A decade of Clinical Trials

My colleague and then Society for Clinical Trials (SCT) board member Kay Dickersin called me in spring of 2003 to ask a favor: would I consider taking on the editorship of the society journal, Controlled Clinical Trials? I protested vigorously; too much time, I said, not enough help, no support, I had papers to write, etc, etc. All true, but I knew I would say yes. Editing had long been in my blood, and to be able to continue the strong journal tradition established by Curt Meinert, the founding editor, Janet Wittes and then Jim Neaton was too tempting. Now, 10 years and over 660 published articles later, I am glad I did. But had I known then what I was about to face, I might have demurred. Why? The society was in negotiation with the publisher Elsevier to renew the journal contract. A decision was soon to be made – with my concurrence – that we should jump ship. This meant that I was not about to take over Controlled Clinical Trials, but rather a new journal with a new name, no Medline listing, no impact factor, no institutional subscriptions, no articles in the queue, no staff, little money, and an empty Excel spreadsheet to manage articles that would somehow appear from somewhere. What we did have was a dedicated editorial board – all of whom moved to the new journal – and a society membership that provided the initial subscriber base and source of articles. Looking at the contents of the first issue, one sees what that meant: a lively and eclectic collection of articles and commentaries that still inform and entertain, every one written by someone in the SCT or a colleague. There was a mix of methodology; one on dynamic treatment regimens by Lavori and Dawson [1], three on data monitoring committees, two from the DAMOCLES group (Data Monitoring Committees: Lessons, Ethics, Statistics) [2–4], a delightful retrospective and accompanying editorial on the Salk polio vaccine trial [5,6], and a very nice article on the groundbreaking model of ‘coverage under evidence development’ embodied by the National Emphysema Treatment Trial [7], followed by four terrific commentaries. But my favorite, 10 years later, was a profile of a founding SCT member, Paul Meier [8], by my colleague and erstwhile associate editor Harry Marks [9], neither of whom survived the ensuing decade. That interview, which I commend to all readers who missed it, was a tribute to both Paul and Harry’s wide-ranging scholarship, knowledge, and humanity, and provided rich material for Paul’s obituaries after his death in 2011. That first issue was a harbinger of a decade spent exploring in the journal the multifaceted nature and the scholarship around the methods of human experimentation, which encompasses the fields of statistics, medicine, biology, ethics, epidemiology, economics, history, law, policy, sociology, study design, inference, philosophy, informatics, and yet other fields, with a soupcon of passion. It is hard not to enjoy playing in that sandbox. But as I was warned by a sage colleague at the time, it is not the inaugural issue that tries editors’ souls, but the second one. And so it was. This forced me to contemplate some existential questions, like ‘What is the minimum number of articles that can legitimately be considered a journal ‘‘issue?’’’. The answer had a surprisingly concrete foundation; the number of pages whose thickness was sufficient to fit the words Clinical Trials on the spine of the bound journal. That turned out to be about five articles, the precise number comprising the second issue, and several thereafter. I confess this led to occasional musing about the joys of heavier gauge paper. A medical editor colleague, puzzled when I told him I was taking on this job, asked what there was left to learn about clinical trials. The 600+ articles published since then in this journal represent just a first chapter of an answer. Amazingly, the need to develop further the theory and application of randomized clinical trials is now a pressing national priority. With health-care costs crushing the nation’s economy without concomitant return, and a clinical trial model involving the creation of a parallel care system that is similarly unsustainable,