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 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)
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
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]
