A clinical protocol design also known as a medical or clinical guideline is a document that focuses on the guiding decisions and criteria concerning diagnosis, management and treatment in particular fields in healthcare (Peace & Chen,2011). Clinical trial protocols, therefore, include what types of people participate in individual tests, procedures, and schedules for the tests, medication, dosages and the average length of the study. Protocols are grouped into two; protocols designed for new drug approvals and protocols intended to increase the existing scientific knowledge base.
Among the two, rules designed for new drug approvals are primarily crucial because, during the preclinical development, the benefactor’s sole goal is to ascertain if the drug is fit for human use. Here, actual trials are done on people following clinical research phases. These clinical protocols include a patent description of the trial designs as well as patient selection criteria. Also, descriptions of clinical procedures, lab tests and measure to be taken in the monitoring of the effects of the drugs are included.
Drug approval protocols also include previous experience with proposed primary endpoints discussed with the relevant scientific references, biomarkers, outcomes or even patient reported outcomes. Also, rules for adverse events collection and such things as recording are thoroughly described here.
On the other hand, for protocols that are intended for increasing the existing scientific knowledge base are concentrated on specifying the details of all the elements of the study that are significant to safety. Such include clinical safety assessments, description of toxicity-based stopping rules and toxicity monitoring. To cut the story short, protocols designed for new drug approvals are generally more detailed and require a lot of background information than their counterparts.