Executing a Successful Clinical Trial - Requirements and Trend analysis

Navi Mumbai, India (PressExposure) March 06, 2009 -- Executing a successful clinical trial requires seamless communication and coordination among many stakeholders–study sponsors, contract research organizations, academic research organizations, site management organizations, patient recruiters, clinical investigators and patients.

Research shows that there is much room for improvement. The average Phase 1, 2, and 3 trials exceed their timelines by 20%. Delays in the clinical trial process cost pharma companies hundreds of thousands—even millions—in sales. Today, companies also encounter formidable challenges in the clinical development process, including the FDA’s increased involvement.

Streamlining Clinical Trials ([http://www.bharatbook.com/Market-Research-Reports/Streamlining-Clinical-Trials.html]) is the authoritative tool for clinical operations teams to accelerate their trials. This comprehensive guide delves into the latest industry trends and strategies for elevating efficiency. It focuses on resource allocation, performance measurement, continuous process improvement, patient and investigator recruitment and adaptive trial designs. Through extensive benchmarking data, real-company case studies and interviews with industry experts, the report shows how companies are moving their product candidates through development faster and more efficiently.

Use the report to:

Benchmark your clinical operations against leading companies Clarify performance objectives Identify and eliminate common trial bottlenecks Drive successful patient recruitment campaigns Plan study design and protocol effectively Discover and apply innovative patient and investigator retention strategies Weigh the pros and cons of adaptive trial designs versus traditional trials

Metrics Included in the Report Budget Metrics: Average per-patient clinical trial costs in the US by therapeutic area by development phase (Phase 1, Phase 2, Phase 3 and Phase 4) Percentage of clinical development budgets outsourced for US-based trials by therapeutic area by development phase (Phase 1, Phase 2, Phase 3 and Phase 4) Cost savings of clinical trials in India Comparisons to previous data (2006)

Staffing Metrics:

Trial-specific staffing for clinical trials covering about 10 therapeutic areas: Trial size and location(s) By development phase (Phase 1, Phase 2, Phase 3 and Phase 4) By the following clinical development functions and roles VPs and therapeutic area supervisors Trial managers CRAs/monitors Data management Medical writing Biostatistics/bioanalytics Regulatory Clinical quality assurance Clinical trial supplies CMC Contract management Drug safety Pharmacovigilance Percentage of in-house and outsourced staff By therapeutic area By development phase (Phase 1, Phase 2, Phase 3 and Phase 4) Patients per CRA By development phase (Phase 1, Phase 2, Phase 3 and Phase 4)

Performance Metrics:

Percentage of surveyed companies that track various performance measures for: Cycle times and time-based trial milestones Resource allocation-based metrics (budgets and staffing) Efficiency and operations-based measures Surveyed companies' assessments of metrics that have power to impact organizational change: Cycle times and time-based trial milestones Resource allocation-based metrics (budgets and staffing) Efficiency and operations-based measures

Other Metrics:

Factors impacting rising clinical development costs in the US (2008 vs. 2006 vs. 2004) Average number of patients per trial By therapeutic area By development phase (Phase 1, Phase 2 and Phase 3) Percentages of trials' time consumed by various trial activities Surveyed companies' rankings of opportunities for trial acceleration Surveyed companies' rankings of patient recruitment tools (e.g., search engine optimization) Surveyed companies' rankings of investigator recruitment tools Surveyed companies' rankings of investigator incentives

Adaptive Clinical Trials Design:

Percentage of companies performing adaptive trials design Surveyed companies’ ranking of adaptive clinical trials design versus traditional trials design Advantages and disadvantages of adaptive clinical trials design

Table of Contents :

Chapter 3: Continuous Process Improvement. The full report provides a comprehensive overview of several leading bottlenecks in the clinical development process, as well as forward-thinking strategies to eliminate them:

Issue #5: Increased Communication with FDA is Slowing Trial Design The FDA is now strongly recommending that companies meet with them in the early stages of trial development to make sure that their desires are met in the final product of trials. In particular, it is strongly recommended that teams meet with the FDA for the end of Phase 2, pre-NDA stage going into Phase 3 trials. Whereas in the past companies did a lot more at risk, now they wait to hear back from the agency and then have to incorporate changes that they the FDA wants.

One interviewee reveals that the FDA simply wants to make things easier for itself by having advanced knowledge of what is going to be in the final submission package. It also helps FDA officials ensure that what companies give them is the end as far as the submission and that the package has the information needed for a final decision.

ISSUE DESCRIPTION The increased back-and-forth between FDA and companies designing trials adds an additional step to the overall process and can slow trials tremendously.

INNOVATIVE SOLUTIONS AND RECOMMENDATIONS To combat communication slowdowns, many companies have begun concept designs and processes earlier. One company moved its process to 18 to 24 months in advance of when it used to. This allows sufficient time to communicate with the FDA…

Chapter 4, Recruiting and Retaining Patients and Investigators:

Help Investigators Market Trials Locally After giving investigators marketing tools in their recruitment kits, pharmaceutical firms help site investigators create a buzz in their communities about the trial. After all, a key to successful investigator-based recruiting is raising awareness in the local area around the study site. Pharmaceutical companies assist in several ways.

First, pharmaceutical firms encourage investigator sites to offer local seminars on available clinical studies. Here, patients learn of the study and raise concerns that are keeping them from enrolling. These meetings reduce patients’ fears about studies and allow investigators to explain the importance of the trials. To get the maximum benefit, pharmaceutical companies should send their CRAs to attend, and they can gauge the level of interest in each community and adjust recruitment efforts accordingly. These sessions also inform CRAs of potential patients’ issues that the protocol writers may not have anticipated.

Also key to success is building local advertising. With the materials provided in the recruitment kits distributed at the investigator meetings, individual sites market locally while maintaining the centralized message of the campaign. Larger investigator sites that run multiple trials often build their own websites advertising the trials they are running.

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Press Release Submitted On: March 06, 2009 at 1:37 am
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