Wednesday, February 12, 2014

Clinical Trials Subject Enrollment - Important Elements

Enrolling subjects for a clinical study has been a long time hurdles for the companies to test the efficiency of the drug. Not only that in today's environment, there has been a bombardment of numerous media vehicles which have a varied role in subject's (patients) senses, thoughts and emotions.

These obstacles for the enrollment of the trial subject can be achieved by Access, Desire and Respect.






Access:


Access is associated with how easy it is to acquire something, and patients’ attention tends to veer towards the most convenient engagement option. In clinical trial subject engagement, accessing patients is a crucial hurdle that study teams need to overcome in order to reach and recruit patients, hence, determining the most appropriate medium to implement engaging tools is key towards recruitment success.


Moreover, patients exhibit familiarity and associate trust with healthcare professionals and related environments, which attribute towards environmental familiarity and maximizing engagement.  Implementing engaging campaigns at physical locations, such as pharmacies, is one of many ways in which study teams could access and engage patients, however, it is important for study teams to understand patient behavior and geolocation in order to access patients and yield favorable enrollment results.


Desire:
Desire is associated with addressing a need that is felt as lacking. It is a subconscious effect that sometimes is the result of having a need that has been missing for a long time, such as pain relief, energy, and social acceptance.  Scientifically, when the brain is presented with stimuli that address these lacking needs, the brain reacts immediately and positively by releasing dopamine.
While it is important to attract a patient’s attention, it is important for study teams to not only educate patients about the process of clinical trials, but also neither to over-exaggerate the benefits of clinical trials nor make any promises or guarantees. 

For instance in a clinical study site,  where many campaigns with flyers that exhibited images of overly happy people enjoying their lives. Unfortunately, these campaigns were misleading the reality of patients who had high expectations of getting better by participating in a clinical trial, but, were disappointed and chose not to enroll during the consenting process when explained the risks and benefits of the clinical trial; It was observed that patients were disappointed and they felt that their trust was violated. 
Study teams need to practice caution by understanding their target audience and setting realistic expectations by developing appropriate subject recruitment content and training study staff on how to best present potential risks and benefits of clinical trials.

Respect:
Respect is associated with the achievement of shared goals, and the feeling is developed by recognizing and rewarding this achievement. Scientifically, this behavior stems from the psychology of reciprocity and mirroring, as people tend to follow those who set directives, which fosters motivation and belonging.
Subject recruitment does not stop at the patient; it particularly involves interactions at the study site, and if study sites are not involved, subject enrollment initiatives fail. It was observed that there was a significant relationship between medical chart review frequency and high enrollers. This was achieved by conducting surveys and analytical assesments.

Training programs, Regular communications and toolkits to engage study sites aided in better subject enrollments

Clinical trials are highly dynamic in nature, and each clinical trial requires specific expertise and customized campaigns to reach patients and engage study sites.  Simply implementing one solution towards all clinical trials will not result in maximizing engagement and result in subject enrollment campaign failure. 

Reference: 

www.appliedclinicaltrialsonline.com