Clinical Research Site Selection: Criteria, Process, and Evaluation

This report provides an in-depth discussion on clinical trial site selection, emphasizing its critical role in research success. It outlines a structured process involving site awareness, screening, evaluation, and final selection, ensuring the chosen site meets specific criteria. The criteria for site selection are detailed, including the qualifications of personnel, site suitability (accessibility, facilities, and past performance), availability of a suitable patient population, and economic considerations to ensure cost-effectiveness. The report underscores the importance of adhering to these criteria and processes to enhance data quality, meet recruitment targets, and ultimately, contribute to advancements in healthcare. The conclusion reiterates the significance of site selection in clinical trials, advocating for a standardized procedure and strict adherence to criteria to achieve research objectives and improve healthcare outcomes.

1
Clinical Research Site Selection Criteria and Process
Name
Lecturer
Course
Date

2
Clinical Research Site Selection Criteria and Process
Introduction
Clinical trial is an important activity that should always be supported because it is
conducted for the right purpose. For as clinical trial to be a success, it should be done by
following some procedures. It is a complex undertaking that involves different kinds of activities
such as site identification and selection. Site selection is, therefore, one of the most essential
processes in the clinical trial. When given a responsibility to undertake a clinical trial, it is
commendable to use the right criteria of site selection because it is what can determine the
overall success of the entire process. The purpose of this paper is to present an in-depth and
critical discussion on clinical trial site selection.
Site Selection
Site selection is the process of identifying and choosing a place in which a clinical trial
should be conducted. It is an important activity that must be done during clinical trial because
without it, it might not be possible to achieve anything. Meaning, it is a essential activity that
must be taken seriously during the process of clinical trial. The benefit of site selection is that it
enables the researchers to choose the most suitable site where the trial can be conducted with
ease (4, p. 343). A proper site selection is required for a clinical trial because it can be relied
upon to improve the quality of data and to accomplish the recruitment target for the trial. Despite
the significant role of clinical site, there is no research that has been conducted to provide a
conclusive decision on the best model of site selection to adopt during the trial. However, this
paper focuses on two issues regarding site selection-process and criteria.
The Process of Site Selection

3
The choice of a site is a key component of clinical trial. For it to succeed in realizing its
goals, the process of site selection must be done by following a well-organized procedure. Each
and every activity must be done at the right time because any mishaps might be undesirable since
it might distort the outcome of the trial (5, p. 1). In this regard, when engaging in a clinical trial,
the following procedure must be followed adhered to in order to ensure that the most appropriate
site is selected.
The first stage in the process of site selection should involve the building of awareness
amongst the potential sites that should be incorporated into the trial. Here, what needs to be done
is the identification of the various sites which exist and can be used for the study. Once the
potential sites are identified, they need to be informed and equipped with information on the
planned trial that is to be conducted (6, p. 137). Information provision is core because it prepares
the site and equips it with all the information that it needs to know about the planned trial, its
significance, organization, and anything else about it.
The second stage in the process of site selection entails the screening of the identified
sites that are to be used in the study. The screening process can be done by conducting a survey
through which the suitability of the site is determined. The survey can be done by using
questionnaires and interviews to collect data that can be used to ascertain if the identified sites
are suitable for the trial (7, p. 1). To determine the suitability of a site, various questions can be
asked. Such questions can be about the level of care at the facility, patient population served, and
staffing levels. Willingness to participate in the trial is also questioned.
The third stage in the process of site selection is called evaluation. As its name suggests,
evaluation simply refers to assessment. Here, the identified sites are assessed to identify the best

4
one that deserves to be used in the trial. During the evaluation process, there are many factors
that are considered to ensure that the trial is conducted in the most appropriate site (8, p. 1579).
Among the factors that can qualify a site for selection include the capacity of the site, patient
population, staffing levels, and the cost-effectiveness of the site. It is only the site that meets all
the set criteria that qualifies for selection and usage in the trial.
The fourth and the last stage in the process of site selection is the identification of the
proposed site. During this stage, what happens is that the available data that has already been
evaluated is analyzed in order to narrow down the search to one site that is the most suitable for
use in the trial. If the available data qualifies one given site, it is the one that should be selected
and used for the trial (10, p. 182). However, for this to be successfully done, the evaluation and
selection process should be objectively and transparently done to ensure that only one site that
best fits is selected. That is the only way through which the researchers can get an opportunity to
conduct the study on the best site of all.
The Criteria for Site Selection
As already hinted, site selection is one of the core components of clinical trial. Whenever
engaging in such a study, it is incumbent upon the researchers to choose the most appropriate site
in which the trial should be conducted. The suitability of the site means a lot to the trial process
because it is what determines its eventual success. Therefore, apart from considering the process
of site selection, the researchers must, at all times, put into account the criteria for the same.
Meaning, they must take all the necessary measures to ensure that the chosen site meets the
required criteria (9, p. 17). Having said this, it is important to acknowledge that the selection of
the site should be based on the following factors:

