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101 Facts About Clinical Research

101 Facts About Clinical Research



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Published by nicky02
Ppl Who want to Know abt Clinical reserach
Ppl Who want to Know abt Clinical reserach

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Published by: nicky02 on Jan 06, 2009
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1.More than 2.3 million people participatein approximately 80,000 total clinicaltrials every year throughout the US.
2.50,00060,000 of these trials areindustry sponsored, while theremaining are government sponsored.
(Institute of Medicine)
3.In the past 20 years, the averagenumber of patients per trial increasedfrom 1,700 to more than 4,000.
4.In order to meet expected demand, thenumber of respondents to clinical studypromotions will have to increasesevenfold, from 2.8 million in 1999 to19.8 million in 2005.
(Applied ClinicalTrials)
5.From 2001 to 2004 the number ofpeople who stated that they had theopportunity to participate in a clinicalresearch study increased by almost50% from 13% to 19%
(Harris Interactive,May 2004)
6.The average number of participantsneeded for a new drug trial jumpedfrom 2270 participants in the 1980s to3,700 participants in the 1990s.
(Food &Drug Administration)
7.Studies have shown that while 44% ofpeople find out about studies throughthe media, only 14% gain theinformation from their physicians.
8.80% of total trials are delayed at leastone month because of unfulfilledenrollment.
Facts about 
9.In 2003, 22% of studies werecompleted with a one month delay,while a whopping 72% of studies sawa delay of over one month.
10.Surveys have shown a trend towardpoor volunteer retention in studies, asoverall only one out of every four(73.2%) of volunteers stick with astudy until its completion. Most drop-outs occur during phases II and III.
(CenterWatch, 2003)
11.From 1997 to 2003, the percentage ofstudies completed on time decreasedfrom 18% to 6%.
12.Only 30% of clinical trial participantsreport that they first learned about aclinical trial from their primary/specialtyhealth care provider –mostinformation comes from media or theinternet.
(Institute of Medicine)
Published July 2005
Volunteer ParticipationPublic PerceptionClinical Research ProcessCost of ResearchAdverse EventsPhysician InvolvementMinoritiesWomenElderlyPediatricCancerHeart DiseaseHIV/AIDSLung Disease
13.One study showed that 10% of volunteersdid not look at the informed consentbefore signing it; 18% signed withoutinput from their personal physician, nurse,family member, or trusted; and 70%reported that, at the outset of the informedconsent process, they did not know whatquestions to ask.
(Applied Clinical Trials)
14.Most adult cancer patients whoparticipate in clinical trials say that aphysician had a great deal of influence ontheir decision to participate.
15.Even though most people do not rely ontheir physicians for information, 78% ofthe public say the physician is their mosttrusted source of information.
16.In a recent poll, 94% of people recognizethe importance of participating in clinicalresearch in order to assist in theadvancement of medical science. Yet75% of the general public state that theyhave little to no knowledge about theclinical research enterprise and theparticipation process.
17.Despite distrust, from 1995 to 2003 thepercentage of people who believed thatclinical research was important inadvancing science increased from 83% to94%.
(Carlton Research and Harris Interactive)
18.The major factors people look at whenconsidering participation in clinical trialsincludes “If it would benefit me orsomeone else” (58%). “If I knew all aboutthe risks” was second (48%); “If the riskwas minimal or if the reward outweighsthe risk” was third (35.3%); “For a cure”was fourth (35.2%); and “If my doctorrecommended it” was fifth (34.5%)
19.An overwhelming majority of people(77%), say that they would considergetting involved in an appropriate clinicalresearch study if asked; however, only10% of those eligible to participate inclinical trials do so in the United States.
(Harris Interactive)
20.Only 12% of survey respondents statedthat they have spoken with their doctor orhealthcare provider about clinicalresearch.
(CISCRP/ODC Survey, 2004)
21.From 1996 to 2002, the percentage ofthe public who distrusted informationreceived from clinical researchprofessionals increased from 28% to75%.
