Clinical trials are expensive and lengthy initiatives for testing organizations that often cost millions of dollars and years of effort to research, develop, fund, staff and to recruit and retain participants.
Nearly $2 billion is spent annually on patient recruitment for pharmaceutical trials alone. A lot of the money, time, and energy poured into a trial ultimately hinges on the ability of the participants to complete the requirements that will allow the researchers to analyze the trial results in a meaningful way.
Clinical trials that lose participants before they have completed all of the required assessments are likely to go over budget, end prematurely, or have less-than- meaningful data, sometimes leading to the abandonment of potentially effective treatments. Increasing the percentage of participants who fully complete a trial can save time and money and increase the quality of clinical trial data, all of which are critical to identifying effective treatments.
Why don’t people complete their clinical trial?
There are two main reasons participants don’t complete a clinical trial. The first is called early withdrawal, when a participant decides they no longer want to participate and they withdraw their consent. Participant discontinuation is the second major reason. This is when the investigator or sponsor decides to end the participant’s continuation in the trial either because they have not complied with the requirements of the trial, jeopardizing their own safety and the trial data, or because, for other reasons, the investigator or sponsor feels it is no longer safe or in the participant’s best interest to continue in the trial.
Of course, there are reasons for withdrawing consent that are beyond the participant’s control: death, illness, job change or relocation, family obligations, financial hardship, or legal problems are some potential factors that could end trial participation. Clinical trials can last for years and a lot can happen in the lives of participants. What seemed exciting and doable when someone first enrolled may become unmanageable because their life changed in ways they couldn’t have predicted.
For others, though, withdrawing consent or simply stopping their participation is due to reasons that are, at least in part, modifiable, such as: diminished interest in the mission of the trial, disagreement with the clinical staff, or feeling burdened by the demands of the trial’s schedule, documentation, reporting, diet, activity, or travel. These types of reasons are the focus of researchers and research organizations working to design trials that are centered around the participant as much as they are around collecting data.
What can be done to increase trial completion?
Much of the onus to minimize participants’ early withdrawal is on researchers to design more participant-centric trials. However, there are things participants can do to increase their chances of successful trial completion.
The informed consent process is your time not only to ask for a clear understanding of what will be expected of you, it’s also the time for you to be honest — both with the investigator or study staff about what aspects of your life could change over the duration of the trial, and with yourself, about how motivated or able you will be to seeing the trial through to the finish line.
It’s also helpful to share your concerns about which aspects of the trial seem like they may be difficult for you. The clinical trial team may be able to work with you to make these aspects less burdensome. If acceptable accommodations cannot be made or you still have doubts, remember that participation is always completely voluntary, and if you decide participating in a clinical trial is not for you, that is always okay. Your careful consideration will be greatly appreciated, and regardless of your choice, you will have contributed to the success of the clinical trial.
This blog is intended to be informational in nature. The information and other content provided in this blog, or in any linked materials, are not intended and should not be construed as medical advice, nor is the information a substitute for professional medical expertise or treatment.
If you have any questions or concerns, please talk to your doctor. Never disregard professional medical advice or delay in seeking it because of something you have read on this blog or in any linked materials. If you think you may have a medical emergency, call your doctor or emergency services immediately.