Jane Ganter is currently Editor Emeritus of 

Jane Ganter

 get to be 20 years old already? Twenty years ago I thought 30 miles was a nice leisurely after-work bike ride, and I was still two years away from having the grandson who starts college this fall. 

My immersion in clinical research, informed consent, and the protection of human subjects began in 1974, when I worked in a university clinical psychology program. A decade later, I became associate editor of 

 In 1984, the Orphan Drug Act was still news and most trials were conducted in academic medical centers, though other trials centers were being introduced and discussed. CROs were in their infancy and often viewed with some suspicion. 

Two landmark events for clinical research occurred between my time on 

 and moving into the editor’s chair for 

. In June 1989, during the first month of my tenure on 

 newspaper box that boded well for the future of the biotechnology sector: Amgen had received marketing approval for epogen. In 1992, Congress enacted the Prescription Drug User Fee Act (PDUFA) to speed reviews for marketing approval. 

Twenty years ago I was editor of one of the company’s plastics magazines. That is related to my tenure on 

. At a manufacturer’s event, each of us received a plastic replica of the chimpanzee sculpture commissioned for the speaker. The founding editor of 

 Jennifer Lindsey, had spent a leave of absence working for that speaker in Africa. When I gave Jennifer the replica, I had no idea she was about to resign from 

 to work for the Jane Goodall Institute. I remember telling her it was only a plastic replica; she didn’t have to give up her job for me.

At my first ACT conference, in September 1994, I met Ken Getz, who had recently launched a little newsletter called 

. It was successful, and so was another person I met there: 

’s soon-to-be publisher, Wayne Blow. What a fantastic leader — and friend — he became.

Back then, regulatory submissions were still on paper—truckloads of paper. When FDA first started accepting digital submissions, every company had its own platform and database. FDA reviewers could have two or three or more computers installed in their cubicles and would pick their way through various programs to review marketing approval submissions.

From my perspective—not surprising in a family of editors—language changes have been a Big Deal. In the mid-1990s, industry professionals used a wide variety of terms for the same concepts. At one point we compiled a list of 20-odd job titles for clinical coordinators. That was probably my main motivation for creating 

’s first clinical trials glossary. Similarly, CDISC set out to establish consistency in digital submissions language. We combined forces a few years later. Even during the first three or four years of my alleged retirement, I continued to work with the CDISC glossary project team.

, I had short professional attention span. In three or four years, I was looking for a new challenge. With something new happening every day in clinical research, I had no need to look further for an opportunity to fulfill my obligation to learn something new every day. Because I last attended DIA and ACRP meetings in 2007, I have surely missed many learning opportunities in the past five years. 

But, as the old saying goes: The more things change, the more they stay the same. It seems safe to assume that one thing hasn’t changed: the clinical research community’s never-ending quest for ways to make the development process more efficient and effective and better ways to recruit and retain subjects. 

Articles

Jane Ganter: A Look Back at ACT

During the quarter-century since my introduction to pharmaceutical research, I have been repeatedly reminded that the industry doesn't stand still. Working with the authors on 

second Trends in Subject Recruitment insert showed it once again. During my "retirement," I continue to work with clinical research professionals. Not one of them has ever suggested that the industry has everything figured out. No one has ever told me, "Now, at last, we can just cruise along without innovating."  

Recruitment specialists are no exception. They look at the previous year's successes and see springboards to new approaches. They know that a clinical trial delay is extremely costly. Speedy enrollment of the specified number of subjects required by a protocol's inclusion criteria is critical. Retaining those subjects throughout the study can make the difference between losing out to a competitor and launching a profitable new product. 

Industry lore has long included wry jokes about the disconnect between an investigator site's optimistic projections and that site's eventual enrollment. But you never hear anyone chuckle about the problems involved in rescue operations. 

Each recruitment consultant has a different way of tackling the issue. Despite subtle—and not so subtle—differences in approach, they all seem to see the same key to success: accurately predicting site performance. Although that key is often elusive, specialists glimpse it often enough to feel hopeful. They continue to refine their search methods. This year's Trends in Subject Recruitment contains reports of improvements on last year's successes. Everyone continues to strive for better methods, more accurate predictions, better data analyses. 

It's no wonder, then, that I remain fascinated by the whole clinical research enterprise. When the editor of sister publication 

interviewed me for the associate editor position, I warned her, "I have about a three-year attention span." I had been a corporate editor for Colonial Williamsburg, a radio and television advertising copywriter, a radio news reporter, a university administrative assistant, a psychology research clinic administrator. Each held my interest for two to five years. Some of those positions were absolutely captivating—for three or four years. 

Then along came pharmaceutical clinical trials. Never once during nearly 10 years with 

did I think, "This is getting repetitive and dull, time to move on." Never once during more than six years as a freelancer have I seen any sign that clinical research professionals are ready to rest on their laurels. 

