Clinical research is rapidly advancing in a way that can be life-changing for many. In just the past few decades, we have seen unparalleled scientific advancements leading to therapeutic breakthroughs and regulatory approvals across modalities that are altering healthcare and bettering the health, safety and well-being of patients around the world. Throughout the biopharmaceutical industry, scientists are using next-generation technologies and analytical tools to accelerate scientific discoveries and propel therapeutic development, but despite the advances in science and technology, there are common challenges across the clinical supply chain that are hindering the translation from bench to bedside.
The clinical trial landscape is complex, making it essential to streamline the clinical supply chain to accelerate the delivery of medicines to market. For clinical research labs, this often means addressing common challenges, such as eliminating contaminants, that can lead to costly delays or trial failures. For clinical trial operators, there are also challenges of patient non-adherence and recruitment and retention difficulties that require innovative solutions to move the industry forward. Furthermore, incorporating patient centricity and making trials easier on patients is crucial. The future landscape of clinical trials necessitates a shift towards innovation to find solutions for pain points that would typically slow the time it takes to go from molecule to medicine, while also ensuring that the patient experience is as seamless and supportive as possible.
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Innovative solutions to alleviate common challenges of contamination
Contaminated biomaterials in clinical research labs can cause significant problems for any lab that works with cell cultures. For example, mycoplasma is a strain of bacteria that can contaminate cell cultures, bioprocessing fluids and biological samples, and it’s often difficult to detect and remove from cultures once it’s been introduced. According to the American Type Culture Collection, mycoplasma contamination is common, affecting between 15 percent and 35 percent of all continuous cell cultures.1
Mycoplasma contamination alters cell physiology, such as stunting growth or slowing metabolism rates, which in turn can create inaccurate data and delay experimental outcomes. As such, avoiding mycoplasma contamination is a top priority for clinical trials to ensure patient safety and accurate data.
Clinical trials are not the only point in the clinical supply chain that mycoplasma contamination can occur. It can also impact biopharmaceutical manufacturing. If mycoplasma contaminates samples or end products at any point throughout the clinical supply chain, it can extend timelines, increase costs, and significantly delay therapeutic development.
Given that mycoplasma can be introduced into biomaterials through a variety of avenues, it’s critically important that the biopharmaceutical industry has testing solutions that are accurate, easy to use, and offer a high level of sensitivity with high throughput. Since the 1990s, mycoplasma testing has been required by the FDA and the industry has been using compendial mycoplasma test methods that are labor-intensive, offer low sample volumes, and take roughly a month to complete.2 While this was considered the gold standard technique for decades, there are innovative, polymerase chain reaction (PCR)-based techniques, such as the nucleic acid amplification technique, that are now considered a viable alternative approach. These approaches have several advantages over established techniques, such as improved sensitivity, faster run times, larger sampling size, and greater scalability. For example, PCR techniques can be completed in one day whereas traditional methods take either nine or 28 days to execute. Furthermore, the PCR technique offers up to a 10-fold increase in sensitivity. And finally, PCR techniques can be automated for ease of use regardless of a scientists’ experience level.
Prioritizing safety throughout the clinical trial supply chain
The rise in chronic diseases, such as cancer and neurodegenerative diseases, has led to an increased demand for advanced therapies that are safe and efficacious. Regulatory bodies around the world have strengthened requirements for drugs throughout the biopharmaceutical value chain, including increased testing mandates for the presence of pathogens like the aforementioned mycoplasma in clinical research, during clinical trials and when manufacturing drug products.
Prioritizing safety with patient-centric solutions is crucial for clinical trial operators. Next-generation technologies, such as artificial intelligence (AI), and smart technology like remote monitoring sensors and intelligent packaging can simplify patient participation while enhancing data collection accuracy.
Artificial intelligence: AI offers real-time patient monitoring, helping clinical trial operators track patients' adherence to medication protocols and adjust supply levels accordingly. This approach broadens participation and ensures that collected data reflects our diverse population, validating the safety and efficacy of therapies across groups.
Smart technology: Smart packaging solutions support remote patient monitoring and adherence through remote visibility and reporting, which means that patients can save time through fewer office visits and clinical sites can prioritize interventions based on adherence dashboards. For example, smart metered-dose inhalers equipped with built-in sensors can track consumption patterns and daily use, and smart sharps containers can track injection adherence. There are also tabletop pill-dispensing devices with programmable alerts and reporting capabilities, which can even remind patients to record their blood pressure and then have the reading sent to research teams. Utilizing innovative, direct-to-patient services and smart technologies ensures that patients receive investigational drug shipments without needing to travel to a medical center, thereby increasing trial accessibility.
The path toward clinical trials of tomorrow
Clinical trials play a vital role in shaping the future of medicine, and given their impact on our modern world, clinical research labs, trial operators, service vendors, and manufacturers have a unique role to play in making our world healthier, cleaner, and safer. To ensure that safe and effective treatments reach the market as quickly as possible, the clinical trial industry must embrace innovative tools and technologies that increase efficiency while prioritizing safety and patient centricity. More reliable biosafety testing methods allow clinical research labs and biopharmaceutical manufacturers to safely work with biomaterials, and digital solutions can help clinical trial operators gather more representative data to develop safer therapies. Embracing innovation across the clinical trial supply chain not only enhances speed and agility, but also helps prevent the impact of supply chain disruptions. This approach addresses common challenges that have historically posed roadblocks, enabling the biopharmaceutical industry to achieve its overarching goal of delivering life-changing therapies to patients as swiftly as possible.
References
- “Mycoplasma Contamination.” American Type Culture Collection. https://www.atcc.org/the-science/authentication/mycoplasma-contamination.
- Zoon, Kathryn C. “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993).” US Food and Drug Administration. https://www.fda.gov/media/76255/download.
