The success of a clinical trial often depends on attracting the appropriate participants so that the sample reflects the general population. But how to ensure that this is the case? We’ve found some of the major problems with clinical trial diversity and how to solve them. Who is Represented? Studies indicate that many trials under-represent women, people of colour, and…
The USA Orphan Drug Act of 1983 created incentives for pharmaceutical companies to research and create new drug therapies for rare diseases. These incentives include tax breaks, exclusive marketing rights, unique research grants and fast-tracked FDA review processes. As a result, the clinical costs associated with the development of an orphan drug are less than those associated with non-orphan drugs1….
Clinical trials are fundamental to testing new medicine, investigating existing medicine and improving healthcare. Most research protocols are either designed by researchers employed by the pharmaceutical/ medical device company or investigators from academic institutions. Here are six things that distinguish industry clinical trials from academic clinical trials: Funding – Industry-initiated clinical trials are financially supported by the industry. The primary…
Study non-adherence is an ongoing problem surrounding clinical trials. Noncompliance drives up research costs and increases the time it takes new medicines to make it to the market. One study suggests that costs associated with noncompliance are as high as $1.5 billion by the time the investigational product (IP) is fully developed 1. Considerate IP packaging is one way researchers…
In 2016 the United Kingdom (UK) held a national referendum in which the country voted to leave the European Union (EU). Since then, the UK and the EU have been negotiating an agreement that outlines the terms of the UK’s withdrawal. With uncertainty about the terms on which the UK will leave the EU, it is important to consider how…
Clinical supply chain logistics are constantly changing as new technologies and developments are adapted. While multiple factors are responsible for reshaping the clinical trials logistics landscape, the explosive evolution of biologics is the key driver. In order to preserve the integrity of biologics and other highly sensitive medicinal products, as well as maintain the validity of trial results, cold chain…
Finding ways to improve efficiencies and manage the increasingly uncertain and complex clinical trial supply chain is a high priority for the pharma and medical technology industry. Annually, $20 billion of R&D spending is essentially wasted due to poor clinical trial management and planning. Based on our experience with supply chain logistics management, we have identified some innovative approaches and…
Over recent decades, the heightened awareness of sustainability issues among consumers, combined with the prevalence of corporate social responsibility and an increase in regulatory standards, has put pressure on the clinical trial and pharmaceutical industry to reduce the environmental impact of its activities. The potential benefits from creating a greener clinical supply chain includes an enhanced brand reputation and operational…
