A study published in the New England Journal of Medicine (NEJM) about cancer patients revealed that many who receive chemotherapy for incurable cancers still believe they can beat the disease. The study focused on patients and their caregivers and on how well they understood that the chemotherapy treatment prescribed for them was not curative. Rather, that it was a medical tactic recommended as a strategy to add months to a patient’s life. The article reported on the key findings of the study which reveal that, in fact, the patients and family members were tolerating difficult treatments and side effects for a chance to live – the fact that it was possibly months more was not part of their consciousness.
BBK Worldwide is comprised of media and communication experts. The products we promote to consumers are our sponsors’ research protocols. Our ads and support materials, as with any promotional tool for any clinical trial, must be reviewed by multiple legal authorities with a keen eye toward guarding against wording or imagery that could be coercive in nature.
I was sitting in my synagogue for the Jewish New Year when the rabbi began his sermon. It was all about his friend who participated in an oncology clinical trial (end-stage cancer) and how he seemed to be responding to the treatment but, subsequently went into failure. He survived long enough to find out that he had been in the placebo arm of the study. (Study reached completion and therefore his doctor was able to provide this information.) “He received the placebo,” the rabbi said emphatically.
The automobile industry spends billions of dollars annually researching consumer preference in cars. Each car, each feature of that car, is thoroughly analyzed and mounds of data are correlated with regard to the likes and dislikes of potential purchasers.
What's more, the discerning consumer has completed hours upon hours of research before he/she ever ends up at the dealership. One size does not fit all.
So what does all this car talk have to do with your protocol? The consumer movement in healthcare is in its mature stage. The enlightened patient is well aware of options, and each nuance of a clinical research protocol can affect the “purchasing decision.”
Each data point within the protocol is a product “feature," one that exists, of course, to manage the science behind the clinical study but, often overlooked or misinterpreted as a variable that can make or break recruitment, enrollment and retention. Your protocol's features dictate promotional messaging and tactics deployed. A thorough analysis of these features with regard to the competitive landscape and the health care consumer's needs and preferences is mandatory for recruitment success.
Consider the following scenarios:
- The clinical team demands that the study identity and patient materials from a previous study be utilized to promote another study of the same medication for the same therapeutic area. However, the first study targeted drug naïve patients and for the second study, not the case.
Even if it’s the same medication, same condition, same sites, this change cannot be overlooked in messaging.
Columbia Presbyterian Medical Center, New York City. Oncology Radiation Division. Six weeks of daily treatments. Monoclonal antibody infusion each Friday for same period. Side effect profile: joint pain, dry mouth, malaise, flu-like symptoms, dry crusty skin, swollen eyes, lymphoadema (may last indefinitely with other potential risks associated with this), depression, risk to healthy tissue. Patient: 90, Holocaust survivor, war hero, husband, father, grandfather, great grandfather. Prognosis: visible tumor shrinkage under arm; most likely inoperable, time will tell and time is the only reason for pursuing the treatment to begin with.
So here at the DIA in Philly, BBK has given away 1,500 t-shirts. One hundred t-shirts per hour to be exact. DIAers are ecstatic with this giveaway. It has everything SWAG (stuff we all get) should have. Pithy sayings about our industry; references to the great city of Philadelphia; color variety -- a great all around giveaway displayed in a cleverly designed booth that defines attention. BBK is the talk of the show, breaking records for Twitter activity and securing numerous Likes on Facebook. Small booth space is no obstacle here.
So, you go to a restaurant and you order steak. What comes to the table doesn’t remotely resemble the savory course you envisioned. In fact, you can’t even tell exactly what sort of carnivore was slain for your dinner. Do you eat it? Not usually? Without a good sense of what you are getting into, you are less likely to take an action.
Having played a significant role in recruiting patients to clinical trials for more years than I care to admit, I've learned a thing or two about how the medical community relates to the option of clinical trials for their patients. Here it goes:
So, in the clinical trial arena, we have established reimbursement scenarios from sponsors to vendors, vendors to doctors, and doctors to patients that are so complex. Often the frustrations everyone has in getting paid end up with patients somehow bearing the brunt and never receiving financial support for their expenses.
Just got out of a five-hour meeting. I was very impressed with this clinical team's desire to create a pilot for data sharing that is truly industry trendsetting. To run a clinical trial means to gather data — infinite amounts of data. I’m talking about multiple systems to house the data with each system having its own login and numerous input points.