Achieving patient diversity in clinical trials has long been challenging, and thus approved products may not be appropriately tested on representatives of the patient populations who end up using them. Even in conditions such as type 2 diabetes that impact ethnic minority populations in disproportionate numbers, racial and ethnic minorities are typically underrepresented in clinical research data. Some, however, are not seeing significantly lower minority interest in clinical trials relative to the percentage of minorities in the population. This suggests there is no underlying hesitancy or trepidation by minorities.
With the site-first approach to enrollment feasibility and completion continuing to struggle, sponsors are recognizing the need to embrace a patient-first strategy in order to complete enrollment on time or early. This requires truly understanding the patient as a potential trial participant relative to the study protocol, and owning the full patient experience, not just the trial journey.
Phase I is often seen as the gateway between scientific research and clinical medicine, and the outcome of the trials have a major impact on the next steps of any prospective drug.
The ongoing advances in cancer immunotherapy together with precision medicine may promise a bright future for patients. Learn about the two most common biomarkers in clinical trials that are critical for the drug development process.
When it comes to the conduct of pediatric clinical trials, there are number of things you need to consider in order to ensure the successful conduct of a study. While we can’t predict the outcome, planning ahead for appropriate site conducting clinical studies in pediatric patient populationsand subject selection will take you one step closer. From study design to logistics to recruitment, there are real differences between studies conducted in pediatric populations and studies conducted in adult populations.
Medical research has seen a great deal of high-profile philanthropic investment in recent years. Last year, for example, tech billionaire Sean Parker made a $250 million donation to further the development of immunotherapy. More recently, the Chan Zuckerberg Biohub has made headlines by announcing plans to invest $3 billion in new research over the next 10 years. The investment is part of the Biohub’s ambitious goal of curing all disease by the end of the century. It will be directed toward a wide array of medical solutions including new drugs, vaccines, and diagnostic tests - and the first round of grant recipients has already been chosen.
For clinical trials to be truly successful, adherence to protocols is essential. However, as trial designs become more complex, sponsors are seeing a worrying fall in compliance levels amongst both investigators and patients. Learn about the reasons for the drop in compliance and how mobile technology can help reduce the burden on all involved and increase compliance and data quality.
Investigative sites are the heart and soul of clinical trials, essential to ensuring the efficacy and safety of pharmaceutical compounds in humans. Site selection is pivotal to the successful execution of clinical trials, which are not only long and bureaucratic, but are also experiencing diminishing returns1. Studies estimate that it costs upwards of $2B dollars to bring a new drug to market,2 with daily revenue losses in the range of $1M to $8M3 due to delayed market entry.
Competing studies can be a challenge when enrolling patients in clinical trials. However, when those studies are conducted by an individual sponsor, the need to engage with a single patient population can quickly turn into an asset and result in substantial savings.
Anyone with an involvement or interest in clinical research is likely to be aware of the challenges sponsors face in getting their compounds approved by the FDA. The low rates at which drugs make it all the way through the research process is a favorite topic of blogs and journalistic outlets covering clinical research. Many of the drugs that fall by the wayside suffer that fate because of unfavorable efficacy data in the middle and later phases.
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