Principles and Practice of Pharmaceutical Medicine

(Elle) #1
the cost of processing, packing and shipping the
samples to a central laboratory;

supplies and equipment needed to conduct the
trial;


cost of recruiting subjects;


the amount of screening or ‘prestudy’ work
involved to determine study eligibility and if
the site will be paid for that work, even for
prospects who ultimately fail to qualify for the
study;


personnel costs and time for performing proce-
dures, collecting and forwarding clinical data to
the sponsor or CRO;


records retention fee;


administrative or overhead costs such as rent,
utilities, office supplies.


Many sites report cash flow problems either
because they accepted studies with insufficient
budgets, the sponsor or CRO is very slow to pay
for work already done, or the site failed to negotiate
reimbursement for prestudy work. Regarding slow
pay, a recent study of 111 investigative sites
revealed that 71% of respondents reported that it
is taking ‘somewhat longer’ or ‘much longer’ to
receive payment from sponsors or CROs as
compared to three years earlier (Lamberti, 2005).
There is also research to suggest that prestudy
work can quickly reach $10,000 US before


successful enrollment of the first subject (Silva,
2005), so during the budget negotiation process,
sites should request compensation for screening
costs whether they result in screen failures or sub-
ject enrollment.
If a budget is presented by the sponsor as
‘nonnegotiable’, it is the site’s responsibility to
determine the feasibility of accepting the budget
as is, or attempt to negotiate a few favorable points
such as receiving several thousand dollars in start-
up expenses (Figure 11.7) or adding a line item for
patient recruitment costs.

FDA audits


Clinical sites should be in the habit of operating as
if everyday is inspection day. Operating in top form
is not only in the best interest of the study volun-
teers, it also prepares the sites for FDA inspection,
an inevitability if they are conducting studies for
compounds or devices to be submitted to FDA. The
purpose of inspections is to ensure the protection of
research subjects and the integrity of data sub-
mitted to the agency in support of a marketing
application.
Generally, inspections are done by appointment
and begin with an opening interview with the
investigator and study coordinator(s). The inspec-
torwill tourthe facility, and review charts as wellas
the regulatory binder.
FDA conducts the following three types of
inspections through its Bioresearch Monitoring
Program (Information Sheets, 1998):

Study-oriented

Investigator-oriented

Bioequivalence study.

Thestudy-orientedinspection is conducted almost
exclusively to audit trials that are important to
product evaluation such as NDAs and product
license applications (PLAs) pending before FDA.
The inspection consists of two parts: the facts
surrounding the conduct of the study (Figure 11.8)
and the auditing of study data.


  • Time spent procuring the study, developing a
    proposal and meeting with pre-study site
    selector

  • Preparation of paperwork necessary for the
    study, that is tracking forms and screening forms

  • Regulatory submissions

  • Time spent for study initiation, typically an entire
    day

  • Time spent training hospital staff, nursing and
    pharmacy personnel if study has an inpatient
    component


Figure 11.7 Start-up expenses [Source:Miskin and
Neuer, How to Grow Your Investigative Site, 2002]


11.3 CLINICAL SITE CHALLENGES 135
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