Wednesday, September 17, 2014

Clinical Trial participants are people too

Patients who participate in clinical trials want things to change.  Should Patients have any control over the clinical trial process? Traditionally, clinical trials are run according to the protocol designed by the pharma company, driven by statistics required to prove a drug is safe and effective. The visits are designed to collect the required data.  Sites are recruited, then sites find the patients.  Patients come in for their visits, if they are eligible for the trial, they enroll, receive their meds and come back for visits as dictated by the protocol.  When the study is over, they will typically be told what treatment they have received, and may receive some follow-up care.

Patients want all this to change.  Patients want to talk and communicate with other patients, and they want to have a direct impact on the clinical trial process.  It makes sense that patients would like to see some flexibility in their visit schedule, or want to have less blood draws.  However, according to speakers at a recent patient-centric conference, patients want these things, but they also want to help determine quality of life (QOL) and safety and efficacy indicators for their individual condition, and they really want access to their data.

One of the patient advocates worked with a pharma company that had a study recruiting patients with ‘Mental Illnesses’.  The advocates explained using ‘Mental Illness’ to describe their condition wouldn’t attract many people. They changed the title to be a study for ‘Emotional Wellness’ and were able to better recruit patients for their clinical trial.  According to this advocate, patients want to clinical trials to look sexier and more appealing.

Some pharma companies such as Janssen are introducing patient portals where a patient can login, see their visit schedules, descriptions of upcoming procedures and visits and better understand what will be happening during the trial.  Patients can see a google map showing site location and sign up for visit reminders via text or email.

Sites also want to be more involved with the process. Typically sponsors give the sites they use a rating or quality score based on how the site have performed in the past.  Sites want to know what their scores are and they want to use this data to improve.  Sites want to know how they performed related to other sites.

Some pharma companies have concerns over patients using technology to communicate their clinical trial experience.  They are concerned that patients may report adverse events via social media before they get reported to the FDA.  One patient, Jeri Burtchell decided to blog about her clinical trial experience and potentially unblinded the entire trial.  Jeri has MS.  She participated in the trail and she felt strongly that she knew she was randomized to the investigational product and not the comparator.  She wrote about her experiences as they were happening in her Blog, not realizing the implications of potentially unbinding a study.
Read about it here:

Some recent developments that are changing the clinical trial landscape today:
• In 2013, Pfizer launched the Blue Button Project which enabled patients who participated in clinical trials the opportunity to download their individual clinical trial data.  This data can be used to improve their overall health and wellness and can be shared with their healthcare providers.
• Walgreens is offering services to keep patients in clinical trials. They are offering to gather vital signs, weight, etc. in place of the patient visiting the clinic for these checks.
• Pharma are now developing home based trials, some that involve collecting data via a wearable device or smart phone.

I’m not convinced patients need to be involved in the protocol planning process since in my opinion, it is really a numbers game to make sure we can statistically show safety and efficacy.  But I do see some areas of concern and potential improvement regarding the use of technology.
What are your thoughts?

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