0; eo Dons lr | CLINICAL DEVELOPMENT. OF DRUG, “Iptrodudion to dinial Trails: 2 > clintal both oy Sve research Studies ferformed in human yp __ that _are ain luntecrs Surgiadl. or behavioral ved ad evaluating, medial, _intowention, [2 the goal a} FOr research fe te gana Heal _knowsle about hunar healt and illness, and says >_prevock dat ee ee | Typ 2h studies. |_ Of Non- Experimental © | Experimenta Cose_ report. + Randomized chine drial + Cose Ceres : rer) Cross-Sectional sbudies * Case- Conbol * Cort > Shon _ observational, say Tnvestigetes assess health outcome Iw gross of fosticibonts attording do rerearch plano froocet. > participants rray ceceive interventions (ushich cam include nig, ov devicu!) or _prowdures ay past ch their routine media) Cau, but pesticipants aie hot assigned fe _sherlye interventions by the Investigator. ——_[Dnteventional luda) Celiicel bit) 2A bye died shady ta hid fash trepe aay STN _ aie —_ ignecd_49_grovps — thal —reentve one or more ltteer | he chen | Cor no tulaventin) to dhat yucarches Con evaluate the eect | ofthe intewendions om _biosiedical or heatheraledecl sulomey, 7 the assignments art detested by ths Stal 5 prohoeet, | = poche pant retaken Aixgionh's 1 herspaskts oles dyben ef, tuckerwenchions, 3 (Research Protocd|- = the written deceniphion oe clinical shud. A tectuden the sacha’ chicetives Auign oud sethad, and May slco inchade eltvant Stientily eackground sre Shediial isfomankion : > the tacarch « profoeul rust Cheong alewwhe the, Flowing osberbe of vthe research. Huda + toby the study i bug done, + hak will be done in he “ty é *tghere the shut eit) te done (_ Sibe-dfeuilve infortsattin), t who ig involved fin the researele shade other Shadi intevertions vill teler blag. > H_ mut be _ctpmaved by the. design teq TRB bore ie rascarch gins Ang” chang do the potatal (fraftel_stundnat) must also be obyraved by dhe TRB 2 Scleetion Gritete Aafone hich _Subjeck fo nelude ( inclusion) 2 tshich 4o_exelude (ev etueian Criteria): > Lgutiietion of sbpropuinde fesbuparh _ based om Becton seh 4| DOMs [ra Ny { age genders the ‘pe aud Hoge ob the disease, previous Areecmnent haley aud other medical Conditions, goth Crdlusion Gileia 9 Conconitant therwpy thet Moat effect Ay louse ofthe disease or Noy Med to dug i Meractins 5 pragma] sooner muning ethos che, 2 Bias im _clinicel_tviels may be described ay sypteraic crore that encourege one outcome over others. Lp the _potechiah efecto, bias is that: dinves tig eons will_come othe sarong Conclusions about the benefivel and harmbul alee a interventions : + Selection Bias- A Sample needs fo be representative of the population. Tp cthis_is wat _th, Case , Conclusions will not be gencralizavle ae qe Daring. fatient recruitment , some patients ave ters ov more Uhely, fo__euter the Shidy thon others, such Sample sould not be represeala bre ck the population tw which this vescarch it di | To climinode Selection bias, shudiec:- pre Couducted on a _ randomized fashion. social 3B - a [+ Observer bias - Tt necurt shen the investigator _aavare oh the _ —_|__ disease status, treatment group or oulome of the Subjert_ end their ability to _tvberviews the Subject, coltect or _anclyce the. | dale in on unbiased manner is Gujromised is Randomization ancl bbindiag ere the ‘too lechaifuen _wsuetly used bias and to ensure thet Bee maimimige he Chance’ oly Suchf {| | Note: the tert and Conbot groups shad be elt baseline and Similar with regard do all an Ahat influence outome on bendonent Waviabtes ‘hel ne ty a | the Aes Weshuent ancl Cobol _qroujs are a eal a] | Start aj the shady ana ave treated Siewtlariy ig oy, > M the / EF ol cthe study. ni ae “y _- [Randowizadion | = SS a | Assurance that Subject _populadions ave Harta Fl Hit Cobal_groupt is best attained by “eel —Sg ‘im Sivale Semple fopilabvon tto! groups hak “eth ta i > Revlmutealion + muatde —ytenit diffeores bebocon ous uy rabeet_de tuo oy unknown baseline Veatabler thet Gag ud Sfhect ovine. Blinding = 1 v bt > The geups_ should not only he similar at baselrae, but thay be_treated and ebserved Sinilady duving the rial exept for_vecdweg thw lest ond’ Guhal dng. ~ blising i tflowded to _miniwize the potewbiel biases reaing resulting from