Analyzing the Parkinson's disease clinical trial pipeline to facilitate patient collaboration in research.
CLINICAL TRIALS BY PHASE and RECRUITING STATUS
7 cognitive therapy trials as of 8/1/17
7 telemedicine/ telehealth trials
as of 8/1/17
7 alpha synuclein trials as of 8/1/17
6 gene therapy trials as of 8/1/17
* includes trials enrolling by invitation
As of August 1, 2017:
CLINICAL TRIALS WITH RESULTS submitted on CLINICALTRIALS.GOV
... and click on country to view by state and by individual trial.
CLINICAL TRIALS BY THERAPY FOCUS
CLINICAL TRIALS BY PHASE
Note 1: 22 of the trials in the above chart are combined Phase 1/Phase 2 OR combined Phase 2/3.
Note 2: 426 total active trials = 271 recruiting + 60 not yet recruiting + 26 enrolling by invitation + 69 no longer recruiting.
An INTERVENTIONAL STUDY (or Clinical Trial) is a clinical study in which participants are assigned an intervention such as a medication, device, or procedure, so that researchers can evaluate its effects on biomedical or health-related outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions. See trial phase descriptions at bottom of page.
As of October 7, 2017, there were 426 active PD interventional studies worldwide listed on ClinicalTrials.gov. This includes trials that are recruiting, not yet recruiting, enrolling by invitation or no longer recruiting.
TRIAL PHASE Definitions
Food and Drug Administration (FDA) categories for describing the clinical trial of a drug based on the study's characteristics, such as the objective and number of participants. There are five phases:
Early Phase 1: Exploratory study involving very limited human exposure to the drug, with no therapeutic or diagnostic goals (for example, screening studies, microdose studies)
Phase 1: Studies that are usually conducted with healthy volunteers and that emphasize safety. The goal is to find out what the drug's most frequent and serious adverse events are and, often, how the drug is metabolized and excreted.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). For example, participants receiving the drug may be compared with similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing. These including postmarket requirement and commitment studies that are required of or agreed to by the sponsor. These studies gather additional information about a drug's safety, efficacy, or optimal use.