Premier Perspectives Blog

Insider Insights in Clinical Development

Translational research has the potential to help all patients, but the principles behind bench-to-bedside research hold special promise for patients with rare diseases — many of which have no standard treatments. Here’s how changes to the way rare oncology studies are performed are getting treatments to the patients who need them at a faster rate. What MakesRead more

In December 2016, the United States passed an important piece of regulatory legislation called the 21st Century Cures Act. These FDA regulations cover multiple types of clinical research but include some specific provisions for medical device development. In contrast to the regulatory reform seen in the EU — which includes a much-needed increased emphasis onRead more

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 regulatory officialsRead more

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,Read more

Traditional trial design use only a priori inputs to obtain final trial results. From first patient in to last patient out, trial execution proceeds without change, following a black box approach. While a standard for clinical research, this strategy doesn’t always suit rare oncology research, which must contend with very small patient populations that are often difficult to treat.Read more

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 keyRead more

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, theRead more

Despite advances in the orphan drug development process and the more prominent role that patient advocacy groups now play, researchers in this area still face a number of challenges. But, fortunately, increased collaboration between patient groups, industry leaders, and regulatory bodies can help overcome these hurdles. Barriers to orphan drug research include: Small population By definition,Read more

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 biomarkerRead more

With increasing demands for evidence of clinical efficacy and safety, applying sound research practices to medical device development is crucial for a product’s success. The Need for High Standards in Study Design When bringing a new medical device to the market — or even reevaluating an existing product — device companies must answer to: Regulators placing greater scrutiny onRead more

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 organizationsRead more

One of the most rewarding efforts I’ve seen in my years working with Premier Research is watching our Rare Disease Day activities unfold. Every year we ask our employees to support Rare Disease Day in some way, so we can all remember how crucial our role is in clinical development, especially in this area ofRead more

Phone Us Now
Email Us Now