Balancing Phase II and III Efficacy Trials
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0092-861 5/98 Copyright 0 1998 Drug Information Associalion Inc.
BALANCING PHASE I1 AND I11 EFFICACY TRIALS BOBBYW. SANDAGE, JR., PHD Executive Vice President of Research & Development, Interneuron Pharmaceuticals, Inc., Lexington, Massachusetts
This paper compares the traditional drug development pathways with an innovative method for combining objectives and study designs within one trial. Evidence is offered in support of combining Phase II and Phase III trials for certain diseases and drugs. Newer regulations and guidelines are encouraging drug developers to be efficient and creative in conducting clinical trials. Key Words: Efficacy trials; Phase I1 and 111
THE TERMS PHASE IIa and Phase IIb are conclude with the regulatory and developspecific jargon invented by the pharmaceuti- ment issues. cal industry to refine the steps in the drug The cost of drug development and the development process. These terms do not time required has increased sevenfold since have any specific regulatory meaning but the 1970s, currently exceeding $350 million. they were invented to help people understand Much of this additional cost is the result of where a particular drug was in development. ever-changing regulations that the pharmaAnother recent addition to these terms is the ceutical industry must comply with, but some “Phase IVIII study.” The industry invented of the cost is the additional development cost or actually, more precisely, borrowed, this that comes from the cost of discovery reterm from the cancer development programs search. The amount of evidence required for of the late 1970s. Phase II/III uses the con- establishing safety and efficacy for the Food cept of combining the objectives of a Phase and Drug Administration (FDA) and other I1 and 111trial within a single trial. This paper regulatory authorities has also climbed. both will discuss the merits of such a designation. in the number of trials (doubled since 1980) This paper is arranged to present some required and the patients studied (increased well known facts about the pharmaceutical almost fourfold since 1980). Pharmaceutical business, discuss why clinical “phase inf la- companies are expected not only to study the tion” is needed in some development pro- target patients, but specific subpopulations grams, discuss why combining trial designs and different groups, such as children. Now, is important, compare Phase I1 trials with all this may be necessary, but some of it may Phase 111 and describe combined trials, and not. In either case, this adds up to more trials per new drug application (NDA). Besides the needs for regulatory authoriPresented at the DIA Workshop “Improving Clinical ties to have more assurances before approval, Trials, Contemporary Design Solutions,” October 27the pharmaceutical industry has decided that 28, 1997. it is a competitive advantage in many cases Reprint address: Bobby W. Sandage, Jr.. PhD, Into have bigger studies than the competitor terneuron Pharmaceuticals, Inc., 99 Hayden Ave., Lexington, MA 02421. and thus have produced
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