Columns | A Closing Thought

It's out with the old, in with the new for clinical development.

With its vast pool of patients and well-trained, English-speaking investigators, what exists to take advantage of in this research-rich country is clear. What needs to be given back, however, is not so clear. Despite the uncertainty, one thing seems evident: Responsibility is key to giving back.

While not a panacea, pharmacogenomics is still a valuable trial tool that can make the recruitment process more efficient and eliminate the high costs associated with late-stage product failure.

India continues to gain the attention of pharmaceutical companies looking for a place to conduct clinical trials because of the country's reputation for fast subject recruitment rates. But as Jane Barrett reveals, sometimes the country's clinical trial participants are more uninformed than informed.

There are a number of factors potential subjects need to consider when deciding whether to participate in a clinical trial, including an often overlooked matter that this month's authors examine: taxes.

A discussion of the recent initiatives for applying advanced technologies in real world settings that have the capability to improve drug research, increase subject safety, and reduce development costs, which takes into account the collaborative efforts among government, academia, industry, and patient groups that are necessary to achieve these goals and translate new technological discoveries into clinical practice.

A patient's agreement to take part in a clinical trial is a legal contract, which consumer law requires to be expressed in plain language.

Right now the industry has a chance to reclaim its good name and recapture the public's respect for the power of what it can do.

Rethinking the current pharmaceutical model

A growing number of sponsors and regulators are recognizing that accredited organizations are more likely to be compliant.

Personal integrity is what we need to insist on as the finality of good clinical practice.

Today's technology makes significant improvements in trial safety systems possible.

Closing Thoughts on the state of clinical trials in India today.

Despite requirements for consent forms at lower grade levels, evaluation studies find little or no improvement in understanding.

Making important data more consistent and more accessible has the potential to improve safety and efficacy.

Thoughtful application of eDiaries can make clinical development much more efficient.

The FDA Initiative represents the challenge facing our industry.

The clinical trial industry can thrive by offering easy-to-use technology to make data available earlier.

Even with current trial management systems, steps can be taken right now to greatly increase efficiency.

As laudable as it may appear to be, the Critical Path Initiative will create as many problems as it solves.

Much has been written about the staggering costs of drug development and how the low Phase III success rates across the pharma industry have contributed to these costs. While safety outcomes explain many failures during the early development phase and have likewise played a prominent role in some highly publicized product withdrawals, efficacy failures in Phase III have received little attention. What we now know, however, is that a significant number of Phase III failures are attributable neither to issues of safety nor product differentiation, but to an inability to confirm efficacy against placebo.

The Food and Drug Administration's (FDA) Critical Path Initiative and subsequent guidance documents have sparked the revitalization of the life sciences industry.

FDA's Critical Path Initiative is an excellent idea, but is the time right?

Ambitious in scale and scope, the Critical Path Initiative provides a rational construct for framing the central paradox of today's new drug and new device development industry.

The Critical Path Initiative (CPI), as it has come to be called, provided the FDA's analysis of the current drug development pipeline problem, characterized by a recent slowdown-instead of the expected acceleration-in innovative medical therapies reaching patients.

In March 2004, FDA issued a provocative white paper: Innovation and Stagnation-Challenge and Opportunity on the Critical Path to New Medical Products. The Critical Path was identified by FDA as those parts of the R&D continuum that constitute bottlenecks in the drug development process.

Scientific discovery is, by its very nature, plagued by a lag between concept development and the acquisition of the tools necessary to fully explore a new technology's application.

When the FDA stated that "the applied sciences needed for medical product development have not kept pace with the tremendous advances in the basic sciences" everyone seemed to agree.

Following the model of the home health care industry might be the answer to high subject dropout rates in clinical trials.

Clinical departments are very expensive to run and maintain.