Paul Bleicher MD, PhD, is the founder and chairman of Phase Forward, 880 Winter Street, Waltham, MA 02451, (888) 703-1122,
paul.bleicher@phaseforward.com, www.phaseforward.com. He is a member of the Applied Clinical Trials Editorial Advisory Board.
|
With the new year upon us, this column would like to to look back at the past one to review some of the important trends.
In fact, the past year was a tipping point in the adoption of electronic technology in clinical trials. The industry has been
on an accelerated path of adoption of electronic data capture (EDC) for several years, but I believe that we will look back
on 2007 as the year in which the most significant changes in attitudes and adoption occurred.
But rather than focus on the recent past or near term, I would like to paint a picture of clinical development as it might
be at some distant future point, enabled by technology and fashioned by a variety of current and future pressures. I know
some of you will tell me that I wrote a column back in October on The Black Swan that discussed the impossibility of prediction. I freely admit that I am not a futurologist and I do not expect this world
to ever come about just as I describe it in the following paragraphs. In fact, these ideas are somewhat of a reductio ad absurdum: an extreme extension that would likely be limited by the slow pace in pharma and other factors. The future we all will likely
experience will probably be much closer to the present than what I am about to describe.
The horse before the cart
The process of drug development and drug approval is under pressure from a variety of different and sometimes contradictory
forces. The forces of change that are most relevant to this discussion are drug safety, access to new medicines, and the costs
of developing new medicines. The one with the most potential to create substantial change in the approval process is drug
safety. We are currently in a cycle where concerns over public safety are at the forefront of public and regulatory discussion. In
the United States, several major pharmaceutical companies have been under attack financially for safety issues in widely prescribed
medicines. The public is not sufficiently educated in the meaning of risk and benefit in prescription drugs to understand
safety issues in perspective and demands safer drugs through lawsuits and legislation.
Unfortunately, it is quite evident that the clinical trial process today is insufficient to identify, characterize, and calculate
all of the safety issues in a new medication. The number of patients studied in a typical NDA is too few to identify serious
adverse experiences, let alone demonstrate whether they are statistically associated with the drug. In addition, reliance
on spontaneous and literature reporting of adverse experiences is flawed and not adequate alone for safety surveillance. The
current trend is to examine such safety issues, and even risk/benefit considerations, through careful monitoring of patients
postapproval through longitudinal analyses and registries.
On the completely opposite end of the spectrum, the public also consistently demands and hopes for the development of new,
life-saving drugs for serious conditions. These demands are intensified as new health threats emerge. Of course, anyone reading
this column is well aware of the tremendous costs for identifying and testing a new therapeutic agent. This is compounded
by the trend to narrower indications and more "personalized" medicines.
Meanwhile, on the technology front, in parallel with the emergence of EDC, we are witnessing a similar adoption of technologies
for the delivery and monitoring of medical care. However, the adoption curve may well be different for such technologies,
as the economic pressures and value achieved by these technologies aren't necessarily apparent to those who might pay for
them. The technologies that are most relevant to my argument are universal access to the Internet and cell phones, electronic
health records (EHR), and personalized home monitoring.
Universal access to the Internet is arriving rapidly in the developed world. While not every family has a computer in their
home, most have free access through public libraries, at least in the United States. This access will make many things possible,
including the monitoring of individual patient experiences with drug therapies.
