Clinical trials play a critical role in the broader landscape of medical research. They are scientifically designed studies, carefully planned and executed under strict regulatory oversight, aimed at answering specific questions about a medication or intervention’s safety, efficacy, and interactions within the human body.
At its core, a clinical trial is essentially a rigorous, stepwise process, meticulously graduated into three distinct but integrative phases. Each phase serves an important purpose in the journey from laboratory research to a drug or treatment approved for use in wider patient populations.
Phase 1 Clinical Trials
In Phase 1 trials, the initial leap is taken from the lab to the clinic. This phase is primarily about establishing safety. A small group of healthy volunteers, typically less than a hundred, receive the intervention. Researchers closely monitor these individuals to identify any adverse reactions, determine a safe dosage range, and identify potential side effects. The benefits of participation in these trials for patients on the breast cancer journey is somewhat limited.
Phase 2 Clinical Trials
The baton is then passed to the Phase 2 trials, where the focus shifts from safety to effectiveness. In this phase, the intervention is administered to a larger number, up to several hundred individuals, who have the specific condition the drug aims to treat—in our context, it would be breast cancer. The aim here is to better understand the intervention’s impact on the disease, measure the outcomes, and extract data on short-term side effects and risks.
Phase 3 Clinical Trials
Phase 3 trials are where the stakes get exponentially higher. Thousands of patients are involved, as this phase seeks to confirm the effectiveness of the new intervention discovered in Phase 2, monitor side effects, compare it to existing treatments, and collect information that will allow it to be used safely. A positive outcome at this juncture paves the way to regulatory approval and general availability of the drug or treatment.
So where do women with breast cancer fit into this clinical trial universe? Participation in a clinical trial offers the possibility of accessing new and potentially more effective treatments not yet available to the wider public. It also ignites the beacon of hope for future generations of patients, contributing to the advancement of medical knowledge and the development of more effective treatments. The opportunity to actively take part in their own care pathway can be empowering.
However, it’s important to remember that signing up for a clinical trial should never be rushed. Thorough discussions about the potential pros and cons with healthcare providers are essential. And, of course, it’s vital to understand that the outcomes of clinical trials are never guaranteed.
That said, in my experience, and in the experiences of the other women I spoke to who participated in trials, it gave us a sense of proactive engagement and purpose in our breast cancer journeys. I know women with stage 4 breast cancer who have been able to leverage multiple clinical trials to keep their disease stable, prevent progression and extend their lives.
Lastly, diversity is of utmost value when it comes to clinical trials. Every woman’s story and treatment plan is different and the clinical trial participants must reflect those differences. For instance and unfortunately, black women are significantly underrepresented in clinical trials, meaning we need to address the social, economic, and structural barriers, and communication and access issues that prevent wider participation.
I hope more of us consider clinical trials as a part of our healing process. It’s a far-reaching decision, not just about the safety and efficacy of drugs, but about hope and unity, about being part of an arduous yet important journey towards better treatment methods for breast cancer.
