Guide to Drug Development: A Comprehensive Review & Assessment by Bert Spilker offers comprehensive review of the principles and activities involved in developing new drugs, devices, and other medical products. The book covers many topics not discussed in any other textbook and includes timely discussions on electronic clinical trials, registries of clinical trials, data mining, computer simulations and modeling, and changing regulatory standards.
Each chapter includes practical tips, lessons, guides, firsthand stories, quotes from experts, and three to six questions for group discussion. The last three chapters present twelve case studies each on clinical trials, regulatory affairs, and management of drug development. It will be the standard reference text for everyone working on or studying drug discovery or development, in industry, academia, hospitals, government, and independent laboratories.
Representative excerpts from the text include trial design issues when the use of placebos is unethical.One of the reasons that using a placebo is unethical in some trials is that the IRB/EC wants to ensure that patients will not deteriorate physically. In this situation, it may be possible to inform the IRB that, if patients are randomized to placebo or active drug, then any patients who deteriorate when assessed at Day X will be dropped from the trial and given the standard therapy for their disease.
On the other hand, the issue may be that the IRB wants to go further and assure patients that they will improve and not simply remain stable. In this situation, the protocol can read that all patients will be assessed on Day X and any who have not improved by a predefined amount will be dropped from the trial. Both of these examples are referred to as fail-safe designs because anyone who fails to meet the standards at any clinic visit will be removed from the trial and placed on active therapy.
While where are some trials where additional sites are required to enroll more patients, it is often the last approach that should be considered because often there are other reasons for the lower-than-planned number of patients enrolled. This is mentioned because the author still hears from companies that want to add new sites to a trial as soon as they learn that recruitment is slower than desired, but they have not investigated the reasons for this situation. The primary principle is to identify the real cause(s) of the recruitment problem and to see whether the issue is the same at each site or varies from site to site.
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