We are addressing two barriers in our proposal: the stigma of participating in clinical trials as a last resort instead of a first choice treatment option and overcoming location challenges with potential clinical trial participants. By using a targeted approach, we will be able to get patients seeking treatment at research hospitals to commit to participating in clinical trials. The stigma that clinical trials should be used as a last-ditch effort in treatment exists because the notion is reinforced through media and word-of-mouth. Many have heard stories through family and friends, or through reading articles and watching TV that clinical trials are only for those patients that are down on their luck. Locational barriers exist because some patients simply don’t live close enough to a research hospital to participate in a clinical trial without incurring significant travel costs. We chose to address these barriers because patients have to be interested in participating in a clinical trial in the first place. We can create new websites and mobile apps and the like to streamline enrollment, which is great, but if patients can’t see past the stigma they won’t enroll regardless of how easy it is to do.
Links:
1. This link describes many fears patients hold when they consider clinical trial participation.
http://jnci.oxfordjournals.org/content/92/19/1556.long2. This link describes patient fears as well as patients' desire to hear about clinical trial options directly from their doctor.
http://www.standup2cancer.org/innovations_in_science/view/the_ins_and_outs_of_clinical_trials3. This link describes patient fears as well as guidance on accessing government funds and other options if you live too far away from a clinical trial and would like to participate.
http://www.asbestos.com/blog/2012/03/29/clinical-trials-fact-myth/
Potential obstacles include identifying ideal institutions to implement the campaign in as well as maintaining patient confidentiality. We will work around these roadblocks by doing our due diligence in identifying research hospitals across the country that we feel can successfully implement our campaign. We will maintain patient confidentiality by only having access to data if it is explicitly HIPAA-compliant and allowable under law. Otherwise, we will train our doctors in the hospital and encourage the use of analyzing data to identify great candidates already seeking treatment in the hospital.
We anticipate an initial increase of 2-4% in accrual rates, with higher rates in the years after implementation. We believe we won’t see a massive jump overnight, but rather sustained growth over time. This is because you can’t change ingrained stigma overnight. It takes time. However, with the targeted data approach in hospitals we mentioned earlier coupled with our volunteer and media approach, we believe we can reach the desired doubling of accrual rates in a few years. We will prove this by maintaining our own data. We will maintain data on how many patients are currently in clinical trials at the research hospital before the campaign begins, and measure how many join as the campaign is implemented. We will collect this data every few months. We will also keep data on how many volunteers we have, how many hours volunteers are in the hospital, how many hours we spend training doctors as well as volunteers, etc. This will help us keep track of how the campaign is doing, how we should be spending money and time, etc. We think it will take at least one year to reach a growth of 2-4% in accrual rates, with a doubling of the current accrual rates in 5 years or less.
We anticipate maintaining growth in accrual rates by analyzing our own data, as mentioned above. This will help us allocate resources efficiently. We will also continuously recruit volunteer infrastructure. The ultimate goal is scalability. If we can successfully recruit volunteers and set up a permanent infrastructure for this campaign in one area, we can then launch a campaign in a new research hospital. We can replicate this campaign across the country and hopefully bring it to scale worldwide as well!
We will overcome regulatory hurdles by upholding strict standards for data. We will not access data that by law we cannot view. We will instead act as encouragers, trainers, and partners if we run into areas where we cannot view certain patient data in hospitals.
We believe various aspects of our proposal may have been tried before, but not in one coordinated campaign or in a specifically targeted area. Other proposals similar to ours either focus on only one element (ie- doctors speaking to patients) or are too broadly focused (websites that act as a search engine for clinical trials without specifically targeting certain areas or individuals). By targeting specific areas (research hospitals already hosting clinical trials and treating local patients) and coupling that with coordinated campaign efforts and proven organizing strategies, our proposal is more innovative.