(Research America / Harris Interactive)
22.Two-thirds (66%) of Americans think thatclinical research studies are safe forthose who participate.
23.More than half of respondents wouldhave greater trust in clinicalresearchinformation if the results were madeavailable on a public website registry.
24.It takes approximately 10 years of studyin test tubes and laboratory mice to reachthe point where a treatment might betested for its safety and effectiveness inhumans.
(Ken Getz, Informed Consent)
25.A clinical trial is sometimes called aclinical research study or a researchprotocol, but a clinical trial primarilyrefers to the location where a studyprotocol is being tested. In other words, asingle protocol involves multiple locationsacross a variety of cities, states and evencountries where clinical trials areconducted.
(Star-Ledger Staff)
26.Approximately one in 50 drugs that enterpre-clinical testing prove safe enoughand effective enough to be tested inpeople.
(Ken Getz, Informed Consent)
27.In the 1960s, it took 8.1 years to developa new drug; in the 1990s it tookresearchers 15.3 years, or nearly doublethe time.
(Association of ClinicalResearch Professionals)
36.The FDA review period usually lastsabout one year for most New DrugApplications (NDAs). The FDA alsohas an expedited review process forpriority drugs—usually lasting under sixmonths. Priority drugs are those thatrepresent a notable treatment benefitfor critical and severe illnesses.Approximately60% of all NDAsare approved bythe FDA.
(Ken Getz,Informed Consent)
37.About 80% ofdrugs that enterphase III willsuccessfullycomplete thisstage.
(Ken Getz,Informed Consent)
38.While the pharma-ceuticalindustryhas increased research anddevelopment spending over the past 20years, to a record $30.5 billion in 2001,the number of new drugs has notincreased in proportion.
(Applied ClinicalTrials)
39.Drug companies have been increasingtheir R&D spending by about 6% ayear since 1995. The Center forMedicines Research Internationalproject that will total $55 billion at theend of 2005.
(Economist, June 18, 2005)
40.The average HIV drug cost $479m tobring to market.
(Economist, June 18, 2005)
41.The average cost to bring a rheumatoidarthritis drug to market is $936 million.
(Economist, June 2005)
42.The average American spends almost$5,000 a year on health care. Lessthan $20 of that amount is invested inresearch to prevent, treat and curediseases and disabilities.
43.In all, it may take as much as 20 yearsto bring a single new drug treatmentfrom its initial discovery through to themarket.
28.Only one in five drugs that enter clinicaltrials will prove safe and effectiveenough to receive FDA approval. Andsome of these drugs end up beingmost effective for patients with differentdiseases than those that they wereoriginally created to treat.
(Ken Getz,Informed Consent)
29.More than 120 new remedies get theFDA’s stamp of approval every year,including a handful of “breakthrough”drugs that provide the first effectivetreatment ever for a variety of medicalconditions.
(Ken Getz, Informed Consent)
30.Even relatively small improvementsto existing drugs, which represent over40% of new drugs approved by theFDA each year, provide importanthealth benefits to patients.
(Ken Getz,Informed Consent)
31.According to the FDA, approximately70% of new medical treatments passPhase I testing stage.
(Ken Getz,Informed Consent)
32.Only about one-third of drugs thatenter clinical testing ever successfullycomplete phase II and progress tolarger-scale phase III studies. Thisstage provides hard, statistical factsabout a drug.
(Ken Getz, Informed Consent)
33.For every, 10,000 molecules screened,an average of 250 enter pre-clinicaltesting, 10 make it through to clinicaltrials, and only one is approved by theregulator.
(Economist, June 18, 2005)
34.Phase III clinical trials involveextensive testing to assess safety,efficacy and dosage levels in a largegroup of patients facing a specificillness. The study drug is tested on asmany as several thousand people overa period of two to five years.
(Ken Getz,Informed Consent)
35.Therapies that have reached phase IIIhave already passed toxicity testingand have proved to be at leastsomewhat effective. But subjects inphase III trials still usually have nobetter than a 50% chance of getting theinvestigational treatment versus aplacebo or standard therapy.
(Ken Getz,Informed Consent)

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