Over the years, I have participated in multiple clinical trials differing in patient participation levels with researchers, outcomes reported to me as the patient, and follow-up support. I also have been suggesting clinical trials to others as well with the caveat to “check for yourself,” because not all trials are run in an effective, transparent style. I have seen this as trial creators are using more patients in their clinical trial setup process — not just as patients participating in the trial, but from conception of the trial through the final phase 4 and bringing the drug to market. Doing this has helped patients have more trust. As patients in a clinical trial, we are in a vulnerable state; knowing that there is transparency, trust, and accurate information can make a great difference.
Clinical trials are the most visible part of biomedical research. The website tends to be our first impression of the trial sponsor. So, if a website is not transparent or sends the wrong message the patient may conclude before even getting involved that the trial is also not being conducted with integrity and transparency. It gives people pause as to whether they should be involved in the trial, try the treatment after trial data is released, or even respect the results, if reported. The more we are all participating in each aspect of the trial, the better trust and openness in the clinical trial efforts.
We must help shape the patient experience. The ease of finding a clinical trial and the more detailed the trial information, the better brand perception the sponsor will achieve. When the trial sponsor has a dedicated trial website enabling patients and caregivers to read the fine print, ask questions, and be educated, more patients want to participate in the trial. Such a website also connects sponsors with investigators, impresses potential product investors and helps further medical research. These are all especially important when developing a trial for rare diseases.
There are great benefits to clinical trials for the whole human race as well as individual groups of people with the same disease. Yet, there are also downfalls. One of the biggest challenges I have seen when looking at clinical trials is access. I know patients who have been kicked out of trials because their data was skewing the trial data, preventing the outcomes the trial sponsors were hoping for. I have also seen very narrow trials. For instance, only taking patients with a particular disease who have had it for less than two years with limited physical effects. This past September I was at a conference highlighting gene editing and therapies, and one research doctor commented: “It’s hard to be one of the first people to step up and say, ‘Yes use me. I want to be the one who gets this trial even though we don’t know exactly what will happen.’”
We need to be able to trust the researchers and to know they will uphold the highest standards of the scientific rigor and ethical oversight. Clinical trials have evolved and improved over time. I believe that the improvements have come from patients having a voice in the process. Instead of lab rats, we are partners in the studies. As the clinical trials involve more patients in the entire process, we are also seeing better and faster diagnosis, treatments and prevention. Although there are still major challenges and not all researchers are conducting clinical trials ethically, knowing what to look for to determine if the trial is right for you, is now something that you as a patient in need can decide for yourself.
When I am trying to decide if I will participate in a trial, I look for key inclusion points:
- Were any patients involved in creating this trial? I have participated in trials both ways and, luckily for me, it all turned out OK, even if it didn’t result in a viable treatment option for me. I know others who writhed in agony during a clinical trial and others who became suicidal.
- If applicable, has the sponsor shown a commitment to publishing past trial results, irrespective of findings? Far too many of my friends have had their data excluded or they were removed from the trial because their results were contradictory for the medication or medical equipment being complimentary to their care. If I am going through a trial, I want to know that my data was included in the results no matter the outcome. I have qualified for the study and if I am unable to complete it, that should also be notated. When I look at past studies, I also want to know that the raw, anonymized data is available upon request to other scientific research teams so that the trials can be repeated for accuracy or working toward another variation. When the trial sponsor is transparent in the process — from paperwork to instructions, data analysis, and presenting the results in past trials — it should be a good indicator that the current trial will also be transparent.
- How long is the trial? I also like long-term trials. I know when I am going through new treatments, sometimes it takes a few weeks to months to really know if something was helpful or harmful. I want to know that if I put this implant device into my body that it has been studied in the trials at least two years after implant.
- How are previous participants doing? At the very least, the trial sponsor or principal investigator/researcher should follow up on the participants.
Back in 2012, I participated in a trial that now has the results included in multiple medical journals and books. Yet, the trial principals still contact me and maintain the device. The medical device was a positive in my life and changed my future treatment plan. I wanted to continue and was able to with the help of the study researchers. Although the trial ended in 2015, I am still using the device and continue to receive maintenance and follow-up care, which is also documented. That is the type of transparency I would like to see from other trial sponsors.
The National Institutes of Health (NIH) has created Good Clinical Practice (GCP) Training sessions for researchers and trial sponsors. The GCP guidelines are specifically created to assess the merits and feasibility of the trial process. As a patient, knowing and understanding the trial I am about to participate in is important: how will it be run, will there be placebo subjects, will there be long-term follow-up, will the data be transparent? All of this should matter to the patients who are signing up to be the first of the first.
A dedicated clinical trials website that automatically pulls in study results and updates is an ideal way to engage patients and caregivers before trial participation. Center for Information and Study on Clinical Research Participation (CISCRP) stats show that patients are far too often kept in the dark. We must keep trial participants informed on better health and treatment options worldwide while improving trial research for all involved with a new level of transparency and accountability.
Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website.
The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of International Pain Foundation or other companies she refers to in this article.
