Beyond the Bench: Demystifying Clinical Trials and the Future Role of Community Pharmacy

Clinical trials are the backbone of modern medicine, serving as the essential gateway through which new treatments must pass to ensure they are safe and effective for widespread public use. Yet, the process often seems mysterious, complex, and highly institutionalized. We sat down with Austin Tull, a licensed pharmacist with extensive experience overseeing large clinical trial sites, to peel back the curtain on how these crucial studies operate, what challenges they face, and how community pharmacies are stepping up to revolutionize patient engagement.

Teresa: Austin, thanks for joining us today. To start, could you share a bit about your background in clinical trials and your qualifications to discuss this complex topic?

Austin: Sure, absolutely. I am a licensed pharmacist in Georgia, and my career path through community pharmacy, hospital pharmacy, and compounding ultimately led me into clinical trial research. I previously oversaw a clinical trial site as the Director of Pharmacy and Lab. This was a pretty sizable organization, overseeing about 100 active studies, focusing primarily on psychiatric medications but also covering everything from Women’s Health to Parkinson’s.

Teresa: It sounds like you have extensive experience. Can you explain exactly what a clinical trial is for our readers?

Austin: Yes. A clinical trial is the primary way researchers determine whether treatments are safe and effective before they are used widely. The results from these trials are critical; they are used when researchers apply to the FDA for commercial approval. These trials can focus on a novel proposed drug or on an existing drug for a new clinical indication. Crucially, all trials must be approved by an Institutional Review Board (IRB). Every patient must undergo an informed consent process in which they are educated about the potential side effects and how the trial process works, and they must sign off on their understanding of these requirements.

Teresa: That foundational understanding is essential. Moving on, can you explain the different types of trials researchers employ?

Austin: Certainly. The gold standard is the double-blind placebo-controlled study. In this scenario, “double-blind” means neither the researcher (usually a medical provider) nor the patient knows if the patient is receiving the active drug or a placebo. This is done specifically to prevent bias in the results. For example, if a doctor knew a patient was receiving a placebo, they might treat the patient’s reported side effects less seriously, which would inherently skew the end results. “Placebo-controlled” means there is a control group receiving a placebo, which typically looks exactly like the active medication but is often just a sugar pill or an inactive ingredient, allowing us to compare clinical results, side effects, and observations between the active and control groups.

Another common type is a single-blind study, appropriate when the researcher knows the treatment but the patient remains blinded. Most studies are randomized controlled trials, where patients have an equal chance of being placed in the active or control group, which prevents any single site from unduly skewing the data. There are also crossover trials, where patients are randomized to active or placebo, then enter a washout period, and then “crossover” to receive the opposite treatment. This allows comparison of outcomes within the exact same patient receiving both the active and placebo treatments. Finally, open-label trials are common in later phases when blinding is less necessary, and both the researcher and the patient know the treatment being received.

Teresa: Can you provide a brief overview of the typical four phases of an investigational study?

Austin: The phases are typically just phase one through phase four. Phase one tests safety, dosage, and side effects. This phase usually involves a small group of healthy volunteer participants, and researchers observe them to determine effective doses or doses that cause severe side effects, prepping for subsequent phases. Phase two then evaluates how well the drug works in people with the actual condition. For instance, if Phase one tested a Parkinson’s drug on healthy volunteers, Phase two tests the drug on patients with Parkinson’s disease to assess their response and side-effect profile.

Next is Phase three: larger-scale testing to confirm effectiveness, continuously monitoring for side effects, and critically, comparing the new treatment to existing treatments. It’s worth noting that many studies today combine phases two and three, provided the IRB approves, which saves the pharmaceutical company time and money and speeds up the overall process. Finally, phase four is post-marketing surveillance. After the drug receives FDA approval and is introduced to the broader public, this phase monitors for any dramatic increase in new side effects that were previously only recorded in a small subset during earlier clinical trials.

Teresa: The patient plays a significant role in the success or failure of a trial. What are the key elements of that role?

Austin: The patient’s role is vital. The key to success is for the patient to understand the expectations outlined in the informed consent process fully and to maintain open communication with the research staff. Patients often have requirements like periodic check-ins, blood draws, and self-monitoring. If the patient experiences any lapse in these responsibilities, the trial results can be skewed, or their entire data set might have to be thrown out.

The primary benefit for participants is access to novel medications for conditions they are suffering from. Many trials require patients to have tried and failed several other treatments, making access to an unreleased product potentially their saving grace. Patients also receive close monitoring, which is often above and beyond what they would receive from a primary care or specialist office. However, the major concern is negative reactions or side effects. Since a novel chemical may have limited real-world data, the requirements for informed consent and IRB approval are paramount. These requirements can also be a significant time burden, with numerous in-office visits and blood draws.

Teresa: Considering the time burden and other factors, what do you see as the biggest challenge in clinical research today?

Austin: I would say the most significant challenge encountered by clinical trials is finding participants who qualify and will commit to the entire trial period. I feel that this issue is universal. High dropout rates are a major concern for trial sponsors because significant time and money are wasted on the onboarding process for participants who leave early. Many patients are brought into clinical trial sites without any previous relationship, which is a major factor contributing to high dropout rates.

Teresa: This leads us to the innovative approach being championed by RxE2: expanding community pharmacies’ involvement. What benefits come from engaging a community pharmacy?

Austin: The benefits are profound. Community pharmacies are uniquely positioned because they can identify potential patients within their existing customer base. These patients already have an established, trusted relationship and connection with that pharmacy, which is paramount for retaining and completing a successful trial. Furthermore, community pharmacies are one of the most trusted healthcare professionals and offer a diverse patient population. Instead of requiring a patient to take a dedicated, sometimes long, trip to a clinical trial site, the pharmacy’s close proximity can be the difference between a completed trial participant and a patient lost to follow-up.

Teresa: Looking ahead, do you think incorporating community pharmacies will become a mainstream approach for successful patient retention?

Austin: Absolutely. Because typical clinical trial sites often feel corporate and impersonal, having the community pharmacy involved is a much more attractive option for patients curious about participating. Since dropout rates are the most concerning aspect for trial sponsors, their motivation is clearly aligned with finding higher retention sites that can efficiently produce data. This is an exciting opportunity. Partnering with platforms like RxE2, which create software integrated into the pharmacy workflow, is really what needs to be done to kick-start this movement of community pharmacies working directly with trial sponsors.

The landscape of clinical trials is changing, recognizing that establishing trust and convenience is key to overcoming the universal challenge of patient retention. As Austin Tull pointed out, community pharmacies are stepping into a vital role, transforming the clinical research process from an impersonal, distant endeavor into one that leverages existing relationships and highly trusted healthcare professionals. This innovative approach promises a future where clinical research is more accessible, efficient, and ultimately, more successful in bringing life-saving medications to the market faster.