'Investigator-Initiated Trials: Building Superior IIT Capabilities' Outlines Steps to Refine IIT Management Efforts.DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c87932) has announced the addition of Investigator-Initiated Trials: Building Superior IIT IIT - Integrated Information Technology Capabilities to their offering. Establish and perfect internal controls to capitalize on Cap´i`tal`ize on` v. t. 1. To turn (an opportunity) to one's advantage; to take advantage of (a situation); to profit from; as, to capitalize on an opponent's mistakes s>. IIT opportunities Investigator-initiated clinical trials (IITs) provide companies with the clinical data to further scientific understanding of their drugs. IIT findings help to expand on- and off-label usage, reach new patient populations, generate data for publication and solidify so·lid·i·fy v. so·lid·i·fied, so·lid·i·fy·ing, so·lid·i·fies v.tr. 1. To make solid, compact, or hard. 2. To make strong or united. v.intr. relationships with key opinion leaders. Once considered an afterthought af·ter·thought n. An idea, response, or explanation that occurs to one after an event or decision. afterthought Noun 1. , IITs are now often regarded as critical pieces of product development strategy. Reflecting this different mindset mind·set or mind-set n. 1. A fixed mental attitude or disposition that predetermines a person's responses to and interpretations of situations. 2. An inclination or a habit. , many companies have established centralized cen·tral·ize v. cen·tral·ized, cen·tral·iz·ing, cen·tral·iz·es v.tr. 1. To draw into or toward a center; consolidate. 2. IIT management groups and processes. While such efforts mark a giant step forward, all organizations still routinely confront challenges that range from slowdowns in the IIT-approval process to issues with trial oversight. Investigator-Initiated Trials addresses such obstacles and provides solutions by outlining steps to refine IIT management efforts. Use this report to accomplish the following goals: * Develop strategic thinking to align align (  līn),v to move the teeth into their proper positions to conform to the line of occlusion. IITs with corporate strategy * Compare timelines and best practices for IIT proposal evaluation and approval * Improve ongoing IIT oversight * Discover IIT management trends * Benchmark structures and investments * Examine profiles of 16 companies' IIT efforts Sample Content (The following is excerpted from Chapter 2, "Overview of the IIT Selection Process." The full report contains additional details regarding the processes by which companies collect, screen, review and approve IIT proposals.) Establish and Adhere to adhere to verb 1. follow, keep, maintain, respect, observe, be true, fulfil, obey, heed, keep to, abide by, be loyal, mind, be constant, be faithful 2. a Firm Set of Selection Criteria Virtually all of the surveyed companies use some form of a standardized standardized pertaining to data that have been submitted to standardization procedures. standardized morbidity rate see morbidity rate. standardized mortality rate see mortality rate. evaluation method to systematically identify viable proposals and reject infeasible ones. The criteria that review teams use to filter through study proposals are often based upon corporate strategic goals that are established by IIT management, as discussed in Chapter 1. Although selection criteria vary from one company to another, the foremost qualities that companies seek include: Strategic alignment: will the study help to accomplish the company's strategic objectives? Scientific merit: how valid is the study hypothesis? Originality o·rig·i·nal·i·ty n. pl. o·rig·i·nal·i·ties 1. The quality of being original. 2. The capacity to act or think independently. 3. Something original. Noun 1. : is the study concept a novel one? Feasibility: how achievable are the study's specific aims? Surveyed companies agree that strategic goals should play a role in the IIT selection process but recognize that translating those goals into a concrete set of standards is difficult. Some companies have made their selection criteria more specific in an effort to better match them with corporate strategies. An executive at Company F notes, "Worldwide we have put a more standardized infrastructure in place than we had a couple of years ago and added more detail and description to our SOP. We are putting more controls in place to make sure that the correct criteria are being compiled to ensure [strategic alignment]." Hold Frequent Review Meetings to Streamline the Evaluation Process Survey results speak loud and clear: the more frequently formal review committees meet, the more efficient they are at approving IIT proposals. Companies that hold weekly meetings achieve the most efficient process time of 11 days, on average, as Figure 2.13 [data charts appear in full report] illustrates. The relationship between meeting frequency and approval time is direct -- companies that hold biweekly bi·week·ly adj. 1. Happening every two weeks. 2. Happening twice a week; semiweekly. n. pl. bi·week·lies A publication issued every two weeks. adv. 1. Every two weeks. meetings achieve more efficient evaluation times than those that hold monthly meetings, and so on. Despite the apparent benefits of meeting weekly, 57% of examined companies hold monthly, rather than weekly or biweekly, review committee meetings to evaluate IIT candidates, as seen in Figure 2.14 [data charts appear in full report]... For more information visit http://www.researchandmarkets.com/reports/c87932 Source: Cutting Edge Information |
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