Statistics suggest that Phase I clinical trials, while by no means free of challenges, are more manageable than later phases. They tend to take less time and cost less money; the drugs they test have a comfortable 70% chance of moving on to the next phase.(1) These figures are a reprieve from some of the realities that make Phase I trials, in some respects, uniquely stressful. The absence of a safety profile for the drug being tested can make subject recruitment particularly challenging. And any errors or delays in Phase I can set the tone for the rest of the drug development process.
A drug’s journey from proof of concept to FDA approval is a years-long, far-reaching process in which healthcare, business and government each play important roles. For aspiring clinical researchers hoping to navigate this sprawling field, there’s certainly a lot to learn. We thought we’d take a look at a pair of initiatives educating students in healthcare and pharmacology in the many aspects of clinical research. Driving these initiatives is the understanding that clinical research shouldn’t be a niche skill, that strengthening knowledge of clinical research among all kinds of healthcare providers will strengthen the healthcare industry as a whole.
Leading manufacturers increasingly employ stakeholder research early in development to better identify the needs of patients and providers.
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.
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.
Metabolic diseases (e.g. obesity, type 2 diabetes, and hypertension) are a rapidly expanding health care concern. Although there is a high demand for novel therapies, the challenges are substantial as existing drugs typically fail due to lack of efficacy or safety, and clinical studies often extremely large and protracted.
Cancer continues to be a formidable disease with an overall success rate of bringing new drugs to market of only 5-8%.
An international pharmaceutical company approached Camargo Pharmaceutical Services to help navigate the Food and Drug Administration (FDA) 505(b)(2) approval pathway for a promising drug under development designated for patients with cardiovascular disease. Product X is a prodrug that is converted in one metabolism-dependent step to produce the active metabolite of an approved drug.
A large pharmaceutical company with globally distributed preclinical R&D operations including externalized services implemented an advanced assay/ study tracking and optimization system in conjunction with its enterprise electronic lab notebook.
PRA is a global Clinical Research Organization providing services through all phases of clinical development. PRA has supported over 3,100 clinical trials in more than 80 countries on 6 continents through our global offices. PRA's therapeutic expertise, global reach, and project experience with local knowledge enable our project teams to deliver consistent and on time performance for our clients.
MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries.