Hello Reader,
My name is Dr. Mahelona, and I am a mental health doctor and researcher with Evolution Research Group. I am writing this article to inform you about clinical research and opportunities for opioid use disorder in a safe and easy to access way. Several of our clinical research sites are conducting groundbreaking research into alternatives to opioids and treatments for opioid use disorder so that future generations have other options. If you are interested in learning about how to be part of this change, please reach out to us for a brief conversation and assessment to see if you are a good fit for a clinical trial! In addition to telling you about these interesting opportunities, I would like to spend some time teaching about one of my passions; clinical research and the process of becoming a well-informed participant.
I believe the world of clinical research has untapped potential for many people and healthcare providers. Most of those who seek medical care dont know that clinical research is a safe and cost effective (paid participant, actually) way to seek treatment for their illness, receive health monitoring, and contribute to the development of more effective and safer treatments. In this article, I hope to discuss the process of medication approval and present several important ideas to consider before participating in a clinical trial. Firstly, I will talk about the process that takes place before new medication is available at your local pharmacy.
Before a doctor can prescribe you a medication, the medication must first gain FDA approval; many (most, actually) medications are used for purposes other than their FDA approved conditions, but they still must go through a rigorous process to show that they are reasonably safe and helpful before making it to the pharmacy. Before a medication is approved, it is studied extensively. First in non-human models, then with healthy adults, and finally those with the illness it is meant to treat. During this final phase, individuals are monitored very intentionally to learn about the potential medications ability to treat the individuals ailments. Some participants in this phase are given a medication and others may receive a placebo; placebo looks just like the active product but does not contain any active medication. Researchers use this approach to make sure that the new medication is more effective at treating the disease than the placebo. Generally, a medication doesnt belong in the pharmacy if it does not work better than the placebo. Once the data is collected during this phase, the FDA critically assesses the information and decides how to proceed. We hope that the data is convincing and earns the medication the coveted status of “ approved” so that may be considered a new treatment!
As you might imagine, a study participant is a very important person in this process and their safety is the highest priority. Before a participant can agree to be part of a clinical trial, they must be able to demonstrate understanding of the risks, benefits, and alternatives to doing so; this is an ethical cornerstone in the world of clinical research. Participating in this process is a big decision for the researcher and the participant; one that I take very seriously and discuss with every person who considers being in one of the studies I have agreed to conduct.
Some of the important things that I always discuss with individuals before participating in a study are summarized below:
· Potential benefits
o Access to new, potentially more helpful, medications
o Detailed evaluation of your health with frequent and careful monitoring
o Contribution to the advancement of medical science
o Compensation for your time and travel
· Potential risks
o Receiving a placebo for your ailment instead of treatment
o Experience of unknown adverse effects from the investigational product
Once an individual understands these basics risks and benefits and are deemed eligible to participate, they are ready for the next phases of participation in a clinical trial. This next step involves a detailed consent process that covers the scheduled activities in a study, risks of participating, and details about compensation.
To conclude, clinical research offers a unique opportunity for individuals to not only access innovative treatments but also contribute to the development of new, effective therapies for conditions like opioid use disorder. While participating in a clinical trial is a significant decision, it can provide access to new medications, thorough health monitoring, and the chance to shape the future of healthcare. It is essential that participants are well-informed about the risks, benefits, and alternatives before agreeing to take part, and I take great care in ensuring that every individual understands these factors. If you’re interested in exploring clinical trials or learning more about how you can be part of this important change, please don’t hesitate to reach out. Your involvement could make a lasting impact on healthcare for generations to come.
