Examination of Clinical Trial Costs and Barriers for Drug Development. E.3.6 Drug Sponsor-Imposed Barriers

07/25/2014

  • Excessive risk-aversion leads to unnecessary steps being taken.
  • In multicenter trials, uncertainty and inconsistent enrollment success across sites creates a need to over-enroll and plan trials “defensively.”
  • Internal review processes for organizations conducting/sponsoring clinical trials can delay a trial’s start.
  • In trying to create a pure scientific experiment (to maximize likelihood of drug approval), sponsors may restrict enrollment using extensive eligibility criteria that may exclude, for example, people on other medications or with comorbidities. These constraints on enrollment make it even more difficult to find a sufficient number of participants and protract the recruiting process.
  • Industry sponsors generally do not involve site investigators in the protocol design process, so the required procedures may not be easily integrated into clinical practice at the sites.
  • Clinical trial protocols are increasingly complex (with more assessments, exploratory endpoints, biomarkers, biopsies, etc.), increasing the administrative burden of trials.
  • More complex Case Report Forms (CRFs) including many data points can significantly increase trial monitoring costs.
  • Sponsors unnecessarily collect data that may not even be relevant to the specific study.
  • The lack of standardized CRFs and trial procedures across study sites can result in improperly conducted procedures or inadequate data collection at some sites.
  • According to a Tufts Center for the Study of Drug Development (CSDD) study, nearly 60 percent of all trial protocols require amendments, a third of which are avoidable.
  • Industry-sponsored trials are generally monitored through site visits that take place at intervals defined by standard operating procedures or study-specific monitoring plans. It is common practice to conduct site visits frequently, and source data verification (SDV) is a time-consuming part of these visits.
  • Legal advisors have traditionally encouraged sponsors to be conservative in their reporting of unexpected SAEs (at least prior to March 2011, when a new drug safety reporting regulation was implemented).

 

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