Doctors

Doctor's are busy. Clinicians are busy. So many professionals ask the question, "What is the benefit of clinical research because I just don't have the time?"

Community-based clinical trials are essential to patients and the pharmaceutical/biotech industry because it is the point of access to experimental therapies that can help with everything from Acne to Zollinger-Ellision syndrome.

Doctor: Resource for Patients 

Trained investigators are a resource for patients because they can see their own doctor for treatment and participation in a study. 

Doctor: Time with Patients and Best Treatment 

Clinical trials offers patients the opportunity to have more time with their doctor (physician or dentist) because the time that you spend is part of the clinical trial program and the grant provided by the sponsor. Plus, patients have the opportunity to receive diagnostic techniques (i.e., MRI, CT, PET) that may not be covered by their insurance provider at no cost, as part of the clinical trial.

Doctor: Additional Practice Revenues

Principal investigators have the opportunity to participate in clinical trials that can increase their practice revenues with very little additional work. In JAMA reports that "half the revenue of academic medical centers comes from clinical work". Although, this may not be the case for a solo practice or a group practice participation in sponsored clinical trials can increase the overall revenues of the practice, if managed well.

Phase I - Experimental therapy is tested for the first time in humans. Often given to a small population of healthy volunteers. Primary goal is to determine safe dosage range for humans.

Total number of research participants = 20- 80

Duration = 3-6 months

Phase II - Phase II study participants have the targeted condition and no concurrent illnesses. Main objective is to determine minimum dose of the trial medication that is maximally effective (or sufficiently effective) with undue toxicity.

Total number of subjects ranges= 100-300

Duration = 1-3 years

Phase III - Phase III studies large number of study participants. Study participants are more representative of the population as a whole. Generally, compares experimental agent (s) with approved medications.

 Total number of subjects ranges= up to 3000

Duration = 3-5 years

Phase IV - Phase IV  is research conducted after medication is approved by the FDA.

Every phase must be approved by the FDA and an IRB. Clinical investigators are aware of the four phases of research (I-IV) but many doctors need help with the clinical management of the study at their site, after they receive approval to be a clinical site. Sephmer helps you with all of that and much more.