examining the clinical trial feasibility process

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2011 Buress and Sulzer, publisher and licensee Dove Medical Press Ltd. This is an Open Accessarticle which permits unrestricted noncommercial use, provided the oriinal work is properly cited.

Open Access Journal of Clinical Trials 2011:3 5154

Open Access Journal of Clinical Trials

Examinin the clinical trial feasibility processand its implications for a trial site

LJ Buress

NU Sulzer

TREAD Research/Cardioloy Unit,Department of Internal Medicine,

Tyerber Hospital and StellenboschUniversity, Parow, South Africa

Correspondence: LJ BuressTREAD Research/CardioloyUnit, Department of Internal Medicine,Tyerber Hospital and StellenboschUniversity, Parow 7505, South AfricaTel +27 21 931 7825Fax +27 21 933 3597Email [email protected]

Objectives: To retrospectively analyze easibility questionnaires to evaluate the number o

trials that resulted in patient enrolment and the mean time rame involved.

Methods:This study was conducted by TREAD Research, a site-managed organization based

in the Western Cape, South Arica, between January 2004 and December 2009. All easibility

questionnaires received by the site over this time period were analyzed. Descriptive statisticswere used to analyze the data.

Results: A total o 252 easibility questionnaires were received; 207 were accepted and 45

rejected. An average o 26.8% o trials started out o those easibilities that were accepted by the

site. The average time rame rom easibility acceptance to patient enrolment was 12.9 months

(range 2.733.5 months).

Conclusion: Improving the trial easibility process would markedly improve a trial sites ability

to plan eectively and eciently allocate appropriate resources.

Keywords: resource allocation, business planning, clinical research organizations

Introduction

Pharmaceutical companies and clinical research organizations (CROs) typically assessa clinical trial sites potential or patient recruitment through a easibility questionnaire.

Sites are sent a synopsis o the proposed trial and requested to answer various ques-

tions relating to the sites clinical trial experience, its acilities, previous experience

with recruiting or a particular therapeutic area, and its ability to access the required

patient population. Based on these easibilities, sites are chosen to participate in the

proposed trial.

A number o shortalls have been noted in this process. In particular, sites are

requently supplied with a protocol synopsis that does not accurately refect the nal

protocol, and the target patient population is not detailed. This makes subsequent

planning on both the pharmaceutical companys and/or CROs as well as the trial sites

behal, extremely dicult. Another criticism o the easibility process is that it is to alarge extent subjective. Typically, the selection o countries and investigators or clini-

cal trial participation has been based on a combination o unsubstantiated easibility

questionnaires and amiliarity with a core group o investigators.1 Additionally, the

completion o a easibility questionnaire does not guarantee that the trial site will be

awarded the trial and, even i the trial is awarded, no set time rame is provided rom

the completion o the easibility questionnaire to patient enrolment. This act urther

compounds the diculty o planning rom the trial sites perspective.

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Open Access Journal of Clinical Trials 2011:3

ObjectiveThe primary objective o this study was to retrospectively

analyze the easibility questionnaires received by a trial site

in order to: (1) compare those easibilities rejected to those

accepted by the site; and (2) compare easibilities issued by

pharmaceutical companies as opposed to CROs. The sec-

ondary objectives were to: (1) evaluate the number o trials

that resulted in patient enrolment out o the total number o

easibilities received, and (2) assess the mean time rame

rom acceptance o a easibility questionnaire to enrolling

the rst patient.

MethodsThis retrospective analysis was conducted by TREAD Research,

a site-managed organization based within an academic hospital

in the Western Cape, South Arica, between January 2004 and

December 2009. All easibility questionnaires received by the

site over these 6 years were analyzed, and the data were entered

into a Microsot Excel spreadsheet (Microsot, Redmond,

WA). Data captured included year o easibility questionnaire

receipt, the company rom whom the easibility was received

(pharmaceutical company or CRO), whether the easibility

was accepted or rejected by the site, the reason or rejection

(i applicable), and nally those easibilities that resulted in

patient enrolment, including the time rom easibility comple-

tion to rst patient enrolled. Descriptive statistics were used

to analyze the data.

ResultsA total o 252 easibility questionnaires were receivedover the 6-year period. Table 1 presents a summary o the

questionnaires per year according to the number accepted

(n = 207) and those rejected (n = 45). The reasons or easi-

bility rejections included inappropriate therapeutic area or

this trial site (44%), competing studies (31%), pharmaceutical

company/CRO delay (13%), and other (12%).

The percentage o trials that resulted in patient enrolment

rom those easibility questionnaires that were accepted

by the site, per year, is presented in Figure 1. The average

percentage o trials initiated rom those easibilities that

were accepted by the site was 26.8%. A urther analysis

compared the number o trials started rom easibilities

accepted between pharmaceutical companies and CROs.

The data is presented in Figure 2. Pharmaceutical companies

consistently had more trials that resulted in patient enrolment

than CROs.

The nal analysis calculated the mean time rom easibil-

ity return to rst patient enrolled per year, as well as overall

or the 6 years combined. The ndings are presented in

Figure 3. The average combined time rame or the 6 years

was 12.9 months, although this ranged rom a minimum o

2.7 months to a maximum o 33.5 months (2.8 years) rom

easibility return to rst patient enrolled.

