Patient Centered Clinical Trials

The term “Patient Centered Clinical Trials” is the latest buzzword in the medical field. It seems silly that creating trials while collaborating with patients hasn’t been the norm in the past. If you really think about it, why does anyone go into medicine? To help patients. But it seems that researchers and pharma companies have focused on the science without asking patients what they really need.

In October, I attended a conference for Patient Centered Clinical Trials, which was presented by a company called eye for pharma. I had the privilege of being on the patient panel. After each presentation, the panel was asked for feedback. That alone is a step in the right direction.

I have never participated in a clinical trial, but not for lack of trying. I am often excluded due to medications or treatments that I am on. Going off of certain medications in order to participate would only increase my pain level which I’m not willing to do. However, through working for Migraine.com, I have a unique perspective on this issue because I spend a lot of time listening to patients’ wants and needs.

Presenters ranged from pharmaceutical companies to Google Health to Patients Like Me. Our own Olivier Chateau, co-founder of Health Union (Migraine.com’s parent company) even presented on how online patient communities are an untapped resource for willing participants. The topics were not Migraine specific. Actually multiple diseases were discussed. Although I’m not an expert or have an M.D. after my name, I knew that I wanted to be part of the conversation and to represent patients wanting to participate in clinical trials.

Some presenters were ahead of the curve, while others are only beginning to think about patient input. I learned so much from being involved in the conference. It was a two-day brainstorming session for everyone in attendance. It was clear that those involved recognized that the number one purpose of clinical trials is to improve patient lives.

I wanted to share with you highlights, trends, ideas and thoughts I walked away with from being a part of this conference.

• Personal Connection: There is a significant disconnect between pharmaceutical companies and the patient. From the scientists in research & development to the sales representatives, all stakeholders need to have a personal connection with the disorder or disease they are working on. Sharing patient’s personal stories, whether via email or in person, with everyone from the CEO to the sales reps would hopefully re-focus their involvement in the process. Only then will pharma truly be patient-oriented.
• Caregivers: After multiple presentations, it became obvious that not only was the patient’s voice often overlooked during the clinical trial process, but the caregiver’s voice is even more absent. Those dealing with patients on a daily basis can have insights into a disease that others never think about. Caregivers have a different perspective that is just as valuable.
• Demographics: Trials generally include white, middle aged men and women. Minorities are seriously under-represented. I believe diversity in a study should be discussed or even required. Won’t that lead to more accurate results? There are often roadblocks to recruiting minorities. I was impressed with the company, Clincierge, who works with potential trial patients to manage these roadblocks. They handle logistics such as arranging and paying for transportation and lodging. This business model is truly patient-centered.
• Study Results: Patients who participate in a study should ALWAYS get the final results of the study. I was shocked to learn that isn’t the standard. As a participant, I would like to see the analytics of the study that shows how my data compared with the rest of the group.
• Patient Involvement in Design: Only 15% of clinical trials consult with patients prior to developing trial protocol. This doesn’t make any sense. The patient voice needs to be heard from the beginning. This could save a lot of time, money and energy in the long run. Researchers may begin the process with unreasonable expectations, not realizing that a part of the trial is unrealistic for patients to complete. They need to fully understand the daily issues patients face due to their condition. Including patients in creating trials will only yield better results.
• Research vs Care: “Research does NOT equal care,” said presenter Stephen Rosenfeld. Patients need to be educated when signing up for a trial. Their expectations need to be managed. Participation in a trial should not be perceived as a last resort for treatment. This begs the question of what role does the patient’s primary care physician or specialist have in this process?
• Finding Trials: Patients who want to participate in clinical trials find it difficult and frustrating to match with a program. Doctors rarely mention the option of being in a clinical trial during regular visits. Those who choose to seek out a trial on their own often lack direction. They may spend time engaging with a trial for which they won’t qualify due to certain restrictions placed in the trial guidelines. The current NIH search engine for open clinical trials is very confusing. I was impressed with Trial Reach’s approach of manually curating trials in their database to more adequately match patients and trials.
• Medical Devices: From contacts that can calculate glucose levels in diabetes patients to using a watch that captures information during seizures and sends info to your doctor to designing a spoon that measures the tremors of Parkinson’s patients, there are amazing advances in technology that are helping patients to provide accurate data to their doctors. Gathering data using smart phones or watches allows the doctor to see the results in real-time.
• New Frontiers: As a chronically ill patient, I was curious to hear about technical advances in this area. I was disappointed to learn that most medical device companies and even research companies are focused on “epidemics” or issues that will provide immediate relief or even a cure for patients. While I am glad that serious and often deadly medical issues are top priority, it leaves me feeling uncertain about new advances in the chronic illness space.

At the end of the conference, I shared a quote from my 80-year-old grandmother. She was part of a heart trial at NIH almost 30 years ago. She was impressed that she could look at her records and felt appreciated for her involvement in the study. She said, “I did it for future generations of my family, not just for me.” Let this serve as a reminder of the importance of clinical trials. And let’s not forget that the patient’s insight during the entire process is just as crucial as the scientists and clinicians who develop new drugs or treatments.