June 23, 2022
The Time the Tables Turned and I Was the Patient
⚠️ Spoiler alert: I did not like wearing the patient “hat”
Industry Expert & Site AdvocateGuest
For more than two decades I have worked in the clinical trials industry, and I love what I do. The journey has been a long and winding road, but I found a new opportunity at every turn.
My career started with my role as a study coordinator at a clinical research site, where I learned the ropes to manage clinical trials. Then, I moved to the sponsor side, which was the beginning of my clinical operations career. From there, I moved into the contract research organization (CRO) space where I continued with different roles, including line management. But as I continued my path, I found another new challenge involving country and regional strategy so that I could provide pharma companies with a clear landscape of my region, guiding them with the opportunities and challenges to help them to make informed decisions.
Pragmatism meant I had to develop strong business acumen and promote clinical research from different perspectives. I learned a lot. But after some years, I missed working closer to clinical research sites and I knew it was time to go back to my roots. The last decade I have been developing meaningful relationships and partnerships with sites, facilitating the connection between sites and the right trials, helping them to develop their capabilities. I did that at a CRO until the most recent turn, which led me to a certain technology company – yes, you guessed it! Now at Teckro, I bring the viewpoint of sites to the table ensuring that our products provide them with the best tools and support they need and deserve to manage their daily workload.
My Patient Story
I started this blog with my career experience so that you have context for my story on the other side of research. I have loved, and still do love every hat I have worn in my career. But then I became the patient. I did not enjoy wearing this hat…
I have a medical condition and there is no medication to treat it. It is not life-threatening – after all, there are many unmet medical needs beyond cancer. I discussed options with my treating physician and there were a few, so I asked about the clinical trial option. She mentioned a phase I trial but was unsure about the status especially due to COVID-19 challenges. At that moment I realized that it was time to take ownership of my medical care.
I am not embarrassed to admit that I tried some alternative medicine options, but none of them worked. I did not give up, so before trying another type of life-changing treatment I decided to give a clinical trial a shot. I was not sure about the status of the few clinical trials that were out there, but this time I did more in-depth research of the clinical trial landscape. I did what I do at work: I went to ClinicalTrials.gov and checked out my options thoroughly.
The Phase II Clinical Trial
I found only one Phase II trial. I looked at the site locations to see if any of them were in my area – the closest was three hours away. Nevertheless, I did not consider that a limitation as I was willing to drive there. When I tried to find the name of the sites, the information was not included. The contact in all cases was a recruitment company – so I sent them a message. The following day, they answered and provided a link with a very brief description of the trial and a survey with some questions I answered. This page also included information about the site’s locations and to my surprise they were opening a site which was only 40 minutes away. “This is a good omen,” I thought.
The initial information I provided took me to the next step which was a deeper review of my medical records. The very same day I signed the Health Insurance Portability and Accountability Act (HIPAA) documentation to release my medical charts. To be proactive, I also contacted my providers to inform them of my decision to participate in a clinical trial and asked them to please provide the documentation promptly. Everybody was very supportive.
That was in early February…
I waited weeks. When I did not get any update, I decided to contact the recruitment company. After a few more days, they responded and informed me that the specialists needed a procedure report at least six months old. They had one that was two months old, but they had to request an older one. Fortunately, I had a legible copy of the first procedure that was 11 months old, which I offered to provide. Nobody answered. I sent a second message. Radio silence. After the third message, I finally got a reply that included an apology for the delay and instructions to send a copy of the report to a specific email address, which I did on the same day.
By this time, it was mid-March.
I waited a few weeks and then sent another message to request a status update of my case. I did not get a reply. I tried a few more times with similar results. Finally, when I did receive a response, they sent me the exact same message I received when I initially started the process a month earlier. It was like nobody checked all the documentation I had already provided. I was being treated as if I were a completely different patient! They were starting the screening process all over again!
That was in mid-April.
I felt ignored, upset, frustrated, and disappointed, all at once. I gave myself a few days to calm down and decided to call the central phone number that I found at clinicaltrials.gov at the beginning of the process. Previously all my communications had been in writing, as we do in clinical research, but I thought that I would be able to get some additional information over the phone about my status. I was trying to find out if my chart was still under review, if I did not meet the criteria, or if the enrollment was closed. The fact that I got an answering machine was not a surprise based on my experience with them.
Patients deserve respect, empathy, and gratitude. This was not patient centricity.
The Frustrating Conclusion
I am not a person who gives up easily. I still wanted to know what happened to my file and what my status was. I decided to try the last thing, and I went to the company website looking for another phone number. There I discovered that they had a chat feature and luckily it was a human responding to my queries, not a bot! But unfortunately, I had to explain the whole story again to the person on the other side of the chat.
It took a long time for the person to find my file, even though I provided my case number. And then, after all of that time waiting on the chat, I was informed that I did not qualify for the study! I was furious – but also ashamed of that recruitment company. If they cannot manage recruitment processes for patients efficiently, they should not be able to work in clinical trials. Patients deserve respect, empathy, and gratitude. This was not patient centricity.
Why I’m Sharing this Story
As I started this blog, you can see I have decades of experience. I know how things should work with clinical trials. I was appalled by the way I was treated and the time I wasted. And while my condition isn’t life threatening, I did have hope that perhaps this clinical trial could work for me. I can’t imagine if I were a different patient with a different condition… It’s heartbreaking to think about.
I am a person of action. And I’m fortunate to have a platform to reach people in the industry who can fix this so others don’t have my experience. That’s why I am sharing my story. And I would like to offer words of advice:
- If you are a biopharma company, please be careful when you pick your vendors. You want to enroll the right patients on time and get good data quality. Please do not allow the pressure to cloud your judgement.
- If you are a site and think that a sponsor is making a mistake with centralized patient recruitment services companies for your clinical trials, please speak up. Do it for your patients. Advocate for your own methods if they work and are more beneficial for patients.
- If you are a patient recruitment vendor, remember that patients are human beings who deserve respect and compassion. Implement the right processes to ensure that the best service is provided to each of them.
- If you are a patient who is trying to get on a clinical trial and you are facing challenges, please don’t give up. In my case, I didn’t qualify. But that may not be the case for you. Clinical trials can offer an alternative to best standard of care. So, it is always worth trying. There are a lot of people in the clinical research community who, like me, work hard every day to improve the process – people who care. Believe me when I say that I understand you. Because I am you.
Industry Expert & Site AdvocateGuest
Silvina has worked the industry for over 20 years and draws expertise from the Health, Pharma, CRO and Tech sectors. She thrives in cross-functional teams developing site-patient corporate goals and objectives. With the skills needed in establishing partnerships and alliances, Silvina is able to visualize impacts of new technologies for every clinical trial stakeholder.