, 330(7494), pp.765-0.
Maggon, K. (2004). Investigator and site selection and performing GCP clinical studies in India.Controlled Clinical Trials, 25(4), pp.366-377.
Mollon, B., Chong, J., Holbrook, A., Sung, M., Thabane, L. and Foster, G. (2009). Features predicting the success of computerized decision support for prescribing: a systematic review of randomized controlled trials. BMC Med Inform Decis Mak, 9(1), p.11.
The Lancet, (2012). Clinical research in Europe—trials and tribulations. The Lancet, 379(9828), p.1764.
Warden, D., Trivedi, M., Greer, T., Nunes, E., Grannemann, B., Horigian, V., Somoza, E., Ring, K., Kyle, T. and Szapocznik, J. (2012). Rationale and methods for site selection for a trial using a novel intervention to treat stimulant abuse. Contemporary Clinical Trials, 33(1), pp.29-37.
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