Economics

Sponsor

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 expenses incurred by a pharmaceutical company in administering a phase 3 or 4 clinical trial may include, among others:

• production of the drug(s) or device(s) being evaluated
• 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 test subjects and collecting data for the sponsor
• the cost of study materials and the charges incurred to ship them
• 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
• expense incurred by the local researchers, such as pharmacy fees, IRB fees and postage
• any payments to subjects enrolled in the trial (all payments are strictly overseen by the IRBs to ensure the amount of remuneration offered to test subjects does not entice anyone to participate in the trial)
• the expense of treating a test subject who develops a medical condition unrelated to that being targeted by the study drug, but caused by the study drug

These expenses are incurred over several years.
In the USA, sponsors may receive a 50 percent tax credit for clinical trials conducted on drugs being developed for the treatment of orphan diseases.^[65] 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.^[66] New technologies enable sponsors and CRO's to reduce trial costs by executing online feasibility assessments and better collaborate with research centers such as ViS Research Institute.

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,^[67] 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.^[68] 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.^[69][70][71] Thus, the exchange which exists may serve to classify clinical trials as a form of labour.