My body for science!

Funny I should have seen this article on participating in clinical trials pop up on my Google News page today, as I recently had an OB appointment and some follow ups on studies in which I am a patient. Working in a major medical campus, I’ve seen a ton of advertisements up looking for clinical trial patients, or seeking patients for research purposes. Being a graduate student in the medical sciences, I have also been privy to plenty of the behind-the-scenes minutiae concerning human research (despite the entirety of my thesis work being on mouse cells). As a result, I have a deep appreciation for how HARD it is to recruit patients for research/clinical studies, and how much effort the researchers/clinicians/etc put into making each and every person/drop of blood count.

This makes me a prime candidate for participating in trials/research. Before I had J, I participated in one safety/efficacy trial for an anti-inflammatory to treat eczema. I think I must have participated in at least 1 or 2 research studies while pregnant with J. Post-partum, I was in a breast-feeding attitudes study. And this pregnancy, I wound up signing up for FIVE separate research studies! One on how pregnant ladies respond to the flu vaccine, one on CMV risk assessment, one on effect of probiotics on strep-B, one on methods for coping with post-partum depression, and one massive study on how anti-bacterial soaps affect mother and infant microbiome. (I think that’s all of them….)

A lot of these research studies do have a small amount of compensation for your time and effort (for instance, I received $20 worth of Target gift cards for a blood draw recently). But really, I’d participate even without these small incentives. I believe that human research is an absolute necessity for science/medicine to move forward, so I intend to put my money where my mouth is. Or my body, as it were.

Then there is the situation, as touched on in the aforementioned article, where clinical trials could be a way to get access to groundbreaking treatments years ahead of time. FDA drug approval is a long and arduous process, requiring many clinical trials (further reading on this comprehensive page at wikipedia). A quick summary – there are 3 main stages before approval: Phase I consists of safety tests; Phase II tests efficacy at various doses, in preparation for; Phase III, which does final testing against placebo or other products.

One thing that a patient really has to understand is that there is always a chance that he/she will be in the placebo arm of the trial, in which case he/she will NOT be receiving the drug being tested. Sometimes, this may not be a big deal: in the trial I participated in, I was not too concerned about receiving placebo, as my eczema is not debilitating, and I was willing to risk being a little extra itchy for a couple months. However, the idea of putting my 4 year old in a oral allergy tolerance clinical trial requiring an entire day of hospital monitoring and a blood draw every month for 3 years really gives me pause if there is a chance he would never receive any actual tolerizing treatment. How much am I willing to put him through to combat his peanut allergy, knowing that this type of treatment is probably decades from FDA approval? In the end, changes to the protocol made him ineligible to participate, taking the weight of that decision out of my hands.

While I will soon no longer be on the medical campus on a daily basis, I do intend to keep close tabs on clinical trials in this area. I feel very lucky to have access to these opportunities to potential treatments while simultaneously moving research forward.

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2 Responses to My body for science!

  1. that’s so magnanimous of you. when i was a pregnancy counselor, recruiting pregnant ladies for studies was an everyday effort. yes it’s true that some that volunteer end up being “controls”, but controls are just as important as variables.

    my other comment is that trials for dire pediatric diseases are sometimes a little sad. there’s a difference between volunteerism and we’re-at-the-end-of-conventional-treatment-and-my-kid-is-dying.

  2. The other thing to consider is that many trials don’t have a literal ‘placebo’ arm. Many have a standard of care arm that is compared to the new treatment. For instance, with cancer- studies don’t include a placebo with zero treatment, they just use the current standard of care.

    Studies where it would be considered unethical to not treat patients, they receive standard of care.

    You could probably ask what the arms are- I’m not sure if there is a reason for study design to preclude giving patients that info. Standard of care might be a nice benefit, even if it isn’t new (it might even be better than the new treatment if that new treatment isn’t efficacious!)

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