The randomized controlled trial (RCT) is commonly referred to as the gold standard in clinical research. From Wikipedia:
The key distinguishing feature of the usual RCT is that study subjects, after assessment of eligibility and recruitment, but before the intervention to be studied begins, are randomly allocated to receive one or other of the alternative treatments under study.
Still, there are various ways a clinical trial can be designed to both achieve the objectives of the patients and researchers and to test that a new treatment is safe and efficacious. As you scroll through trials on ClinicalTrials.gov, you may notice references to Adaptive study designs, Balanced and Unbalanced study design, Bio-Availability and Bio-Equivalence studies, and many more. Understanding more about the terminology and methods used in a clinical trial might help patients to more easily determine whether a clinical trial is right for them.
We’ve chosen to focus on crossover studies for our latest infographic. Crossover studies can be of special interest to some patients, because they typically ensure that every participant will receive the study drug at some point during the trial.
Photo by IntelFreePress
When we talk to patients about the challenges they face while participating in clinical trials, they tell us that it can be difficult to integrate the study’s requirements into their everyday lives. Providing the amounts and types of data that researchers need for a study can be a cumbersome and time-consuming process, especially when it requires manually filling out journal or log book with details about side effects, vital signs, diet, exercise, treatment efficacy and more.
Significant solutions to these problems will likely come from re-thinking clinical trial design with patients’ needs in mind. But, short-range wireless data transmission technologies—like Near Field Communication (NFC) and Bluetooth—can help us to take steps in the right direction.
The healthcare industry is seeing growth in the number of health devices that offer wireless and mobile connectivity. One application of these devices focuses on transferring data about patients to a doctor or health care provider in an effort to manage disease. Additional potential exists for wireless and mobile devices to be used to make clinical trial participation more efficient, and thereby more convenient, for patients.
Part of Lilly COI’s purpose is to continually explore ways to improve the clinical trial experience through technology. So far, we’ve built an API and clinical trial search tools from data available on ClinicalTrials.gov, co-hosted a codeathon, and sponsored challenges to help encourage the development of creative and more patient-friendly clinical trial resources.
And, we know we’ve only scratched the surface of possibilities. We’re excited to see wearable sensors, near field communication and 3D printing coming to the forefront of medicine, and are brainstorming and exploring what our next projects might be.
So that we’ll be ready to explore any inspiration whenever it strikes, we’ve been building up our arsenal of technological tools and resources. This week, our Makerbot 3D printer arrived:
In December, we published our first infographic. Our goal was to start a discussion around the question: “How often do patients receive placebos in cancer clinical trials?” After digging into the data from cancer trials registered on ClinicalTrials.gov, we found less than a 1 percent chance of a patient receiving a placebo alone on a cancer study. The majority of placebo-based trials adminster the placebo along with standard of care treatments.
We received some great constructive feedback on the graphic from the patient advocacy and clinical research communities through our blog and Twitter. We appreciate those who asked clarifying questions and gave us suggestions for future infographics. Armed with their input, we went to work on our second infographic.