Early Clinical Development Part 1

| July 13, 2016

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TranScrip has extensive experience across the Infectious Diseases area, including antibacterials, antifungals and antivirals. TranScrip has supported small to large pharma companies in licensing and funding activities.

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DHelix Group

Double Helix thrives on unravelling complex challenges to create solutions that make a difference in healthcare. We are a team of trusted advisors who help our clients make the right strategic decisions. We do this through two strands: Discovery and Consulting.

OTHER ARTICLES

What to Watch in 2020: Non-Specialty Drugs

Article | March 1, 2020

Pharmaceutical manufacturers are constantly working to develop new and improved medications. Join us as we explore the non-specialty drugs you should be watching in 2020. If you missed last week’s article about the most important upcoming specialty drugs, be sure to check it out here. Approximately 40 new medications are approved by the Food and Drug Administration (FDA) every year.1 (Please note: If you’re curious about what it takes to develop a drug and bring it to market, check out our previous article). Why should you care about these new medications? Because they can affect both your organization’s pharmacy spend and your members’ cost share. For non-specialty drugs, we will focus on medications that may come to market this year, including ones that are currently being reviewed by the FDA, or that are in the last clinical trial (Phase III) stage.

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Artificial intelligence in pharma: utilising a valuable resource

Article | March 11, 2020

The pharmaceutical industry is set to greatly benefit from the use of artificial intelligence (AI), due to its wide range of applications. Sydney Tierney discusses how machine learning can enhance marketing, manufacturing and drug trials. Artificial intelligence (AI) can be applied to nearly every aspect of the pharmaceutical and healthcare industry, to enhance data processing. Adopting the technology will reveal the astonishing potential of the healthcare sector, with success rates flying higher than ever before – especially in the research and development of crucial, life-changing drugs.

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New Dimensions of Clinical Trial Optimization

Article | April 20, 2021

For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea of the optimized clinical trial has centered on optimal patient samples, target enrollment rates, and generally the most efficient uses of scarce resources in the form of patients. Yet anyone who has had to design and optimize a clinical trial, knows that trial optimization occurs within an ecosystem of choices; a series of choices that stretch from the time it takes to implement a clinical trial and submit clinical data for analysis, to general concerns about the cost and power of a clinical trial. A true clinical trial optimization process would try to unify a number of these choices into a single framework for trial optimization. The complexity of clinical trial optimization comes from the need to align priorities on the one hand, and to understand opportunities on the other. We know that at a very general level, clinical operations specialists benefit from simplicity in clinical trial design, and that commercial teams prefer shorter clinical trials to longer ones. We also know that the statistical design of a clinical trial can influence both simplicity and duration. Yet how many sponsors have their clinical operations and commercial teams, sit with their R&D teams to review various statistically nuanced design options? For many sponsors, the reason this process does not occur as often as it should, is because the nuanced statistical parameters of a clinical trial design are very difficult to communicate to non-statisticians. Yet a trial optimization tool like Solara, equipped with data visualizations and the ability to see tradeoffs intuitively, can overcome this challenge. The real challenge is often convincing the non-statistician that they have a stake in clinical trial design. Cytel recently had a client that thought it needed a sample size re-estimation design, because it had a very strict limit on the number of patients it could enroll. After a few hours of working with Solara, though, a statistician discovered that a much simpler Group Sequential Design would deliver comparable power using about the same number of patients. The gains from the more complex design were minimal from the optimization perspective, when understood as the eco-system of choices. Similarly, most commercial teams pressure their clinical trial designers to have the most accelerated clinical trial imaginable, but as we all know, the longer the clinical trial the more likely there will be a higher number of events that demonstrate the effectiveness of a new medicine. So commercialization teams have a stake in longer clinical trials, even when their rule of thumb is to shorten them. Therefore, it is absolutely essential to communicate the benefits of various statistical designs to multiple stakeholders in a way that makes tradeoffs clear. Aligning on priorities early during the clinical trial design process is essential to selecting the optimal clinical trial. Yet for this statisticians need to be equipped for both a strategic and communicative role in the R&D process.

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Five Ways to Manage Your Trial Effectively in a Fast-Changing Global Environment

Article | March 11, 2020

Over the past half-century, clinical trials have grown increasingly complex. A flood of new data from novel sources combined with more elaborate study designs and tougher regulatory standards have lengthened timelines and hiked costs, contributing to a steady decline of efficiency. It all adds up: Nearly half of all drug launches underperform revenue expectations. And if that isn’t enough, the outbreak of COVID-19 worldwide is having an effect on how life sciences companies operate their businesses, including how clinical trials are conducted. Most clinical trial research organizations have tried to adapt by tweaking a platform here, adding a new app there, but this has only yielded patchwork systems of sites, spreadsheets and dashboards that further burden the process.

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Spotlight

DHelix Group

Double Helix thrives on unravelling complex challenges to create solutions that make a difference in healthcare. We are a team of trusted advisors who help our clients make the right strategic decisions. We do this through two strands: Discovery and Consulting.

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