![]() ![]() ![]() False starts due to missed SIV dates have an immediate impact on trial timelines and, ultimately, profitability for sponsors. Every member of staff should be armed with the correct policies and procedures – as well as fully calibrated and ready equipment – to commence research activities on the site initiation visit (SIV) date. 5įrustratingly, site initiation delays are common. ![]() In recent times, end points in trials have doubled, with the average number of procedures per participant increasing by 58%. Similarly, increasing complexity, and interdependencies between agencies and across borders, puts greater demands on project managers to meet deadlines. We explore some of the common reasons why clinical trials experience delays, and what you can do to avoid them.Ī Nature analysis examining the causes of clinical trial delays found that strategic problems, commercial barriers, and operational issues were to blame in almost a quarter of all trials. And delays in getting drugs to market means delayed treatments, potentially effecting patient outcomes. Hold ups may place an unnecessary and unwanted burden on patients, which could lead them to exit trials, further exacerbating the problem. ![]() While it’s important to recognise the financial implications of delays, there are some human implications too. Estimates vary, and are contested, but whether measured in pounds, euro or dollars, the amount of money lost in clinical trials delays is in the billions, and increasing year on year. 2īesides the immediate impact on clinical trial budgets, delays can impact the long-term profitability of a drug by reducing its patent window. 1 The financial impact can be massive, costing between $600,000 - $8 million every day. Here is why managing time, resources and participants are essential in avoiding delays and delivering results.Īn estimated 85% of all clinical trials will experience delays, with 94% being delayed by over a month. See the 10-page pitch deck that convinced NEA to make its first investment in the booming clinical operations industry.A huge majority of clinical trials face delays, costing precious time and money, as well as impacting patients. The presentation has been lightly edited by Slope to remove confidential financial, customer, and go-to-market information. Slope provided Insider with the presentation it used to raise $20 million from NEA. That will be something we all have to live with." "You just can't go back to a fully in-person, on-site environment. "You can't put Pandora back in the box," Wu said of the seismic shifts in the trials industry. He ended up meeting with Slope as a prospective customer, not an investor. Other software he saw focused too much on the virtual element of decentralized trials, he said, and he was looking for a company that could tackle the logistical challenges of running trials virtually and in person across several labs in the US. Wu also invests in biotechnology companies, many of which run clinical trials of their own and experienced the disruptions of lockdowns firsthand. It also helps labs cut costs associated with running and operating a lab while seeing patients in person. For one, it substantially cuts down on travel time for patients, many of whom drive hours to an academic or research hospital to participate. Now that clinics have reopened, many have opted to stick with virtual or decentralized models, Blake Wu, an NEA partner, told Insider. To salvage many trials' data, some research clinics started conducting the studies virtually, which is now known as decentralized clinical trials. It's NEA's first foray into the clinical-trials space, which started to boom once the COVID-19 pandemic highlighted the restrictions and costs associated with traditional in-person trials for new drugs and therapies.ĭuring the initial phase of US lockdowns, many in-person research labs closed their doors, stalling years' worth of research and trials for the billion-dollar pharmaceutical industry. NEA invested in Slope, a startup that offers ready-made lab kits and tracking software to researchers running clinical trials across the US. One of Silicon Valley's leading investment firms just made a $20 million bet on the red-hot clinical operations industry.
0 Comments
Leave a Reply. |