Clinical Trials Articles

For truly informed consent, methods should gauge a subject's real grasp of a clinical trial's complexities. The concept of informed consent has evolved over the past century. More than just a document, informed consent (IC) has been acknowledged as a process. It conveys information to the potential subjects with—ideally—active discourse between the subject and principal investigator or designee in order to obtain the potential subject's agreement to participate in a clinical trial. But once the form is signed, indicating IC was obtained, can the study team truly assert that the subject has an adequate grasp of the complexities participation in a clinical trial entails?

Paying attention to key performance metrics will eventually reduce global clinical development times and deliver innovative treatments earlier.

The head of your company's clinical development department requests you to draft a project plan for a multinational Phase III trial of 800 asthma subjects within three weeks. This plan should be quite specific regarding the number of countries and study sites involved, the subject recruitment period, and the expected total cost of monitoring visits. You are in a considerable dilemma. You have been opposed to implementing a proper performance metrics system. What tools should you now use? Memory? Intuition? Best guesses? Will the development head be impressed with you at the conclusion of your project, should this ever happen, if time and money spent exceeds your plan by as much as 100%? 

Making good decisions as early as possible and building in flexibility are critical.

There are many issues that clinical project managers need to address during the course of running a clinical trial. One issue that is mostly outside of their remit, and which many may feel relatively powerless to influence, is the supply chain for investigational medicinal products (IMPs).

 The manufacture and packaging of medicines for use in clinical trials can appear, on the face of it, a fairly straightforward exercise. In reality, it may be a complex logistical challenge which is often grossly underestimated. This is true worldwide, although the issues are compounded for multinational studies. Recent legislation in the EU has added yet more hurdles to overcome.

This article will review the current regulatory framework as well as the process for supplying IMPs, and then consider possible options that may improve the supply chain.

Informed consent takes place in the brain. While that seems obvious, the implications of that statement go much deeper.

To a great extent, both bioethics and federal policy are based on 17th century assumptions by philosophers such as Descartes—who knew nothing of the structure and function of the brain. In his 1994 book Descartes' Error: Emotion, Reasoning and the Human Brain,

 neurologist Antonio Damasio argues that reasoning is not merely an abstract philosophical concept, but primarily a biological function of the brain. Despite Descartes' widely accepted separation of mind and body—with its implications for the superiority of reason over emotion—Damasio uses data from brain-damaged patients to show how and why Descartes' mind-body separation is wrong.

Emotion and reason in the brain

Potential solution to an industry challenged by skyrocketing R

According to a recent 2003 Impact Report by Tufts Center for the Study of Drug Development, pharmaceutical companies now have an average total R&D cost of $802 million per new drug entity and $897 million, if both pre-and postapproval phases are included.1 Pharmaceutical companies must initiate their clinical trials in an increasingly efficient manner to ensure thorough protocol development, prompt regulatory readiness, high quality, cost-effective study initiation training, accurate and efficient study supply delivery, steady enrollment, quality data collection, monitoring, reporting, timely issue resolution, datalocks, and study closeout. All of these functions must be done within a set budget and timeline.

A business case for building the integrated clinical data warehouse

Drug and medical device developers face an important fork in the road concerning data management for clinical trials. For years they have dropped information gathered by case report forms (CRFs) into data "silos"—database applications designed for one trial only. Their focus has been strictly on completing the trial's analysis so they can submit their new products for FDA approval as quickly as possible. There has been little concern for the future usefulness of the raw data.

Understanding when medical care crosses an unmarked border into clinical research is an important aspect of patient protection and regulatory compliance.

Medicine and clinical trials--time for a paradigm shift?

The pharmaceutical industry is under siege again with the recent discovery of high cardiac risk and the use of COX-2 inhibitors. The authors of a New York Times story noted that exposure of these drug risks was the "clearest instance yet of how medicine and marketing can turn hope into hype" (12/19/04).

 At a time when profits in the pharmaceutical industry are down, generic drugs are gaining ground, drug importation is looming, and blockbuster drugs are on a downward spiral, the industry needs to take a step back and weigh the consequences of the loss of public confidence. Perhaps it is time for a paradigm shift in the way the science of drug discovery is communicated.

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To say that the guidance does not cite any references to support its views is an irrelevant argument.

 Since the publication of a guest commentary by Marc Buyse and Damian McEntegart, ACT, May 2004, we have received several Letters to the Editor. We feel we owe the authors of the following commentary and response more than a Letter to the Editor status, as they were prominently involved in the regulatory guidance. All three authors were involved in drafting The Points to Consider document. -

-The Editors

We read with interest the article by Marc Buyse and Damien McEntegart (ACT, May 2004, pp. 36-40). To try to achieve a more balanced discussion of the recent European regulatory guidance in question, we would like to comment on several of the points that they raised.

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Pharmaceutical companies need to integrate pediatric assessments into the standard drug development process and build up pediatric competence.