How Much Do Clinical Trials Pay? 4 Compensation Models

How much do Clinical Trials payHow much do Clinical Trials pay

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 in nature.

Monetary benefits are rewarded in lieu of the time and effort put in by the participants, and to cover the expenses of traveling, loss of daily wages, etc. along with compensation for any injury sustained from the clinical trial. Compensation for a clinical trial may also consist of medical treatment of the research subject facing problems/injuries 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, fewer drop-outs and it also helps to decrease study timelines.

How much do Clinical Trials Pay

How much do Clinical Trials Pay? – Practical Need for Clinical Trial Compensation

Besides, there are several practical aspects, including administrative resources that are needed to process and deliver compensation, collect tax information, such as social security numbers, postal addresses and feedback to ensure that the participant actually 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 one of the major concerns that research scientists as this phenomenon may adversely affect the participant’s financially vulnerable situation.

When to offer Clinical Trial Compensation?

Due to a lack of uniform standards across the industry, trial sponsors need to make these decisions independently. According to 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 where there are potential health benefits for the participants, the trial sponsor needs to compensate the participant 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 refrain from compensating with amounts that can evidently influence the participant 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 extremely essential to get IRB and other ethics approval of the proposed compensation method even before you start the research study or trial.

Modes of Compensation for Clinical Trial Participants

The process to deliver 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 having full knowledge of 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 answer 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 it essential to collect and report tax information, such as social security numbers?
  • 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 algorithm factors and offers the same amount for 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 as per local conditions. In the US, the minimum wage varies between US$ 7.25 to US$ 11 per hour.

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 of work to take part in the clinical trial. Participants are required to 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 the time and effort they invest in the clinical trial. This compensation is usually provided at the end of the trial. This is one of the most popular and effective reimbursement models for participants in clinical trials. Under this, participants may be compensated with thank-you notes, gift cards or similar meaningful 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 too.

See Also

What is a Randomized Clinical Trial

Medical Innovation Grants Opportunities

Reference links:-

https://www.iscr.org/wp-content/uploads/2019/04/CDSCO_Notice__COMPENSATION_FORMULAE_20-Dec-14._30.pdf

https://www.slideshare.net/BhaumikBavishi/compensation-in-clinical-trial

https://toolbox.eupati.eu/resources/compensation-in-clinical-trials/

https://igmpiindia.org/compensation-models-in-clinical-research-and-issues-concerning-india.html

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