people dropping out of clinical trials: 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). To avoid having people drop out or withdraw from clinical trials and to improve retention of participants throughout the full study, it will require an innovative trial procedure for a favorable outcome.

Reasons for People Dropping Out of Clinical Trials

1. 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.

2. Lack of condition improvement

   - If a patient joined a trial program to get treatment for a current ailment, then most likely they will withdraw before the trial ends if there is no improvement.
   
   

3. Personal or family reasons

   They include divorce, marriage, the death of a loved one, relocation, loss of transport, and changes in job status.
   
   

4. 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.
   
   

5. Missed visits

   These can be as a result of forgetting or no follow-ups. The research team has the responsibility of contacting the study participants before and after a missed visit.
   
   

Other Reasons People Give for Dropping Out of a Clinical Trials:

• 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 or a controlled environment (i.e., in a lab or clinic) to get their blood drawn by a phlebotomist, which can be an inconvenience.

Many people find venous blood extraction with via a needle in the vein to be unsettling; this can cause stress or anxiety and eventually lead to dropouts.

However, dried blood microsampling with portable microsampling devices requires only a few drops (10µl) of blood drawn from a simple finger stick. Additionally, finger-stick microsampling doesn't require a trained phlebotomist to perform the sample collection.

It can be a self-administered sampling procedure that doesn’t need to happen in a controlled environment. With remote finger-stick sampling, people can perform the sample collection in any location and mail their samples to the research center labs for analysis.

Other Solutions for Retaining Clinical Trial Participants

• 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 dropout or withdrawal determines the success of a study. Uncomfortable procedures, inconvenience and a lack of proper communication can become burdensome and will frustrate your trial participants. The use of remote microsampling that can occur at home, work or any location will open doors to virtual clinical trials and help improve retention levels.

Have you seen our resource page on Decentralized Clinical Trials (DCTs)?

Image credits: Shutterstock, Trajan Scientific and Medical, Neoteryx