This is the fifteenth and final installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Read the rest of the posts in the series here. As our Placebo Problem series draws to a close, we conclude by taking a brief look at three ethical issues...
Quality Agreements are an effective bridge to a successful future for companies in the drug development sector – putting one in place at the start of the business relationship can prevent problems later. Quality Agreements mitigate risk and increase collaboration between partners. These agreements define timelines and establish responsibility and accountability. They supplement contractual commitments....
The use of Clinical Endpoint Committees for centralized adjudication of efficacy and/or safety endpoints can help to standardize outcomes and optimize the quality of clinical trial data, driving study success. Some compounds and many devices face the challenge of defining efficacy or safety endpoints so that they are scientifically measurable, objective, and valid. Often, clinical...
For a Clinical Endpoint Committee (CEC) to make important decisions, it needs the data to do so. That’s why developing an effective and reliable endpoint data capture strategy is a vital part of working with a CEC. Before starting a clinical trial, sponsors should be able to answer these questions. 1. What needs to be defined?...
In our previous CECs blogpost, we reviewed why Clinical Endpoint Committees (CECs) are so crucial for successful trials today. But just how do sponsors establish and operate a CEC? It’s a complex process that can be broken down into these eight key steps: 1. Understand the deep level of commitment required in putting a CEC together....
DURHAM, N.C., June 19, 2017 — Data integrity has been a prime focus of pharmaceutical regulators for two decades now, but the focus is sharpening markedly with issuance of new guidance from multiple regulatory authorities. Sherri Hubby, who leads quality assurance, risk, and compliance at Premier Research, will address this trend and its implications at...
Sponsors often face significant challenges in collecting robust, quality data that demonstrates the safety and efficacy of investigative psychiatric drugs. However, before these problems can be solved, they must be understood. Be sure to keep these four issues in mind when mapping out strategies for ensuring quality data collection in psychiatric clinical trials. 1. There...
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 on...
When applied to clinical development, Quality by Design is an approach that focuses effort on prospectively identifying and managing risk to improve clinical trial quality and outcomes. The application of Quality by Design principles is particularly important in rare diseases, where the limited, geographically-dispersed, and often vulnerable patient pool leaves little margin for error. By...
Sponsors of psychiatric clinical trials may face significant challenges in collecting robust, quality data to support the efficacy and safety of investigative compounds. Identifying and mitigating study design-, subject-, and site-related factors that may influence data quality as early as possible in program development can help to drive study success. Ensuring that psychiatric clinical trial...