Examination of Clinical Trial Costs and Barriers for Drug Development. E.3.5 Regulatory and Administrative Barriers


  • U.S. regulations pertaining to clinical research could benefit from revisions. They were written at a time when the clinical trials enterprise was smaller and before multicenter trials became common.
  • Ethical / Institutional Review Board (IRB) Approval (21 CFR 56)
    • There is often a lack of clarity regarding the roles and responsibilities of various oversight bodies and what is expected of investigators.
    • If the IRB process results in a request for changes to a trial, investigators may lack the resources to fulfill the request.
    • Regulations vary by geographic location.
  • Informed Consent (21 CFR 50) – The process of obtaining informed consent from trial participants is lengthy.
  • Patient Privacy: U.S. Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Part 160 and Subparts A and E of Part 164) – HIPAA requires patient authorization to use their health information for research. There are severe penalties for violating HIPAA, so IRBs enforce compliance. One result of HIPAA and other privacy laws is that site investigators are reluctant to attempt to contact patients to follow up on major outcomes if the patient drops out. This in turn reduces statistical power.
  • Regulations Governing Clinical Trial Conduct – Regulations governing the conduct of clinical trials were devised when trials were smaller and involved fewer sites.
  • Regulations Governing Serious Adverse Events (SAEs) Reporting for Investigational New Drugs and Biologics (INDs) (21 CFR 312) – In the past, FDA and investigators in multicenter trials have been flooded with expedited reports of serious adverse events which lack sufficient context from the aggregate data to be interpretable. A new safety reporting regulation (effective March 2011) may remedy this problem, but it is too early to tell.
  • Regulations for Multiple Jurisdictions – Local, regional, national, and international regulations/guidances are numerous and not always well harmonized.
  • Inadequate Clarity/Consistency/Practicality in FDA Guidance
    • Delays can be caused by differing interpretations of regulations by the various parties involved in multicenter trials.
    • Guidance is lacking for newer therapeutic areas or classes.
    • In disease areas where guidelines are nonexistent, old, or otherwise lacking, sponsors find it difficult to understand FDA expectations before beginning their studies.
  • FDA is understaffed and underfunded and the available resources end up being overtaxed.


View full report


"rpt_erg.pdf" (pdf, 1.89Mb)

Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®