How Much Do Clinical Trials Pay?
Participants in clinical trials need to be compensated. This compensation is paid to the research subjects with two main aims – for participating in the trial itself and as compensation for any injuries sustained due to the trial.
Clinical trial compensation can be either monetary or non-monetary.
Monetary benefits compensate for the time and effort of the participants, covering expenses such as travel, loss of daily wages, etc., and for any injuries sustained from the clinical trial.
Compensation for a clinical trial may include coverage of medical treatment for problems or injuries arising from the trial.
In this article, we will consider the practical aspect of participant compensation, tips on when to offer compensation for clinical trials, the compensation payment method and different modes of compensation used today.
Practical Need for Clinical Trial Compensation
When you decide to compensate participants for their time invested in a clinical trial, you will normally get a higher number of applications and fewer drop-outs, and it also helps to decrease study timelines.
Moreover, practical aspects include the need for administrative resources to process and deliver compensation, collect tax information such as social security numbers and postal addresses, and ensure the participant receives the compensation.
Sponsors should be aware that any form of monetary compensation is likely to have tax implications for the participants, thus you may need to collect and store the participants’ tax details.
There could arise some situations where participants under government welfare programs or collecting disability benefits may have their benefit amount reduced.
This is a major concern for research scientists because this phenomenon may adversely affect the participant’s financially vulnerable situation.
When to offer Clinical Trial Compensation?
Due to the lack of uniform standards across the industry, trial sponsors generally make these decisions independently.
According to the World Health Organization (WHO) and Council for International Organization of Medical Sciences (CIOMS) guidelines, reimbursement and compensation for participants in clinical trials should always be offered in observational and interventional research studies.
In situations with potential health benefits for the participants, the trial sponsor needs to compensate the participants for the inconvenience caused by their involvement.
CIOMS also advises that compensation be worth the time and inconvenience experienced by the participants, as opposed to the risk associated with their participation.
Studies with high-risk factors should avoid compensating with amounts that might influence participants to make poor judgments.
These criteria of compensation serve as the template for trial sponsors to determine the value of compensation for trial participants. You can choose to mark participation as enrolment expense as it becomes easier to gauge its impact on the participant.
It is essential to obtain IRB and other ethical approvals for the proposed compensation method before starting the research study or trial.
Modes of Compensation for Clinical Trial Participants
The process of delivering the compensation to participants usually requires extensive administrative support from the site staff.
It is not advisable to assign compensation tasks to an administrative assistant or research coordinator without fully understanding the time required to complete the process successfully, as this can often lead to delayed payments.
This may, in turn, result in jeopardizing the relationship between trial sponsors and the research subjects.
To create the most effective and convenient compensation plan for clinical trial participants, find out the answers to the below-given questions:
- What form of compensation is being offered?
- What are the resources in place to support the reimbursement process?
- How will the compensation amount be delivered to participants?
- Is collecting and reporting tax information, such as social security numbers, essential?
- Who will be tasked to collect personal information, such as a postal address, etc., from participants?
- What will happen if a participant claims they did not receive the compensation promised to them?
In short, you will need to decide how the compensation will be paid – whether in cash, check, electronic or physical gift cards, if existing Accounts Payable departments and specific processes are in place for compensation reimbursement, whether the compensation will be delivered to the participant via mail, email or in-person, etc.
The sample size of the proposed trial will also impact these factors and affect the resources and time required to complete the compensation process.
Best Way to Compensate for Clinical Trials
These are the standard models of compensation used in the industry currently:
1 – The Market Model
This is based on supply and demand where compensation is decided according to local standards. This answers what, when and how much compensation is offered as well as makes it easier to find qualified participants. The more difficult it is to find participants, the higher is the sum offered.
2 – The Wage Model
This is based on algorithmic factors and offers the same compensation to all participants. Under this, participation is regarded as akin to a job that requires unskilled labor. Thus, compensation rates are similar to industrial minimum wages regarding local conditions.
As of the last update, the federal minimum wage in the US is $7.25 per hour, but state minimum wages may be higher.
3 – The Reimbursement Model
This model dictates that participants are compensated for the expenses incurred during the trial period. This may include the cost of traveling, parking and food. Sometimes, this compensation model also covers lost wages if a participant had to take time off work to participate in the clinical trial.
Participants must keep track of all trial-related expenses and submit receipts for reimbursement.
4 – The Appreciation Model
This model dictates that participants should be compensated for their time and effort in the clinical trial.
Compensation is usually provided at the end of the trial. It is one of the most popular and effective reimbursement models for clinical trial participants.
Under this, participants may receive compensation in the form of thank-you notes, gift cards, or similar gestures.
Conclusion
Compensation for participating in clinical trials is ethically and practically necessary. It not only motivates the participant to follow study instructions to the letter but also helps to find the best-qualified participants for your clinical study.
See Also
What is a Randomized Clinical Trial
Medical Innovation Grants Opportunities
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