Existing Clinical Trial Infrastructure Reveals Alarming Behaviors from Research Subjects
Patients communicated alarming behaviors clearly attributed to a lack of communications and engagement from study teams.
While at the SCOPE Summit in Miami, I had the opportunity to interview several clinical trial subjects, and hear about their fascinating experiences. However, while speaking about their feelings, these patients communicated alarming behaviors that are clearly attributed to a lack of communications and engagement from study teams.
Complicated Consenting Confuses Patients
One of the biggest complaints that resonated with these patients included lengthy and overly complicated consent forms. According to the literature, only 6% of consent forms are written below an 8th grade level; 54% of patients with an 8th grade level understood consents, 72% of patients with an education above an 8th grade level understood the consent; 0% of participants fully understood the details of the consent.[1] One of the patients I interviewed complained that a 27-page consent was too long and complicated, and they reviewed about 25% of the consent form before signing it. This behavior can lead to non-compliance, unethical clinical trial enrollment, and medication non-adherence.
Adverse Event Reporting Non-Compliance
A different challenge that patients and study teams face is adverse event reporting non-compliance. According to the Office of Inspector General, 86% of AEs were not reported from medical institutions; of this sample, 61% resulted from a lack of staff perceiving and reporting the AE, and the remaining 25% resulted from staff knowing of AE occurrence, but, did not report it.[2]
Patients are also not aware of AE reporting. To demonstrate, another patient I interviewed mentioned that they started getting symptoms of shingles after taking investigational product, and they did not report their symptoms to their clinician because they had thought that the event was related to their medical condition. The patient indicated that they would have noticed the signs if they had a toolkit that described potential symptoms associated with the investigational product.
While many of us fear to touch the topic of
In early phase trials, study teams should conduct
Always Remember the Patient
When a patient undergoes a medical ailment (especially severe medical conditions, such as cancer), their entire life changes, and they experience overwhelming feelings and emotions, such as confusion, sadness, anger and fear. It is important for study teams to consider patients’ situations, when designing study visits and materials. While we all realize the importance of accomplishing IND requirements, we oftentimes overcomplicate studies, and patients take the full brunt of our decisions.
Simplifying study visits, and implementing communications tools in clinical trials improve the experience of study sites and patients, which can result in improved enrollment outcomes during the consenting phase, enhanced medication adherence & AE reporting, and minimized subject attrition.
References:
[1] Source: Paasche-Orlow MK, Jacob DM, Hochhauser M, et al. National survey of patients’ Bill of Rights statuses. J Gen Intern Med. 2009;24(4):489-494
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