Existing Clinical Trial Infrastructure Reveals Alarming Behaviors from Research Subjects


Applied Clinical Trials

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.

Simplifying consent form content, leveraging digital consenting technologies, and incorporating visualizations and humanization media (i.e., videos) can not only ensure consenting compliance, but, also improve ethics, consistency in consenting communications, and medication 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 AE reporting, it is essential and ethical to encourage AE reporting during clinical trials, as not reporting AEs could result in the FDA approving a medical product, only for them to prematurely take the product off of the shelves (though rare), and enforce black box warnings after approval, which impacts sales and R&D investments. For example, the FDA withdrew Vioxx from the market in 2004 (after being approved in 1999) because post-marketing data demonstrated increased risks for cardiovascular problems. [3]

In early phase trials, study teams should conduct statistical analyses on AE data (from real-time EDC data, EMR data, and AERS data) to identify potential AEs and implement communications tools to educate study sites, patients and their families about the importance and process of AE reporting.  In later phase trials, study teams can evaluate empirical AE data from early phase trials and implement communications campaigns, accordingly. Study teams can also identify potentially unreported adverse events through analytical risk-based and centralized monitoring techniques. With engaging communications tools, patients and study sites can not only expect AE signs, but also activate AE reporting systems.

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.



[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

[2] http://oig.hhs.gov/oei/reports/oei-06-09-00091.asp?goback=%2Egmr_4418518%2Egde_4418518_member_140184035

[3] http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm106290.htm

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