DiscussionThe results o this study demonstrate that, at this site, only

a small percentage (26.8%) o easibilities accepted by the

site result in enrolling studies and that the majority o these

trials are initiated by pharmaceutical companies. This study

Table 1 Feasibility questionnaires accepted and rejected by the

trial site per year (n = 252)

Feasibility questionnaires 2004 2005 2006 2007 2008 2009

Feasibilities accepted 25 28 37 48 39 30

Feasibilities rejected 0 8 6 9 14 8

Total feasibilities received 25 36 43 57 53 38

0

20

40

60

80

100

Percentage(%)

2004

Year

20092008200720062005

Figure 1 Percentae of trials started out of those feasibility questionnaires that

were accepted by the site, presented per year.

0

2

4

6

8

10

Numbe

roftrials

2004

Year

Pharmaceutical

CRO

20092008200720062005

Figure 2 Number of trials that resulted in patient enrolment per year for

pharmaceutical companies and CROs.

Abbreviation: CRO,clinical research oranization.


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also demonstrated that the average time rom accepting a

easibility questionnaire to patient enrolment at this site is

12.9 months (range 2.733.5 months).

Clinical trials are becoming more complicated, recruit-

ment requirements are becoming increasingly stringent, and

study budgets are being closely scrutinized; all o these ac-

tors result in a ar more complex environment or trial sites

than ever beore.2,3 Clinical trial sites are arguably rst and

oremost businesses, yet the practical application o nancial

principles and business processes continues to be a challenge

or many trial sites.

The small number o easibilities accepted by the trial

site that result in enrolling studies makes it extremely di-

cult or sites to implement eective recruitment strategies,

and invariably huge administrative and human resources are

wasted. Furthermore, the trial site has little, i any, control

over the decision processes that determine which studies

result in enrolment. Some o the actors which may aect

whether a study at easibility level actually enrolls patients

include the pharmaceutical companys budget changes, drug

or trial timeline delays, a novel agents unexpected and una-

vorable clinical perormance, alterations to a pharmaceutical

companys strategic planning, delays in regulatory approval

processes, and in some instances, ailure on the CROs part

to secure a trial. None o these actors are under the control

and/or infuence o the trial site in any way, yet these deci-

sions play an integral role in the sites recruitment potential

and thereore ultimate nancial survival.

A urther nding o relevance is the average time taken

rom the acceptance o a studys easibility to the enrolment

o the rst patient. The average time or the 6 years combined

was 12.9 months, although this ranged rom a minimum o

2.7 months to a maximum o 33.5 months (2.8 years). This

delay in getting studies initiated, combined with the huge

range in time periods rom study easibility to patient enrol-

ment, renders strategic business planning, budgeting, and

resource allocation almost impossible. This unpredictable

situation also places enormous stress when setting up new

trial sites, as determining time lines, cash fow, and budgets

can almost never be accurate as the actors involved are too

variable.

Arguably, one o the main local determinants in the

lengthy process rom easibility acceptance to patient enrol-

ment has been the regulatory approval process. The Medicines

Control Council has been criticized or its ineciency and

administrative delays in approving clinical trial applications.

Recent developments suggest, however, that these matters are

being addressed and approval timelines are improving. The

data presented in Figure 3 seems to support this and suggests

a trend towards reduced timelines rom 2007. This is o

paramount importance in attracting oreign pharmaceutical

companies to conduct research in South Arica.

South Arica currently enjoys approximately 0.6% o the

world clinical trial market share, with the capacity to increase

to 2.5%. The South Arican Clinical Research Association

estimates that in 2008, approximately R2.2 billion was

generated through conducting internationally sponsored

randomized controlled trials in South Arica.4 Competition

rom other emerging markets such as South America, China,

and emerging Eastern European countries is growing, and

there needs to be a concerted eort as a country to address

any issues that may discourage urther investment in the local

clinical trial industry.

ConclusionThe clinical research process is time and human resource

intensive,3 and the allocation o resources, along with stra-

tegic planning and budgeting, are daily challenges. The

easibility process is a complicated and arguably fawed

one, infuenced by numerous actors, some o which are not

intrinsic to the trial site, yet invariably play a direct role in

determining a trial sites success or ailure. Improving the

trial easibility process and minimizing the range in time lines

between easibility acceptance and patient enrolment would

markedly improve a trial sites ability to plan eectively and

eciently allocate appropriate resources.

DisclosureThe authors report no conficts o interest in this work.

0

5

10

15

20

25

Mean

timeframe(months)

2004

Year

Overall

combined

20092008200720062005

Figure 3 Average time frame (months) from feasibility questionnaire return to rst

patient enrolled per year and overall combined.


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References1. Jones M, Jones S. Data based predictions. Applied Clinical Trials.

March 1, 2008. http://appliedclinicaltrialsonline.indpharma.com/

appliedclinicaltrials/article/articleDetail.jsp?id=500434. Accessed

April 28, 2010.

2. Drayton S, Fraser HE. Five steps to aster recruitment. Good Clin Pract J.

2005 Feb:1720.

3. Snyder A. CTMS can provide business intelligence or sites Applied Clini-

cal Trials. 2010 July 1. http://appliedclinicaltrialsonline.ndpharma.com/

appliedclinicaltrials/Articles/CTMS-Can-Provide-Business-Intelligence-

or-Sites/ArticleStandard/Article/detail/678140. Accessed July 26, 2010.

4. Richardson M-A. Focus on Arica. 2009 Nov. Available rom: http://

www.acro.co.za. Accessed December 2009.


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