Clinical trials have become more complex than ever. Although there is still some debate around exactly how complex they have become, trials today seem to have more endpoints, procedures, eligibility criteria, protocol amendments, and investigator sites than just 10 years ago. Add adaptive trials to the mix, and clinical supply executives have more to worry about than ever before. Perhaps it’s time to make your clinical supply chain as flexible as your trials.
In clinical trials involving patients with complex medical diseases such as chronic kidney disease or cancer, nursing skills are especially useful. Nurses are trained on how to interact with, evaluate and appropriately care for, patients. They are familiar with complex medical regimes and are comfortable talking with and educating patients.
Patient centricity is a growing trend in our industry. From the creation of Chief Patient Officer positions to culture-change initiatives, one of the strategies to improve the quality of clinical trials is to treat patients as “consumers” rather than “subjects” in a study.
There is a direct correlation between innovations in modern medicine and clinical trials. Researchers and their sponsors continue to push what is possible with new forms of life-saving therapies enabled through cutting-edge science and good, old-fashioned trial and error. Modern medicines improve quality of lives. Clinical trials improve the quality of modern medicines.
In part one of this series, we examined the history of companion diagnostic approvals by FDA and identified trends to suggest better approaches to optimize the review process. Here, we will analyze new avenues sponsors may consider to further streamline the review of these important products through the assessment of various regulatory submission types and FDA guidance.
In this article — part one of a two-part series — we will examine the history of companion diagnostic approvals by FDA. Through this process, trends can be identified to suggest better approaches to optimize review times.
Over the years, an entire system called ‘cold chain supply (or cold chain transport)’ has developed in the food industry to ensure that foods that need to be kept cold are stored and transported in appropriate conditions and are monitored so consumers and regulators can be assured of their safety.
Vaccines, one of the most useful and cost-effective means of reducing illness and death from infectious diseases, are enjoying a resurgence of interest that some have pronounced a renaissance. With hundreds of vaccines in research and development worldwide, vaccines are among the fastest growing segments of the biopharmaceutical market today.
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Novel therapeutics such as gene and cell therapies, nanoparticles, and combination products requiring targeted delivery, novel treatments for wound healing, cardiovascular disease, and bone regeneration, and new medical device technologies call for innovative surgical procedures in preclinical trials to determine safety and efficacy.
I recently had the opportunity to attend DIA. While listening to the panelists, I realized TransCelerate companies appear to be the furthest along in their journey of risk-based monitoring (RBM), and even so, RBM is still relatively new for most of them. For the companies presenting at DIA, the main reasons given for implementing RBM were to comply with the impending ICH E6(R2) guidelines, increase the overall quality of their data, provide better oversight of patient safety and target their efforts on the areas of trials that matter most.
The clinical trial process plays an essential role in drug discovery by effectively demonstrating the efficacy and safety of a pharmaceutical compound. Unfortunately, current estimates show that only about 1 in 10 drugs that actually start the clinical trials process are eventually granted FDA approval.
There is no doubt that clinical research is critical to the advancement of medicine and public health. But conducting such research is a complex, resource intensive endeavor that relies on a multitude of stakeholders, workflows, processes, and information systems.
Electronic Data Capture (EDC), which collects clinical trial data electronically rather than on paper, is becoming an increasingly popular solution for streamlining data processing.