The cost of a study depends on many factors, especially the number of
sites conducting the study, the number of patients required, and
whether the study treatment is already approved for medical use.
Clinical trials follow a standardized process.
The costs to a pharmaceutical company of administering a Phase 3 or 4 clinical trial may include, among others:
- manufacturing the drug(s)/device(s) tested
- staff salaries for the designers and administrators of the trial
- payments to the contract research organization, the site management organization (if used) and any outside consultants
- payments to local researchers (and their staffs) for their time and
effort in recruiting patients and collecting data for the sponsor
- study materials and shipping
- communication with the local researchers, including on-site
monitoring by the CRO before and (in some cases) multiple times during
the study
- one or more investigator training meetings
- costs incurred by the local researchers, such as pharmacy fees, IRB fees and postage
- any payments to patients enrolled in the trial (all payments are
strictly overseen by the IRBs to ensure the patients do not feel coerced
to take part in the trial by overly attractive payments)
These costs are incurred over several years.
In the US, sponsors may receive a 50%
tax credit for certain clinical trials.
[36]
National health agencies, such as the US
National Institutes of Health,
offer grants to investigators who design clinical trials that attempt
to answer research questions of interest to the agency. In these cases,
the investigator who writes the grant and administers the study acts as
the sponsor, and coordinates data collection from any other sites. These
other sites may or may not be paid for participating in the study,
depending on the amount of the grant and the amount of effort expected
from them.
Clinical trials are traditionally expensive and difficult to
undertake. Using internet resources can, in some cases, reduce the
economic burden.
[37]
Investigators
Many clinical trials do not involve any money. However, when the
sponsor is a private company or a national health agency, investigators
are almost always paid to participate. These amounts can be small, just
covering a partial salary for research assistants and the cost of any
supplies (usually the case with national health agency studies), or be
substantial and include 'overhead' that allows the investigator to pay
the research staff during times between clinical trials.
Subjects
Participants in Phase 1 drug trials do not gain any direct benefit
from taking part. They are generally paid an inconvenience allowance
because they give up their time (sometimes away from their homes); the
amounts paid are regulated and are not related to the level of risk
involved. In most other trials, subjects are not paid to ensure their
motivation for participating is the hope of getting better or
contributing to medical knowledge, without their judgment being skewed
by financial considerations. However, they are often given small
payments for study-related expenses such as travel or as compensation
for their time in providing follow-up information about their health
after they are discharged from medical care.
Participation as Labour
It has been suggested that clinical trial participants be considered
to be performing ‘experimental' or 'clinical labour’. Re-classifying
clinical trials as labour is supported by the fact that information
gained from clinical trials contributes to biomedical knowledge,
[38]
and thus increases the profits of pharmaceutical companies. The labour
performed by those participants in clinical trials includes the
provision of tissue samples and information, the performance of other
tasks, such as adhering to a special diet, or (in the case of Phase I
trials particularly) exposing themselves to risk.
[39]
The participants in exchange are offered potential access to medical
treatment. For some, this may be a treatment with the potential to
succeed where other treatments have failed. For other individuals,
particularly those situated in countries such as China or India, they
may be given access to healthcare which they otherwise would be unable
to afford, for the duration of the trial.
[40][41][42] Thus, the exchange which exists may serve to classify clinical trials as a form of labour.
Participating in a clinical trial
Phase 0 and Phase 1 drug trials seek healthy volunteers. Most other
clinical trials seek patients who have a specific disease or medical
condition. The diversity observed in society, by consensus, should be
reflected in clinical trials through the appropriate inclusion of
ethnic minority populations.
[43]Patient recruitment plays a significant role in the activities and responsibilities of sites conducting clinical trials.
Locating trials
Depending on the kind of participants required, sponsors of clinical
trials use various recruitment strategies, including patient databases,
newspaper and radio advertisements, flyers, posters in places the
patients might go (such as doctor's offices), and personal recruitment
of patients by investigators.
Volunteers with specific conditions or diseases have additional
online resources to help them locate clinical trials. For example,
people with Parkinson's disease can use
PDtrials to find up-to-date information on
Parkinson's disease
trials currently enrolling participants in the US and Canada, and
search for specific Parkinson's clinical trials using criteria such as
location, trial type, and symptom.
[44] Other disease-specific services exist for volunteers to find trials related to their condition.
[45] Volunteers may search directly on
ClinicalTrials.gov to locate trials using a registry run by the
U.S. National Institutes of Health and
National Library of Medicine.
However, many clinical trials will not accept participants who
contact them directly to volunteer, as it is believed this may bias the
characteristics of the population being studied. Such trials typically
recruit via networks of medical professionals who ask their individual
patients to consider enrollment.
[citation needed]
Steps for volunteers
Before participating in a clinical trial, interested volunteers
should speak with their doctors, family members, and others who have
participated in trials in the past. After locating a trial, volunteers
will often have the opportunity to speak or e-mail the clinical trial
coordinator for more information and to answer any questions. After
receiving consent from their doctors, volunteers then arrange an
appointment for a screening visit with the trial coordinator.
[46]
All volunteers being considered for a trial are required to undertake
a medical screening. Requirements differ for different trials, but
typically volunteers will have the following tests in a
medical laboratory:
[47]
- Measurement of the electrical activity of the heart (ECG)
- Measurement of blood pressure, heart rate and temperature
- Blood sampling
- Urine sampling
- Weight and height measurement
- Drugs abuse testing
- Pregnancy testing (females only)
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. Web-based
electronic data capture (EDC) and
clinical data management systems are used in a majority of clinical trials
[48] 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).
Patient-reported outcome measures are being increasingly collected using hand-held, sometimes wireless
ePRO (or eDiary) devices.
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.
Controversy
In 2001, the editors of 12 major journals issued a joint editorial,
published in each journal, on the control over clinical trials exerted
by sponsors, particularly targeting the use of contracts which allow
sponsors to review the studies prior to publication and withhold
publication. They strengthened editorial restrictions to counter the
effect. The editorial noted that
contract research organizations had, by 2000, received 60% of the grants from
pharmaceutical companies
in the US. Researchers may be restricted from contributing to the trial
design, accessing the raw data, and interpreting the results.
[49]
Seeding trials are particularly controversial.
[50]