5
First and foremost, the selection of the trial site should be done by considering the
qualifications of the personnel to involve in the study. Just like any other research, clinical trial is
supposed to be handled in a professional manner. Meaning, it should be done by a team of
highly-trained, qualified, and experienced staff who have a sound knowledge of what it entails
(2, p. 1117). This is, therefore, one of the fundamental factors to be considered when choosing
site to be used for a clinical study since it can play a significant role in determining the success
of trial and accomplishment of its goals.
Secondly, the selection of a clinical trial site should be pegged on the suitability of the
site itself. As a matter of fact, all the sites cannot be suitable for a clinical trial. Meaning, there
are only specific ones that meet certain criteria that can be chosen and used for the study. Hence,
when making that choice, there are certain criteria that must be observed (3, p. 1). Most
importantly, the chosen site must be accessible and have all the required facilities that can be
used during the trial process. Meaning, it should, among other things, have the right equipments
and facilities that can help in facilitating the trial process. At the same time, such a study should
have a good track record of aiding such trials in the past. That is the only way through which it
can be trusted for usage in the study.
Thirdly, the selection of a clinical trial site should be influenced by the availability of a
patient population that can be used for the study. Although the trial process is done by the
leading team and the staff, it must also involve the patients because they are the ones on whom
the entire study would be conducted. Meaning, the patients participate in the study as participants
whose input is also necessary just like the other participants (2, p. 1117). The patient is,
therefore, an important factor that must be considered because it means that the trial should only
be carried out at a site where there is enough patient population to be relied upon.

6
Finally, the selection of a clinical trial site should be influenced by economic factors.
Whenever engaging in a clinical trial, all the necessary measures should be made to ensure that it
is economical. Meaning, despite consuming some money, it should be cost-effective. An
economically viable trial should not be too much costly, but affordable as much as possible (1, p.
6562). It should not constrain the budget and make it difficult for the team to implement it. This
can be accomplished by choosing site which has all the required facilities and can be easily
accessed by the researchers during the entire period of the trial. If this is done, the trial can run
smoothly without facing any unnecessary financial hiccups.
Conclusion
Clinical trial is an important activity that must always be supported because it is done for
the benefit of the larger public. The data generated during the trial can be used to make important
decisions aimed at improving the quality of healthcare services in the country. Hence, when
conducting the trial, it is worth to follow a standard procedure and make all the necessary
considerations geared towards the accomplishment of set objectives. Site selection, as one of the
core activities in the clinical trial process should, therefore, be conducted by following the right
procedure and in a strict compliance with set criteria.

7
Bibliography
1. Ambroise C, McLachlan GJ. Selection bias in gene extraction on the basis of microarray
gene-expression data. Proceedings of the national academy of sciences. 2002 May
14;99(10):6562-6.
2. Allcott H. Site selection bias in program evaluation. The Quarterly Journal of Economics.
2015 Mar 18;130(3):1117-65.
3. Chow SC, Shao J, Wang H, Lokhnygina Y. Sample size calculations in clinical research.
Chapman and Hall/CRC; 2017 Aug 15.
4. Dziura JD, Post LA, Zhao Q, Fu Z, Peduzzi P. Strategies for dealing with missing data in
clinical trials: from design to analysis. The Yale journal of biology and medicine. 2013
Sep; 86 (3):343.
5. Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB. Designing clinical
research. Lippincott Williams & Wilkins; 2013 May 8.
6. Gheorghiade M, Vaduganathan M, Greene SJ, Mentz RJ, Adams KF, Anker SD, Arnold
M, Baschiera F, Cleland JG, Cotter G, Fonarow GC. Site selection in global clinical trials
in patients hospitalized for heart failure: perceived problems and potential solutions.
Heart failure reviews. 2014 Mar 1;19(2):135-52.
7. Gehring M, Taylor RS, Mellody M, Casteels B, Piazzi A, Gensini G, Ambrosio G.
Factors influencing clinical trial site selection in Europe: the Survey of Attitudes towards
Trial sites in Europe (the SAT-EU Study). BMJ open. 2013 Nov 1;3 (11):e002957.
8. Lauer MS, D’Agostino Sr RB. The randomized registry trial—the next disruptive
technology in clinical research. N Engl J Med. 2013 Oct 24; 369 (17):1579-81.

8
9. Overman MJ, Modak J, Kopetz S, Murthy R, Yao J, Hicks ME, Abbruzzese JL, Tam AL.
The use of research biopsies in clinical trials: are risks and benefits adequately discussed?
Journal of clinical oncology: official journal of the American Society of Clinical
Oncology. 2013 Jan 1; 31 (1):17.
10. Phillips SJ, Dudík M, Elith J, Graham CH, Lehmann A, Leathwick J, Ferrier S. Sample
selection bias and presence‐only distribution models: implications for background and
pseudo‐absence data. Ecological applications. 2009 Jan 1;19 (1):181-97.