Brice A, Price A, Burls A Creating a database of internet-based clinical trials to support a public-led research programme: A descriptive analysis. Digit Health. 2015 Nov 20;1:2055207615617854. doi: 10.1177/2055207615617854. eCollection 2015 Jan-Dec.
Fletcher AJ, Marchildon GP Using the Delphi Method for Qualitative, Participatory Action Research in Health Leadership. International Journal of Qualitative Methods 2014;13:1-18
Potter S, Brookes ST, Holcombe C, Ward JA, Blazeby JM Exploring methods the for selection and integration of stakeholder views in the development of core outcome sets: a case study in reconstructive breast surgery. Trials. 2016 Sep 23;17(1):463.
Sinha IP, Smyth RL, Williamson PR Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011 Jan 25;8(1):e1000393. doi: 10.1371/journal.pmed.1000393. Review.
Snow R, Crocker JC, Crowe S Missed opportunities for impact in patient and carer involvement: a mixed methods case study of research priority setting. Res Involv Engagem. 2015 Aug 4;1:7. doi: 10.1186/s40900-015-0007-6. eCollection 2015.
Effects of Question Section Order on Prioritization of Items by Stakeholder Groups in an Online Delphi Study
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.
