Sander O Intra-articular corticosteroid injections with the reciprocating procedure device reduced procedural pain and duration more than the conventional syringe. Evid Based Med. 2007 Aug;12(4):106.
Sibbitt RR, Palmer DJ, Bankhurst AD, Sibbitt WL Jr Integration of new safety technologies for needle aspiration of breast cysts. Arch Gynecol Obstet. 2009 Mar;279(3):285-92. doi: 10.1007/s00404-008-0710-8. Epub 2008 Jun 21.
Sibbitt RR, Palmer DJ, Sibbitt WL Jr Integration of patient safety technologies into sclerotherapy for varicose veins. Vasc Endovascular Surg. 2008 Oct-Nov;42(5):446-55. doi: 10.1177/1538574408318479. Epub 2008 Jun 25.
Sibbitt RR, Palmer DJ, Sibbitt WL Jr Reciprocating procedure device for thyroid cyst aspiration and ablative sclerotherapy. J Laryngol Otol. 2009 Mar;123(3):343-5. doi: 10.1017/S0022215108003551. Epub 2008 Sep 17.
Sibbitt RR, Sibbitt WL Jr, Palmer DJ, Bankhurst AD Needle aspiration of peritonsillar abscess with the new safety technology: the reciprocating procedure device. Otolaryngol Head Neck Surg. 2008 Aug;139(2):307-9. doi: 10.1016/j.otohns.2008.04.003.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
