The largest program at SMRI is for the identification of medications that will improve the treatment of schizophrenia and bipolar disorder. Although some medications have been available since the 1960s, they have proven to be only partially effective. Many individuals affected with these diseases continue to have symptoms even when taking available medications, while others find it difficult to take medications because of side effects.

There are two parts of this SMRI program:

I.  Regular Treatment Trials

The purpose of this program is to support the testing of medications to assess their efficacy for treating schizophrenia and bipolar disorder. SMRI is especially interested in supporting the testing of medications that are unlikely to be tested by pharmaceutical companies because they are not commercially profitable. At any given time, SMRI is supporting 75-100 treatment trials, the majority of which are on generic and/or off-label medications. To view a list of SMRI-funded trials, click on List of Awarded Treatment Trials. To view a description of a trial, click on the "select" button to the left of the grant identification number.  The list can be sorted numerically/alphabetically by clicking on a column head.

Regular treatment trials can be funded for up to $300,000 per year. Applications must be submitted by October 1 of each year; applicants will be notified of the decision by the end of November.

Questions regarding treatment trials should be addressed to Ms. Rhoda Marte at marter@stanleyresearch.org.

II.  Special Treatment Trials and Drug Development

SMRI also supports special treatment trials and occasional drug development. Special treatment trials are usually multi-center trials that require more than $300,000 per year to carry out. Such trials are usually reserved for medications for which preliminary SMRI-supported trials have been promising.

SMRI has, in the past, also supported the development of promising medications at selected corporate biotechnology companies. At this time, such funds are fully committed, and new applications are not being accepted.

SMRI Data and Safety Monitoring Board Policy Statement

Starting in 2009, the Stanley Medical Research Institute will require that all newly funded studies involving more than minimal risk be overseen by a Data and Safety Monitoring Board (DSMB). DSMBs are currently required for most studies funded by the National Institutes of Health ) (http://www.nimh.nih.gov/research-funding/grants/nimh-policy-on-data-and-safety-monitoring-in-extramural-investigator-initiated-clinical-trials.shtml) and the United States Food and Drug Administration (http://www.fda.gov/CbER/gdlns/clindatmon.pdf ). DSMBs are also being increasingly required for articles on clinical trials submitted to medical journals.

 

At this time, there is some variation in terms of how DSMBs are constituted and what their duties are. We would suggest that DSMBs overseeing SMRI-funded trials meet the following requirements:

  1. The DSMB should have a minimum of 3 members, at least one of whom is outside of the Institution performing the trial. It is strongly recommended that at least one member of the DSMB have proficiency in biostatistics or clinical trial design. It is also strongly recommended that at least one member of the DSMB be able to communicate in verbal and written English.
  2. The DSMB should meet at least once every 6 months. Meetings by teleconference are acceptable.
  3. The DSMB should prepare a written report at least once a year and at the end of the study.  These reports should be submitted to SMRI along with the annual report.
  4. The DSMB should have access to all of the relevant data of the study, including the number and nature of serious adverse events in each treatment arm.
  5. Feel free to contact SMRI with any questions concerning the DSMB or with suggestions for DSMB members.

 

The most comprehensive reference can be found at:


Additional references:

 

  • Wittes J et al. Monitoring the randomized trials of the Women’s Health Initiative: the experience of the Data and Safety Monitoring Board. Clin Trials 2007;4:205–206.
  • Witts J. Forming your phase III trial’s data and safety monitoring board: a perspective on safety. J Investig Med 2004;52:453–458.
  • Lang T et al. Data safety and monitoring boards for African clinical trials. Trans R Soc Trop Med Hyg 2008;102:1189–1194.
  • NIMH Collaborative HIV/STD Prevention Trial. Role of data safety and monitoring board in an international trial. AIDS 2007;21(suppl 2): S99–102.
  • Czaja SJ et al. Data and safety monitoring in social behavioral intervention trials: the REACH II experience. Clin Trials 2006;3:107–118.
  • Hedenmalm K et al. The conscientious judgement of a DSMB—statistical stopping rules re-examined. Eur J Clin Pharmacol 2008;64:69–72.

 

updated March 2009