Data & Safety Monitoring of Clinical Trials [NIDCD Research]

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Data and Safety Monitoring of Clinical Trials

Policies and Procedures

In keeping with the National Institutes of Health Policy for data and safety monitoring (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html and http://grants.nih.gov/grants/guide/notice-files/not98-084.html), it is the policy of the National Institute on Deafness and Other Communication Disorders (NIDCD) that all clinical trials funded or conducted, in whole or in part, by the NIDCD have in place a system for appropriate oversight and monitoring to ensure the safety of the participants and the validity of the data.

For multi-institutional phase III clinical trials, appropriate oversight and monitoring is carried out by a data and safety monitoring committee. Depending on the risks to the participating individuals, phase I and phase II trials may also benefit from monitoring by a data and safety monitoring committee.

The Data and Safety Monitoring Committee (DSMC) is a multidisciplinary group which consists of 5 to 10 members including an independent biostatistician, a bioethicist, and individuals with expertise appropriate to the study at hand. The DSMC will approve the protocol, propose appropriate analyses, and periodically review data on safety and outcome. Nominations are solicited from the principle investigator, complemented by National Institute on Deafness and Other Communication Disorders (NIDCD) candidates. Nominated individuals are contacted by the NIDCD to ascertain their willingness to serve on the DSMC and to obtain a curriculum vitae; the NIDCD will make the final selection and issue a formal letter of appointment. The term of appointment extends through the last day of patient follow-up; member services required after that time will be arranged on an ad hoc basis. Each member of the DSMC will be provided a copy of the study protocol and information concerning the NIDCD policies regarding DSMCs.

DSMC members are responsible for assuring, to the extent possible, the safety of the study participants and the integrity of the study. The DSMC monitors, evaluates, and makes recommendations to the NIDCD regarding continuation, termination, or modification of the trial. The DSMC does not initially evaluate the scientific merit or methodology of the study nor does it participate in the study’s conduct.

It is of the utmost importance to avoid even the appearance of conflict of interest. Accordingly, DSMC members shall not have any financial, contractual, scientific or collaborative relationship with any individual or group involved with the trial. Persons who participated in the development of the study (or who are from the same institution as those playing a key role in the study) and persons in industry (for those studies involving the evaluations of industrial products of potential commercial value) will not be considered for DSMC membership. Each DSMC member will be provided with a copy of the National Institutes of Health policy on conflict of interest and confidentiality. A statement of disclosure will be required by the NIDCD and will be updated periodically.

The DSMC evaluates the study progress according to best current biomedical research practice and will be provided interim results, the confidentiality of which must be preserved at all times. Reports regarding quality assurance will be made available to the DSMC upon request.

The major duties of the DSMC are to:

Assess whether the study should continue, undergo modification, or be terminated. Factors to be considered include, but are not limited to: participant accrual, overall study progress, intervention efficacy and any adverse effects, ethical concerns, the quality of monitoring, adherence to the protocol, and reports from the participating units of the trial.
Evaluate each participating center and make recommendations regarding its continued participation, probation, or termination.
Review and approve the protocol, and make recommendations regarding modification where deemed necessary.
In an advisory capacity, review and accept proposed new protocols.
The Study Statistician prepares an outline of reporting procedures (e.g., graphs and tables) that will be used to present study data. The DSMC is encouraged to critique the proposed biostatistical monitoring procedures at the initial meeting, and to make recommendations/suggestions for improvement. New or different data displays may be requested at subsequent meetings. The Study Biostatistician will prepare and distribute an interim report one month prior to each meeting of the DSMC, as well as additional reports as requested by the DSMC.

Meetings of the DSMC will be conducted in three portions. The first, or open, portion comprises discussion of non-confidential, non-blinded study issues; the study chair and the study biostatistician are expected to participate, but other interested individuals may attend as well. In the second (semi-closed) portion, confidential/blinded data are reviewed; the study biostatistician is the only member of the investigator group allowed to attend. The third portion (executive session) is restricted to DSMC members and NIDCD staff, and is the venue in which the formulation of DSMC recommendations regarding the study takes place.

The Project Scientist of the Clinical Trials, Epidemiology and Biostatistics Branch, NIDCD, will serve as the Executive Secretary of the DSMC. The Committee Chairperson will be selected by the NIDCD and will be responsible for chairing the meetings and approving a brief report to be submitted to the Director, NIDCD, within one week of the meeting. The DSMC, via its report, recommends any actions it judges necessary or highly desirable. The DSMC does not have enforcement responsibilities. The NIDCD is responsible for the implementation of any recommendations. In general, the DSMC will review study progress at least every six months, but may vary the frequency of review as deemed necessary.

DSMC members shall not consult with members of the study group, nor may they respond to queries from members of the study group. All such communication should be discouraged. The DSMC must remain independent of Cooperative Group and trial personnel.

Each DSMC member will receive a consultant fee, plus reimbursement for lodging and travel expenses.

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