The time and expense of clinical trial participation are barriers to enrollment, especially for individuals of lower SES. A policy that allows payment for trial-related expenses could lower these barriers.
Despite misplaced concerns about undue inducement, allowing for reimbursement of these costs on a protocol-specific basis is ethically sound. It would remove what participants often describe as a disincentive to participate.
Cost
The cost of participating in a clinical trial varies. Private insurance and Medicare typically cover routine patient costs, including deductibles and co-pays for medical tests and treatments that are part of the study. The study sponsor pays research costs and may include the investigational drug, extra doctor visits, electrocardiograms or blood draws, and certain lab and imaging tests.
The length of a clinical trial can add to the overall cost because longer studies are needed to confirm that the investigational medication is safe and effective. Increasing the number of participants also increases the study’s statistical power, which improves its ability to detect treatment effects.
Finding participants who meet the criteria for a specific trial is challenging. Many patients with rare diseases have a limited medical history and are more difficult to recruit. Often, trials are not widely advertised or accessible. Many physicians would prefer to discuss them with their patients.
Many patients face sizable out-of-pocket costs but can earn extra money from clinical trials. For example, those who travel to a study site must pay for gas and tolls. The Leukemia & Lymphoma Society has programs to help cover these expenses, such as its Susan Lang Pay-It-Forward Patient Travel Assistance program and its co-pay assistance program for patients with blood cancers in financial need.
Time
The time required for clinical trials varies by study and is determined by how long it takes to find enough volunteers who fit the specific criteria of the research. It may also take time to prepare and administer the drug or other treatment being tested.
Every trial has a protocol that describes what will be done in the study. It outlines the goals and purposes of each part of the trial. For example, some trials will test whether a new drug works in patients with certain diseases, while others compare one treatment against another.
In addition, researchers must ensure that the participants are adequately informed of the risks and benefits of participating in a clinical trial. This process is called “informed consent.” The researchers will explain all the key points of the study to the potential participants and discuss them in their native language. They must also present a document representing the participant’s informed consent.
Many medical professionals believe that patients participating in clinical trials better understand their disease and how to manage it. This knowledge, combined with regular check-ins by the medical staff, can improve a patient’s health outcomes. However, this is a personal decision that shouldn’t be made lightly. The risks and costs often outweigh the benefits of participating in a clinical trial.
Risk
Clinical trials can have serious side effects; participants must be prepared for this. They must also know that the prosecution may fail, and they might not receive the experimental treatment. This risk can discourage many patients from enrolling in a trial.
Recruiting participants requires a large investment of time and money. Failure to recruit can delay trials and detract from the potential benefits of new therapies. Longer trial timelines increase costs and reduce revenues, which can reduce the number of drugs in a development program.
The cost of bringing an investigational drug to market has recently increased. This trend is limiting R&D budgets for drug manufacturers, making it difficult to invest in more life-changing therapies for patients.
A key issue for many trial participants is the lack of post-trial access to investigational medications. This issue significantly impacts adherence rates, especially in patients with HIV, Dr. Millum says.
Although some states, including Washington, require insurance companies to cover routine care expenses for clinical trial participants, not all do so. To help overcome this barrier, the Leukemia & Lymphoma Society offers financial assistance programs for eligible patients. These programs provide monetary compensation to offset costs and assistance with insurance co-pays and premiums. In addition, the society provides transportation vouchers and lodging support for a limited number of qualifying patients.
Benefit
Clinical trials can help doctors improve medical treatments. When researchers test a new device, medication or treatment method, they can compare it to existing options. This can help doctors determine which drugs, devices or treatments are safe and effective for their patients. Medical research also helps doctors avoid errors. Many mistakes that cause patients to become ill or die are due to a lack of knowledge and experience in a new situation, which can be avoided through clinical trial research.
Participating in a clinical trial can also help people feel like they are making a difference in the fight against disease or illness. The more people participating in medical research, the more likely future generations will have access to better medicines and treatments.
In addition, the risk associated with participating in a clinical trial is typically minimal. Some discomfort or inconvenience may be involved, but these risks are typically no greater than what might occur daily. Most importantly, participants are carefully and thoroughly informed of all the risks and benefits before agreeing to participate in a study through informed consent.
However, not everyone can participate in clinical trials. For example, older adults often have barriers that prevent them from being able to participate in medical research, such as lack of transportation or a disability. This can be a significant problem because the medical community relies on medical research to improve treatment options for their patients.
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