There are 38,000 zip codes in the U.S. today. Around 70 percent of African Americans reside in 2,500 of those codes, while half of Hispanics reside in 1,500 of them. These minority populations are served by approximately 500 hospitals and 40,000 primary care physicians. Despite the concentration of these numbers, enrolling minority patients in trials remains a challenge.
Donald Trump’s advance team will soon be headed to FDA’s White Oak campus to observe and learn about the agency, to help facilitate the transition from the Obama administration to the Trump administration. In this article, I describe what I expect the nascent 2017 agenda will be as Trump’s team walks in the door, and I offer a few thoughts as to why the Trump team would do well to consider the unique nature of FDA as transition planning takes shape.
The typical relationship between clinical trial sponsors and CROs is rarely described as ‘simple.’ And few, if any, are based on the trust and collaboration that would improve efficiencies in clinical research. With over 70% of clinical trials being outsourced to CROs, and less than 10% meeting trial completion dates, the question becomes not when, but how can this critical relationship be improved to make clinical development more efficient?
Today is a big day. Today is the day your clinical protocol is finalized. Your inclusion and exclusion criteria are polished to perfection. Your informed consent form has “IRB APPROVED” stamped on it in big, bold letters. Now is the time to deliver it into the eager hands of eligible patients.
Back in 2014, a study in Nature Biotech showed that only 32% of drugs have a probability of making it to Phase 3 trials, and only one in 10 drugs overall actually makes it to market. Things haven’t improved since then. BIO recently put out a study reporting that the average overall likelihood of approval (LOA) by FDA from Phase I was 9.6 percent – a 1 in 10 chance. The rate is even lower for major disease areas like oncology.
The healthcare industry’s transition to value-based care is putting a lot of pressure on pharmaceutical companies in terms of margins and the need to demonstrate improved outcomes at lower costs. In attempting to create breakthrough therapies and “beyond the pill” solutions with fewer resources, companies are demonstrating an increased appetite for outsourcing functions – and Contract Research Organizations (CROs) could be the beneficiaries.
Increasing drug development costs, longer trial durations and insufficient rates of success are prompting the search for innovative solutions for clinical trials. As sponsors seek new ways to mitigate risks and maximize opportunities in clinical development efficiencies, many are turning to a digital collaboration platform. By Within3
Sponsors, trial managers and health outcome directors continue to obtain greater degrees of data quality, program efficiency and patient safety with ePRO. Studies show that in a typical clinical trial involving 250-300 patients over 3 months, using ePRO rather than paper to capture patient data can save as much as $150,000. At the same time, ePRO improves the trial’s efficiency and trustworthiness, yields better quality data, reduces trial length, and makes it more likely new drugs will receive agency approval.
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Pharmaceutical and biotech companies are increasingly reliant on their CROs (contract research organizations) and vendor partners to provide innovative, cutting edge solutions that will help them bring new therapies to market faster. According to a recent market research report1, the global clinical development outsourcing market will reach more than $64 billion by 2020, with CROs managing close to 72% of all clinical trials. As sponsors continue to adopt the outsourced model, sponsor-vendor relationships will play a pivotal role in the success of the clinical trial.
As clinical research evolves and becomes more refined, the industry is coming to acknowledge a simple truth: that everyone is different. A drug that works wonders for one individual may have little to no effect on, or even be detrimental to, another. Alternatively, the discovery that a treatment is ineffective or dangerous in a small group of clinical trial patients may cause the discontinuation of that drug’s development, allowing its potential to help the general population to go undiscovered.
The CSS Archiving Project s a massive undertaking, containing thousands of trials and billions of trial data pieces from 14 locations all over the world. With this project in place, World Courier will be able to take client's trial records and either return them, destroy them or archive them in a long-term storage.
My career started in clinical research. I was formerly a Study Manager and a Data Manager for a large medical device company. In the early days, we used carbon-based CRFs. We’d manage discrepancies by communicating through fax. Randomizations would be through a batch of envelopes sent to the sites. Inevitably, they’d open the wrong envelope, get the wrong randomization assignment, and you’d scramble to correct things. It was a mess, but that’s how things were run back in the day.
The Medicines & Healthcare Products Regulatory Agency (MHRA), an executive agency of the UK’s Department of Health, recently updated its definition of critical GCP inspection findings to include incomplete and inaccessible trial master files (TMFs). Specifically, the MHRA says the TMF is not compliant if it “…is not readily available or accessible, or the TMF is incomplete to such an extent that it cannot form the basis of inspection....”
Repeated inspection delays due to inaccessible and incomplete sponsor TMFs prompted the MHRA’s update – in fact, last year, 35% of commercial sponsor inspections required extra days due to an incomplete TMF or lack of accessibility. Now, adding fuel to the TMF fire, nearly 30% of inspectors in the U.K. are refusing to use paper, requiring access to an electronic TMF (eTMF) instead, according to the Drug Information Association’s 2014 TMF survey.