The Time for Resolve
Sometimes a new year requires a new approach
For several years, I subscribed to the belief that making New Years resolutions was simply a setup for failure. That may have been based on the number of times I resolved to quit smoking before I actually succeeded. All my experience with an academic calendar was probably an additional influence. Not only did I have children on that calendar for many years, I also worked at a university and attended a community college and two universitiesall of which made September the de facto New Year for much of my adult life.
As 2002 drew to a close, evidence kept piling up that led me to believe that I needed to at least plan for some new approaches in 2003. It took only one small step to move from a plan to resolutions.
Resolved: Seek readers counsel
For one thing, so many of you sent good ideas in response to my December editorial about subject recruitment that I resolved to seek your counsel more often. In fact, Ill start right now by asking you to tell me what you would most like to read about in 2003 issues of Applied Clinical Trials.
What do you see as your most urgent information needs in the year ahead? In an industry that experiences so many changes so often, my months away from the magazine and subsequent part-time work have left me wondering whether Im fully in touch with the hottest issues facing readers today.
Have the high-profile lawsuits against some clinical research sites affected the way you recruit subjects? Have they changed your consent processes?
Have downward changes in the economy changed your business practices? For example, do you do more or less outsourcing? Has your workplace experienced layoffs or hiring freezes?
Resolved: Faster turnaround
Ive also resolved to respond to queries from readers and potential authors more speedily. Although our Information for Authors specifies, Within 510 working days after receiving a manuscript, Applied Clinical Trials notifies the author of its receipt, I plan to do better that that. The 10 working days limit allows for poor Internet connections when traveling, but 3 or 4 days is my goal when Im in the office.
Resolved: Walk on left facing traffic
Even when walking on the sidewalk these days, I observe that rural custom. Its a good way to see whats coming and what just might run into you and knock you down. Its a good way to prevent an unexpected trip to a hospital.
Have a happy and safe New Year everyone.
Jane GanterEditor-in-Chief
phone: (541) 984-5251
email:jganter@advanstar.com
Guidelines for Obtaining Informed Consent for Clinical Research
November 2nd 2003Informed consent is a process, not just a form signed by prospective study subjects. Documents such as the Code of Federal Regulations describe the elements of informed consent, but lack substantive direction on the process of obtaining consent.1-2 The purpose of this article is to provide guidelines for obtaining informed consent. This guide can be useful to anyone involved in clinical research, particularly newcomers to the industry.
A Clinical Development Solution Tailored for Biopharmaceutical Companies
November 1st 2003The rapid evolution of the biopharmaceutical industry has lead more and more companies to focus on the clinical development of their drug candidates, thus presenting the challenge of selecting the optimal strategy for conducting their clinical programs. Typically, biopharmaceutical companies have had three options: out-licensing their product, setting up their own clinical development operations, or outsourcing the clinical development to contract research organizations (CROs).
