Clinical trials designed by a local investigator, and (in the US)
federally funded clinical trials, are almost always administered by the
researcher who designed the study and applied for the grant. Small-scale
device studies may be administered by the sponsoring company. Clinical
trials of new drugs are usually administered by a
contract research organization
(CRO) hired by the sponsoring company. The sponsor provides the drug
and medical oversight. A CRO is contracted to perform all the
administrative work on a clinical trial. For phases 2, 3 and 4, the CRO
recruits participating researchers, trains them, provides them with
supplies, coordinates study administration and data collection, sets up
meetings, monitors the sites for compliance with the clinical protocol,
and ensures the sponsor receives data from every site. Specialist
site management organizations
can also be hired to coordinate with the CRO to ensure rapid IRB/IEC
approval and faster site initiation and patient recruitment. Phase 1
clinical trials of new medicines are often conducted in a specialist
clinical trial clinic, with dedicated pharmacologists, where the
subjects can be observed by full-time staff. These clinics are often run
by a CRO which specialises in these studies.
At a participating site, one or more research assistants (often
nurses) do most of the work in conducting the clinical trial. The
research assistant's job can include some or all of the following:
providing the local
institutional review board
(IRB) with the documentation necessary to obtain its permission to
conduct the study, assisting with study start-up, identifying eligible
patients, obtaining consent from them or their families, administering
study treatment(s), collecting and statistically analyzing data,
maintaining and updating data files during followup, and communicating
with the IRB, as well as the sponsor and CRO.
Marketing
Janet
Yang uses the Interactional Justice Model to test the effects of
willingness to talk with a doctor and clinical trial enrollment.
[45]
Results found that potential clinical trial candidates were less likely
to enroll in clinical trials if the patient is more willing to talk
with their doctor. The reasoning behind this discovery may be patients
are happy with their current care. Another reason for the negative
relationship between perceived fairness and clinical trial enrollment is
the lack of independence from the care provider. Results found that
there is a positive relationship between a lack of willingness to talk
with their doctor and clinical trial enrollment. Lack of willingness to
talk about clinical trials with current care providers may be due to
patients’ independence from the doctor. Patients who are less likely to
talk about clinical trials are more willing to use other sources of
information to gain a better insight of alternative treatments. Clinical
trial enrollment should be motivated to utilize websites and television
advertising to inform the public about clinical trial enrollment.
Information technology
The last decade has seen a proliferation of
information technology use in the planning and conduct of clinical trials.
Clinical trial management systems
are often used by research sponsors or CROs to help plan and manage the
operational aspects of a clinical trial, particularly with respect to
investigational sites. Advanced analytics for identifying researchers
and research sites with expertise in a given area utilize public and
private information about ongoing research.
[46] Web-based
electronic data capture (EDC) and
clinical data management systems are used in a majority of clinical trials
[47] to collect case report data from sites, manage its quality and prepare it for analysis.
Interactive voice response
systems are used by sites to register the enrollment of patients using a
phone and to allocate patients to a particular treatment arm (although
phones are being increasingly replaced with web-based (IWRS) tools which
are sometimes part of the EDC system). While
patient-reported outcome were often paper based in the past, measurements are increasingly being collected using web portals or hand-held
ePRO (or eDiary) devices, sometimes wireless.
[48] Statistical software
is used to analyze the collected data and prepare them for regulatory
submission. Access to many of these applications are increasingly
aggregated in web-based
clinical trial portals.
In 2011, the FDA approved a phase 1 trial that used telemonitoring,
also known as remote patient monitoring, to collect biometric data in
patients' homes and transmit it electronically to the trial database.
This technology provides many more data points and is far more
convenient for patients, because they have fewer visits to trial sites.
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