The following blog post is by Lane Rasberry.
Lane has participated in more than 40 clinical trials as a healthy volunteer, as well as worked on the research team conducting clinical trials for the University of Washington. He's a fan of clinical research, and has served on community advisory boards for clinical trials. He's regular Wikipedia contributer and member of WikiProject Open Access as well as WikiProject Medicine. Lane works with various patient and research participant rights groups as well as the Open Knowledge Foundation to promote and advance science in the Seattle area. As such, Lane brings a unique, multi-dimensional perspective on clinical trials.
I became interested in clinical trials when I moved to Seattle from rural Texas at the age of 20. I had no job skills, and no experience or real interest in clinical research.
One day I saw an ad offering the equivalent of minimum wage for my time as a participant in a clinical trial, and I took the opportunity. Soon after, I started studying chemistry in college and joined more trials. I participated in about 40 of them over a period of years.
After I graduated from the university, I took a job conducting clinical trials for one of the school’s health departments and joined a community advisory board for an organization’s clinical trials.
Through my experiences, I became a supporter of clinical research; and, I encourage other people to participate in clinical trials. I also encourage researchers to appreciate and support their trial participants.
Better Access to Information
As a research participant, what I found myself wanting most often was better information about the trial. Before starting the enrollment process, I wanted to learn more about the study, but my options for that were limited.
In my opinion, clinical trial protocols and informed consent documents should be published online, in layman’s terms, for anyone to access at any time. I am aware that sharing information outside of the supervision of the clinical staff invites the risk of misunderstanding, but as a participant, I feel that I have a right to access the routinely presented information about trials with little hassle.
ClinicalTrials.gov Not Enough
One of the only options a potential subject has for learning about a trial is the government website clinicaltrials.gov. I find this site alone to be insufficient in communicating with participants, because the information is not geared toward laymen, and because the information listed for each trial is often not complete.
I would like for researchers to define a minimum amount of information that all participants in all clinical trials will get, and for that minimum to be consistent across all organizations. Often, upon joining a trial, the researcher will give additional information to the participant that was not included in the study's informed consent document. Why not just make sure that all of the information is available from the start?
Sharing the Results
Another thing that I want from researchers, is a follow-up when the results of a study are published. Some researchers call this the right to “return of results.” Getting this right has been a decades-long headache due to research participant confidentiality and privacy concerns.
In all the trials in which I have ever participated, there has never been a plan in place for sharing research results with me. When I did obtain the results it was because I made the effort to request it, often years later.
I have no idea how to address this problem for everyone. But, personally, I would like to be able to request a follow-up through email. The way I see it, if my email is secure enough for every other aspect of my life, then it is also secure enough for clinical trial data. My email account includes links to all my finances along with every scandalous conversation I have ever had. I would not have any personal privacy concerns in regards to receiving results and data via email.
Sometimes, researchers may assume that participants wouldn't be able to understand the report on the results from the study anyway. I may be unusual, but even if I cannot fully understand the results from the study in which I participated, I still want to have the option of viewing them; and, I do not want to pay for access.
Make Sure Participants Have the Best Possible Information about your Trial
My participation in any clinical trials is ongoing. Even when I am outside the clinic and away from the researchers. I talk to my friends about the trial before the trial, during the trial, and after the trial. I wish that more researchers recognized how much conversation about their trials happens outside of their view. It would greatly benefit them if participants were given the best possible information about their studies, to help ensure that misunderstanding and misconceptions don't discourage willing subjects from participating in their trials and in future clinical research.
At Lilly COI, we agree that patients need better, more relevant information about clinical research. We have multiple efforts underway to help with this issue, including our recently launched Clinical Trial Visualization Redesign Challenge. Stay tuned for more announcements about our efforts to improve the clinical trial experience for all.