Trends to Watch in Early Clinical Trials
May 27,2015 Sarah Stapleton

The biopharmaceutical industry is an ever changing entity. It ebbs and flows as new technology and innovation carry it to new heights of precision for the evaluation of pharmaceutical products. Below are some trends in early development clinical trials we are experiencing here at Vince & Associates Clinical ResearchIf you are seeing additional trends we’d love to hear about them – leave us a comment at the bottom of this post.


Early Cardiac Safety Assessment Traditional TQT studies are conducted at an estimated cost of $2-$4 million dollars and usually during the later phase of clinical development, but there’s a new game in town. A recent study conducted collaboratively by the Cardiac Safety Research Consortium and the FDA demonstrated that new cardiac technology allows for QT assessment to be conducted as early as a First-in-Human clinical trial. This new methodology is a revolutionary concept in the industry and it enables pharma and biotech companies to evaluate their compounds earlier in development, get more precise data and potentially save millions of dollars if they can get a waiver for the traditional TQT study. Find out more…

Risk-Sharing Models Risk-sharing models mean exactly what you’d think they’d mean – the sharing of risk between the sponsor and the CRO. One example of this risk sharing model was launched in April by iCardiac Technologies. iCardiac’s program revolves around a guarantee to provide sponsors with precise, definitive data for Thorough QT studies or the sponsor pays nothing. Most models that involve risk-sharing center around things like milestones, budgets and data. The biopharmaceutical industry seems to be more open to the concept of risk sharing because of finite resources and changing pipelines. Find out more…

Driving Simulators In January of this year the FDA released a draft guidance entitled “Evaluating Drug Effects on the Ability to Operate a Motor Vehicle Guidance for Industry.” The guidance gives direction for evaluating drugs that have the potential to act on the central nervous system. Here’s what’s radical – this guidance proposes that all early phase clinical trials would have to evaluate cognitive function. So, how is cognitive function assessed? The answer is driving studies conducted on state-of-the-art driving simulators where the exposure-response relationship between drug concentrations and driving test endpoints can be evaluated. Find out more…

Abuse-Deterrent Formulations If you’ve been paying attention to the news then you know that the percentage of opioid abuse is on the rise at a frightening rate. While opioids can be effective when used properly, there is also a risk of misuse and abuse. The new FDA guidance was issued in April for abuse-deterrent opioids, “Abuse-Deterrent Opioids – Evaluation and Labeling,” explains and makes recommendations about abuse-deterrent drugs and how studies evaluating them should be performed. The guidance also discusses labeling claims for such drugs. This new guidance is a part of the FDA’s goal to “find the balance between appropriate access to opioids for patients with pain and the need to reduce opioid misues and abuse.” Find out more…

Patient-centric Study Design Clinical trials that are designed to be patient-centric are designed around positive experiences for the patients that result in higher retention rates. In patient-centric studies the patients are more than just the data that can be obtained from their participation. The treatment during the study strives to understand how the drug and disease affect the patient not just physically but also emotionally, socially and spiritually. Find out more…

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Welcome to VA Confidential, the official blog of Vince & Associates Clinical Research. Don't know us? In a few words, we are a premier clinical research site combining the power of physician-led study teams and the luxury atmosphere of our state-of-the-art, multi million-dollar clinical pharmacology unit.

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