The articles that follow note the need for the general population to be made more aware of clinical trials. That seems logical. Those of us who are intimately involved hear so much about it that it can be easy to assume that the rest of the populace hears it too. So strategic marketing is an important component, marketing informed by the analysis of many kinds of data from a variety of sources. 

This insert is packed with innovative ideas about effective subject recruitment. I can hardly wait to see what the next step of innovations will spring from this year's accomplishments. 

a freelance editor and writing coach, retired as Editor Emeritus of 

No one involved in clinical research is ever quite satisfied with the status quo.

Recruiters Always Strive to Improve

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.


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 

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?


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, 

 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.


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.

Editor-in-Chief
phone: (541) 984-5251
email:

Sometimes a new year requires a new approach

The Time for Resolve

Kenneth Getz and Deborah Borfitz, CenterWatch (Boston, MA, 2002) 306 pp., $16.95.

When potential subjects start reading this book, investigators and study coordinators will hear questions theyve never been asked before. To be prepared for informed patients, every clinical research professional should read this Consumers Guide to the Risks and Benefits of Volunteering for Clinical Trials.

Research sites will surely gain a competitive advantage when recruiting subjects if they can satisfy these well-informed volunteers with clear answers to their questionsand subjects who have studied this book carefully will have a great many of them.

Chapter 3, Doing Your Homework, provides dozens of questions that potential subjects can ask as they, their families, and friends play the role of dogged detectives to determine whether particular trials are right for them. 

Questions range from the scientific (what phase is the study?) to the professional (are check-in procedures private and confidential?) and from the medical (finding out everything possible about the disease or condition) to the logistical (how far away is the research site?).

Getz and Borfitz sugarcoat nothing as they describe and explain clinical trials. They set their tone early with a frank and clear description of the difference between experimental treatment and regular medical care:

It is a common misconception that receiving treatment in a clinical trial is the same as receiving treatment as a patient. The hard reality about a clinical trial is that it is designed to answer a scientific question, not to provide medical treatment. . . . When youre a research subject, you often feel like a patient. You usually make visits to a doctors office where youre examined by a doctor, undergo lab tests and receive a medication. In many ways participating in a clinical trial seems just like visiting with your doctor to receive medical care. But your doctors primary goal is to help you feel better. The principal investigators primary goal is to see how you will react to a new drug in order to determine whether that drug will be medically useful.

Readers who have studied chapters 2 and 3and have done their homework thoroughlymay even ask questions to which they are listening for specific answers, because near the end of chapter 2, the authors explain that 

The research center isnt the onlyand may not even be the bestsource of information about a particular clinical trial. Research centers recommend specific clinical trials for a variety of reasonsscientific, political and even economic factors are all influences. Some clinical trials bestow professional prestige and monetary rewards, for example, on researchers and research centers. Often these rewards may cloud otherwise sound medical decisions.

Chapter 4, Giving Your Informed Consent, explains a typical consent form section-by-section, with an emphasis on subjects rights and responsibilities. It includes five comprehensive checklists of suggested questions about the trial, care and treatment, personal and privacy matters, costs and compensation, and the research staff. These are not frivolous questions, and not all sites will have good answers to such queries as Why did the investigator decide to get involved in clinical research? or What sort of research training and certification have the investigator and coordinator had?

Chapter 5 outlines the history of human subject protection and Chapter 6 describes the special considerations involved in trials with vulnerable populations. Chapter 8, Finding Clinical Trials, provides step-by-step strategies for locating appropriate trials and includes a rich and current array of government and industry sources with Web addresses.

The book as a whole presents a well-balanced view of the clinical research, but Chapter 7 is particularly noteworthy for its explanation of the professionals and procedures in place to ensure that your rights are protected and that the risk of participation is minimized. In that chapter, titled What to Do When Things Go Wrong, concise bullet lists outline the responsibilities of sponsors, investigators, IRBs, and coordinators. Those lists are followed by detailed information about the organizations and agencies that can help when a subject has a complaint.

The book is a mixture of concrete advice that a reader can put into action and clear (though sometimes a bit academic for a lay reader) explanations of the underlying history and philosophy underlying the current regulations and guidelines to protect human subjects.

 is as a three-bookmark book. I read it on trains and planes with boarding passes to mark not only the page I was reading but also two appendixes: the glossary and the history of regulations. Once back in my office, I marked each appendix with a permanent tab for easy reference to the Glossary of Terms, History of Regulations Affecting Patient Protection in Clinical Research, the Declaration of Helsinki, the Belmont Report, 45 CFR 46, 21 CFR 50, Form 1572, the Directory of Health Associations, and the Directory of Biotechnology and Pharmaceutical Companies.

 editorial reference libraryand it belongs in every research center.

Patients who read this book and do their homework before consenting to participate in a clinical trial will give new depth and dimension to the concept of informed consent.