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NIH clinical trial model

NIH Clinical Trial Model. Safety and Data monitoring regulations in Clinical Trials.

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NIH clinical trial model

  1. 1. NIH Clinical Trial Model ALAA EDDEEN ALQAISI, MD PHCI 624 -01 – FALL 2014 1
  2. 2. 2 Fundamental Point During the trial, response variables need to be monitored for early dramatic benefits or potential harmful effects. Preferably, monitoring should be done by a person or group independent of the Investigator. Although many techniques are available to assist in monitoring, none of them should be used as the sole basis in the decision to stop or continue the trial.
  3. 3. 3 Thus NIH Clinical Trial Model ensures mainly Safety and Data Monitoring
  4. 4. 4 Steering Committee NIH Policy Board Monitoring Committee Central Units (Labs, …etc) Institutional Review Board Coordinating Center Clinical Centers Patients NIH Clinical Trial Model
  5. 5. 5 Steering Committee Pharmaceutical Sponsor Independent Monitoring Committee Central Units (Labs, …etc.) Institutional Review Board Data Coordinating Center (Sponsor or Contract Organization) Clinical Centers Patients Industry-modified Clinical Trial Model Regylatory Agencies Statistical Analysis Center
  6. 6. 6 How could data monitoring in clinical trial indicate early trial termination? If data part-way through the trial indicate that the intervention is harmful If the data demonstrate a clear benefit from the intervention, because to continue it would be unethical to the control group If differences in primary and secondary response variables are so unimpressive
  7. 7. 7 In 2000, as a result of death of young person in gene transfer research, the U.S. Secretary of Health and Human Resources issued a requirement that all trials sponsored by NIH or under the regulatory review of the FDA have a monitoring plan. For Some trials this entails an independent monitoring committee.
  8. 8. 8 Data and Safety Monitoring: • NOT Simply a matter of looking at tables or Statistics analysis of the outcome • BUT it is an active process in which additional analysis is suggested and evolve as a result of ongoing review.
  9. 9. 9 Who is responsible for Safety and Data monitoring? NIH Guide: NIH policy for safety and data monitoring: Release date June 10, 1998 “This policy provides each IC (Institution & Center) with the flexibility to implement the requirement for data and safety monitoring as appropriate for its clinical research activities. Thus, IC staff may either conduct or sponsor the monitoring of data and safety of ongoing studies or delegate such responsibilities to a grantee or contractor. Oversight of monitoring activities is distinct from the monitoring itself and should be the responsibility of the IC regardless of whether the monitoring is performed by NIH staff or is delegated. Oversight of monitoring must be done to ensure that data and safety monitoring plans are in place for all interventional trials, that the quality of these monitoring activities is appropriate to the trial(s), and that the IC has been informed of recommendations that emanate from monitoring activities.”
  10. 10. 10 Who is responsible for Safety and Data monitoring? (cont'd) NIH Guide: NIH policy for safety and data monitoring: Release date June 10, 1998 “Monitoring activities should be conducted by experts in all scientific disciplines needed to interpret the data and ensure patient safety. Clinical trial experts, biostatisticians, bioethicists, and clinicians knowledgeable about the disease and treatment under study should be part of the monitoring group or be available if warranted.”
  11. 11. 11 Performance of Safety and Data monitoring NIH Guide: NIH policy for safety and data monitoring: Release date June 10, 1998 “The ICs will ensure the integrity of systems for monitoring trial data and participant safety, although they may delegate the actual performance to the grantee or contractor. Monitoring must be performed on a regular basis, and conclusions of the monitoring reported to the IC. Recommendations that emanate from monitoring activities should be reviewed by the responsible official in the IC and addressed. The ICs also have the responsibility of informing trial investigators concerning the data and safety monitoring policy and procedures. Considerations such as who shall perform the monitoring activities, the composition of the monitoring group (if a group is to be used), the frequency and character of monitoring meetings (e.g., open or closed, public or private), and the frequency and content of meeting reports should be a part of the monitoring plans. IRBs should be provided feedback on a regular basis, including findings from adverse-event reports, and recommendations derived from data and safety monitoring”
  12. 12. 12 Institutes and centers Responsibilities: (the following are the minimum responsibilities of sponsoring ICs ) • Prepare or ensure the establishment of a plan for data and safety monitoring for all interventional trials. • Conduct or delegate ongoing monitoring of interventional trials. • Ensure that monitoring is timely and effective and that those responsible for monitoring have the appropriate expertise to accomplish its mission • Oversee monitoring activities. • Respond to recommendations that emanate from monitoring activities.
  13. 13. 13 Data Monitoring Committee: • Ideally, participants in monitoring outcomes of a trial are in no way associated with the trial. • For trials that are conducted as part of a cooperative group, a majority of the individuals monitoring outcome data should be external to the group. • ICs should require policies that evaluate whether the participants have conflicts of interests with or financial stakes in the research outcome; and when these conflicts exist, policies must exist to manage these in a reasonable manner. • Data and safety monitoring boards meet first in open session, attended by selected trial investigators as well as NIH program staff or project officers and perhaps industry representatives, and then in closed session where they review emerging trial data.
  14. 14. 14 Data Monitoring Committee: • When "masked" data are presented or discussed, no one with a proprietary interest in the outcome should be allowed. • Participants in the review of "masked" or confidential data and discussions regarding continuance or stoppage of the study should have no conflict of interest with or financial stake in the research outcome. However, if there is an open session, they could be present. • Confidentiality must be maintained during all phases of the trial including monitoring, preparation of interim results, review, and response to monitoring recommendations.
  15. 15. 15 References: 1- Fundamentals of Clinical Trials 4th edition Friedman, Lawrence M., Furberg, Curt D., DeMets, David L. 2- NIH policy for safety and data monitoring: Release date June 10, 1998 3- NIH Website:
  16. 16. 16 Thank You