When The Goal Is Observation: Beyond Experimental Clinical Trials
One of the most common myths about clinical trials that we at FindMeCure work hard to dispell is that clinical research is only about experimenting with new treatment methods. If you follow our blog, you already know that there are other purposes to clinical trials and not all of them involve medical interventions. Healthy volunteers can donate a little of their time to research by participating in observational clinical trials and help to further scientific understanding about their lifestyle, nutrition or even interpersonal relationships.
Observational studies have their pros and cons when it comes to the outcomes of their efforts. When it comes to proper nutrition, in particular, observational studies can sometimes imply causality where there is none – or at least that’s how the headlines make it seem. Today you can read that a plant-based diet adds years to your life and tomorrow – that dairy can lower the risk of cardiovascular disease. Who do you listen to?
If you’re looking to new research in nutrition (mostly observational studies) to make the best decisions for your health, you may be neglecting to acknowledge some of the underlying biases. People on plant-based diets, for example, are typically more inclined to participate in other health-promoting activities such as yoga, involvement in a community, limited alcohol consumption and they’re also less likely to smoke. These predispositions need to be accounted for if the observational study is to come up with meaningful interpretations of the collected data.
Observational studies followed by controlled trials are usually more trustworthy as the hypothesis of the observational study was put to the test against a control group. To form this hypothesis in the first place, however, observational studies are invaluable and the medical world needs them to further progress.
Less expensive to conduct than clinical trials, observational studies can follow volunteers for years or even decades to collect important data. The sample group can include tens of thousands of participants to make the study statistically relevant when it comes to such things as disease outcome, lifestyle and habits, environmental exposure, etc. As long as we remember that observational studies can’t clearly show cause-effect relationships, we can interpret the data for many different purposes, including the construction of an experimental trial. Observational studies can’t always take into account all possible factors and often rely on self-reports (which is especially the case in psychology research) but as long as researchers know what to look for, the data can spark interesting conversations and lead to some long-awaited innovations.
So what are observational trials researching right now? With 4721 observational trials being conducted all over the world, it’s hard to narrow down the focus to just a few issues researchers are interested in. Nutrition will always be a topic of interest just as infertility is, alongside disease outcome, healthy lifestyle and the impact of bad habits – it was an observational study that found a link between smoking and lung cancer.
If in your mind clinical trials only deal with disease and medication, prepared to have your biases shaken. An observational study in Williamsburg, Virginia is looking to evaluate the short-term outcomes of the Investing in Fatherhood: New Pathways program of Child Development Resources (CDR), a Healthy Marriage and Responsible Fatherhood (HMRF) program. The program is trying to equip adults in several main spheres by delivering parenting education, relationship skills training, job preparedness and financial planning.
Another observational trial interested in interpersonal skills and the development of healthy relationships is trying to assess the outcome of the HMRF grant-funded Connections program. The program is a continuation of its successful predecessor which teaches single and partnered participants with substance use disorders (SUD) the skills needed to “(1) create and/or sustain healthy relationships/marriages, (2) (…) raise children in a functional and healthy environment, (3) improve their financial stability, job readiness and employability to improve economic self-sufficiency and responsibility, and (4) reduce relationship stress and strain on interactions between co-parents.” Science isn’t only interested in our physiological health but also in the health of our relationships as it adds to our quality of life and overall wellbeing.
Further proof of that is this observational study in the Bronx, New York which aims at evaluating the outcome of a program that provides “an array of relationship promotion activities incorporating case management and job placement/career advancement activities”. The program is interested in enhancing relationship satisfaction by teaching participants important marriage and divorce reduction skills.
Interpersonal relationships aside, quality of life has to do with a variety of different factors among which are mental health and proper nutrition. An observational trial in Bethesda, Maryland is looking to establish connections between habits in childhood and eating behaviour and health. The study is interested in different factors such as sleep, mood, thinking skills, and genetics in order to identify children at higher risk for eating-related health concerns.
A better understanding of PTSD is the objective of another observational study. What researchers are trying to do is find a physiological basis reflected in the stress-related proteins in the interstitial fluid and plasma in order to find a biomarker to support PTSD diagnosis. What this could mean for the future of healthcare is an opportunity to personalize treatment based on the biochemical phenotype of PTSD patients.
Observational trials can aim at improving diagnostic methods, noninvasive treatments as well as evaluating health risks linked to certain deficiencies or unhelpful habits. Such is the case with this trial testing the diagnostic method of Applied Kinesiology. “Professional Applied Kinesiology (PAK) is a system which attempts to evaluate numerous aspects of health (structural, chemical, and mental) by the manual testing of muscles, combined with other standard methods of diagnosis.” Such an approach leads to a variety of holistic conservative treatments among which dietary management and counselling. We have always supported balanced treatments that focus on different health factors in order to contribute to the patient’s general quality of life. Observational studies may hold the key to evaluating and choosing the best diagnostic as well as treatment methods to achieve this healthcare goal.
In some instances, this kind of studies observe participants who have been diagnosed with a particular disease as opposed to healthy volunteers. When this is the case, the trial remains non-invasive (hence, observational) but it still might look into the outcome of a certain treatment or lifestyle change that the volunteers participate in on their own accord, i.e. it’s not administered by the staff of the trial. A recruiting study in Durham, North Carolina is looking for both healthy participants and estrogen receptor-positive breast cancer patients to evaluate “the effects that standard of care endocrine therapies have on the immune system’s response to cancer by looking at the number and types of immune cells present and how they function in women with early-stage estrogen receptor-positive (ER+) breast cancer”.
As you can see, the world of clinical research is far from the stereotype of the scientist in a lab testing experimental drugs. The processes behind clinical trials are both more complex and more precise than that and the data collected by research holds the answers to many of our modern-day health concerns. You can still donate your time to research as a healthy participant – just find an observational study near you and volunteer to help researchers further their understanding of a particular issue that’s also of interest to you.