why do patients withdraw from clinical trials? (and what can you do about it?)
Clinical trials are the procedures for measuring the safety and effectiveness of health interventions. They are commonly known as randomized controlled trials (RCT). Successful retention of patients to a full study term is the favorable outcome.
Reasons for Patients' Withdrawal
Side effects - If the medication causes side effects like weight gain then a patient who struggles with obesity will withdraw before the trial period ends.
Lack of condition improvement - If a patient joined a trial program to get treatment from current ailment then most likely they will withdraw before the trial ends if there is no improvement.
Personal or family reasons - They include divorce, marriage, the death of a loved one, relocation, and changes in job status.
Noncompliance - The study’s exhaustion can wear out the subjects resolve. This is as a result of a lengthy study, research medication, blood sampling, and follow-up visits.
Missed visits - These can be as a result of forgetting or no follow-ups. The research team has the responsibility of contacting the patients before and after a missed visit.
- Misunderstood expectations
- Lack of condition improvement
- Fear and anxiety
- Lack of appreciation
- Financial constraints
- Inconvenient location
- Schedule conflict
- Change of residence
- Fear of the trial procedures (blood testing, medication, etc.)
Microsampling Improves Clinical Trial Subject Retention
Blood testing is a key component in clinical trials. Traditional venipuncture sampling demands patients travel to a specific location within a controlled environment, thus inconveniencing a lot of subjects. Many patients find venous blood extraction to be unsettling; this can worsen the fear and eventually leads to dropouts. However, dried blood microsampling requires a single droplet (10µl) of blood drawn from a simple finger prick. Microsampling is a self-administering sampling procedure that doesn’t need a controlled environment. Patients can take the sampling from any location and mail it to the research centers.
- Compensation and recognition
- Commitment to the study
- Positive response to treatment
- Relationship with study staff
- Set expectations upfront during discussion
- Send reminders for upcoming visits
- Providing a patient friendly environment
Clinical trial subject withdrawal determines the success of a study. Lack of proper communication will frustrate your patients. The use of microsampling among other solutions will improve retention levels.
Topics: Clinical Trials