differences in Mowogement treakment a asin Sh patients or _indlarbredechion ofy__results thet Coutel anise % © Mesut ef Subjedt oy Iaveshpatoy Pnnisledgas of the angel Areodmnenc | > blinds: is intended de ent est linding i ed cusure thet Subjebine en tid dtc, ore rot aused yg Iauledge ot belt @ Ssignenent.DOMES | pape No bat Tae 5 _| fe 2 Subjects pn active. dwg agit _veport more favor ble | oukteme because - expect © benefit onl observers veil be | Nes Wi pe shed identify ad report Aveahmart” | veapons o= brentment groupe a [Cena] . : 7 SF athe group oly _Varhiibants that vectives _slawderd _treahunat | ora placebo» Researchers _Combare - vesults from the Cobol - group with rerulls ae ut ” Aoi Abe experimental group to find avd learn Som any differences. Tpes of Cowbols 1 ase ges + pet frectnana t Method of eterming ra used ; who wit be fn the | Cousot group $ > =i = J Meebo No kestnent Dilfecent doy —dijfurnt 65 placebo Concurrent i or egimen of active Covsrst the “study treatment = breatment 1 No-breatment Concuvett _ > the fist four _ore Gncunendiy Corbotled ‘5 paisRapeat Coane ose ~ Response Concum Gre Canbot group ouch test groups are Cantu “a chosen fom the _Seme_pahutation aud Ly Aetive Chasis) : Conewwent. Contrel ates beaded Corzsrentty) Crlernal Conbrat —x usual with random assignment _49 Aresdrnent } Etnetacting atatorcat ) | thug are _didingunheel by the type Gob re ! Huatple Nyeobetauc « ‘arnubs| = > External or AMistorical Control = main, Tt | le Seferate fom “he bobs 7 ation in the bial, oti { Types of Clinienl Thiate.- G) Preventive dials > this fiat used to tek “nao Medications lndludieg y as ove _Supplenenh , 04 toell as Vacerney ancl ov i te « thet mast Oya \ kof Catan att. oy Conditions +h , ‘ , ~ oe = wy de neat —faape Sed dit, ws fearing h Certain Conditions Such 9 Cone, cud ous yes ce ferent it tom Coming back ai) Screening dials! ~ these biats atm 40 find the but Lap do detect Gren diseases or Caudiitions prior _to pedicuk csferienting Synths 7 thee bale ove ft used Pp detepmine if tarbier_dekechin oh —illresnes deneaten person - visk Sevisus kann or deadhn (81) _Diagnortte Thake : > ahs type of ale refers to sts Sueube prachie eh — Looking fo wes ond better wou to identify Certain dlseates or Condations, 45 7? Th shidin Veatous tess ov procedures thet Can wore —}——reuurslly ditee te illnenis Othe brat wiustiy ictal pend who gee slat a?3 these__bials involve _ aw _Gheienusg Signs and Syrabdoms _ Studia — a Cie) Treatment (Trtervertion ) dei psgchotheespy 1 a me device or 0 Mew ebproach osu ey of th Gudkitive beng Such a9 medication , __2¥__anether _tippe of, therapy or _beatment. nest _typer of vals are focused on Finding nus treatment for Veviows —_dseasey ov Conditions by Calleeting data aud ensuring “ths, Sefeta of —pesticipauty » while also erstustoeg, the oy device. dre q Lv) Gagnehie studi « | Aim 4 _inabrove _brecretors eI in dh ition identifi ke how & vole in Cedain illmes | A Reseach Conducted in thas ape Shel Oe earns hous & _benon's get _might make hia or hee more dy less of risk of devebop iva, Certain 3 this is nabortouct i disorden. — determining Vorinur treatments _ (vi) Quality ls Life Studien + this type of research _ dim do find Loa eo _ evaluate a _perton's Comfort and quatity of Uke _uhen hey are Saher from throne _ illness, —- cthis_sludy Can alo _detemine he bot seus of _monsgg Side _etheds ol, Various disease crs well a» ——induding house , Vort chemotherpy awd used a1 Conditions ond treatments depression asnuicked witlh Cane _| in beking Cancer.D0Hs'| Date / CN) Epidemiol shadies + Research oblamed inthis type 4 thay helps Scientists 49 identify prevalence petleens , Gses aud Various groups of peple, Guts ofclifterewt —clisorden th [Benin Ojcaing Pera 509): > SOP: derevibe in detail how spevfpe roceduvea Cope teking Vitel Signs fucking wine Ast and asiag advert ertnb ) dre fe be Comied out inthe _researth Study. Most Sop, vill be “identical for ell Study Sitter. However, in Some cases side-shecrfie Vvariediont are needed. Foe Grample, if protedures for handling. 6 medicel emergency Vary slighty Aron one _reiearch sibe do _austher’, the SOP ‘or speuipe Site will reflect chore Varvations. these _pvoreduren ef