Good clinical practice (GCP) guidelines govern important aspects of clinical trials to ensure patient safety and scientific integrity. “GCP” is a quality standard which refers to the document put forth by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH is a group made up of...
In general, greater certainty about the clinical benefit of a drug correlates with an increased time to achieve needed results — the best evidence can take years of careful follow-up. But an unnecessarily long time to market isn’t good for sponsors and patients alike. This is especially true for patients battling rare cancers: With many of these conditions lacking standard treatments,...
While adaptive design is associated with many potential benefits, it may also present challenges to observing the basic ethical principles of research in human subjects. In this white paper, we review the features of particular clinical trial design adaptations and discuss the ethical obstacles they can present and those they can potentially resolve. The value...
Traditional trials apply a frequentist strategy, which rely on the accuracy of pre-defined design assumptions (or inputs) to construct an effective design that yields robust final trial results. From first-patient-in to last- patient-out, trial execution proceeds without change, following a black box approach. While this strategy is common in clinical research, it is not well suited to...
What are sponsors in medical device trials responsible for? Pretty much everything. Seriously. Clinical trials for medical devices involve many complex “moving parts” in the form of different groups of investigators, suppliers, contractors, committees, and other organizations. For a successful trial, sponsors must make sure each works together in harmony. Roles of a Sponsor The seven key...
Clinical drug trials require enormous commitments of money and time, and sponsors are understandably motivated to ensure they’re run efficiently. Late patient enrollment, delayed site activation, and missteps during the course of the trial are just some occurrences that can raise the already high stakes in developing new therapies. So when we recently performed a...
No matter your role in the industry, you may have heard about the significant upcoming changes to European medical device regulations. But just what are they? What’s the proposed implementation timeline? Here’s an overview of the proposed legislation, as well as a tentative schedule of important dates. Getting Up to Speed In June 2016, the...
Rare diseases present some unique obstacles for researchers that significantly contribute to the high cost of drug development. Fortunately, innovations in biomarker use have the potential to significantly cut back on these costs while improving data quality. However, before biomarkers can be used in this research, their associated collection, measurement, and evaluation methods must be validated. The key phases of biomarker...
Joining in the elusive pursuit of fibromyalgia pain relief, a small pharmaceutical company engaged Premier Research for a Phase 3 trial following our completion of the product’s Phase 2 research. The compound under study: a muscle relaxer on the market for decades, repurposed for the possible treatment of fibromyalgia. The sponsor chose Premier Research largely...
In clinical drug research, time is of the essence. Not only are researchers, in many cases, trying to beat their competitors to market, their ability to conduct a timely clinical trial can be the difference between life and death for the target audience. The question is, then, how do you as a sponsor get your contract research organizations...