I need to develop a budget for a phase I/II and Phase III clinical trial. Any resources or tips? For an antidepressant and also an immunology drug. Thanks!!

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This shouldn’t be a new type of exercise for someone at BCG. Would recommend getting examples of other therapeutic areas that have been done so you have an understanding of the basic budget items (I.e. CRO investigator recruiting, AD Boards, clinical trial recruitment and participation, etc.). Good luck!

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I haven’t done it before! And I’m not comfortable asking around at BCG because it isn’t case related. Helping a friend.

There are journal articles giving cost of clinical trials by TA and Phase, also broken down on a per patient basis. Use this later figure.

Then find trials of comparable approved drugs on clinicaltrials.gov. These will provide relevant patient numbers.

Immuno will be straight forward. Psych drugs often require 3 pivotal trials, so can be confusing to benchmark and costly.

You can use the above to get your 80/20, close enough estimate.

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Amazing. Really appreciate it!

Tons of publications and free tools available https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6907219/ found this in a quick pubmed search https://l.smart-trial.com/ecrf-template

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Thank you!!

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