Studies and Patients

Studies — Why They Are So Important to Patients

Why studies are so important for patients and how to properly inform yourself.

Cli­ni­cal stu­dies are important in demons­tra­ting the effec­ti­ve­ness and safe­ty of medi­cal tre­at­ments. At the same time, most stu­dies are an attrac­ti­ve addi­tio­nal offer for pati­ents. So why you should con­si­der par­ti­ci­pa­ting in a stu­dy, we try to dis­cuss with the fol­lowing arti­cle. To do this, we have used and ans­we­red the most fre­quent­ly asked ques­ti­ons about studies.

For infor­ma­ti­on on par­ti­ci­pa­ting in a gyne­co­lo­gi­cal stu­dy at the Cha­ri­té, plea­se visit us on our stu­dy portal:

“Stu­dy por­tal gyne­co­lo­gi­cal can­cer” of the Cha­ri­té Berlin

What is a study anyway?

A stu­dy is a sci­en­ti­fic inves­ti­ga­ti­on that must be car­ri­ed out befo­re a drug or the­ra­peu­tic con­cept can be appro­ved or beco­me rou­ti­ne cli­ni­cal practice.

A stu­dy has to pro­ve that a drug or a the­ra­py con­cept is effec­ti­ve and safe for the pati­ent and has advan­ta­ges over other drugs or con­cepts. Cli­ni­cal stu­dies are the­re­fo­re abso­lute­ly necessa­ry in order to achie­ve pro­gress in can­cer tre­at­ment and to be able to deve­lop the best and most effec­ti­ve the­ra­py stra­te­gies for patients.

How is a study created?

Befo­re a stu­dy can begin, strict sci­en­ti­fic and legal requi­re­ments must be met. The stu­dy pro­to­col, in which the most important fea­tures of the stu­dy are descri­bed and defi­ned, is drawn up by various »experts« in the respec­ti­ve field using the latest sci­en­ti­fic data, then asses­sed by an inde­pen­dent ethics com­mit­tee and final­ly sub­mit­ted to the sta­te aut­ho­ri­ty for appro­val. In order to con­duct a stu­dy, pati­ent insuran­ce must also be taken out in the event that dama­ge occurs that can be traced back to the stu­dy therapy.

What are the benefits of participating in a study?

Pati­ents who take part in cli­ni­cal stu­dies recei­ve “spe­cial care”. You will recei­ve the latest the­ra­py con­cepts, the veri­fi­ca­ti­on and app­li­ca­ti­on of which are only pos­si­ble wit­hin the scope of the sci­en­ti­fic stu­dy. As ear­ly as 2000, the Aus­tri­an working group led by onco­lo­gist M. Gnant was able to pro­ve in a stu­dy that pati­ents with bre­ast can­cer who are trea­ted under stu­dy con­di­ti­ons live signi­fi­cant­ly lon­ger than pati­ents who do not take part in stu­dies. One of the rea­sons for this is the even more inten­si­ve care and moni­to­ring of pati­ents in cli­ni­cal stu­dies. Stu­dies are the­re­fo­re a qua­li­ty fea­ture of the trea­ting cli­nic or practice.

Plea­se ask about the pos­si­bi­li­ty of par­ti­ci­pa­ting in an inno­va­ti­ve stu­dy so that you have more the­ra­py opti­ons and can par­ti­ci­pa­te in the necessa­ry impro­ve­ment in the suc­cess rates of can­cer the­ra­py for ova­ri­an, fallo­pian tube and peri­to­ne­um cancer.

The Ger­man stu­dy group AGO (Working Group for Gyne­co­lo­gi­cal Onco­lo­gy) was also able to clear­ly show in various ana­ly­zes that stu­dy par­ti­ci­pa­ti­on is a qua­li­ty fea­ture of a cli­nic or prac­ti­ce and that the con­nec­tion to a stu­dy cen­ter alo­ne can offer a sur­vi­val advantage.

The the­ra­py of can­cer of the ova­ries, fallo­pian tubes and peri­to­ne­um should pre­fer­a­b­ly be car­ri­ed out in the con­text of cli­ni­cal stu­dies in order to impro­ve the data situa­ti­on for the pati­ents and to give them ear­ly access to the latest inno­va­ti­ve can­cer therapies.

What are my rights and obligations in the context of a study?

The­re are clear­ly defi­ned rights and obli­ga­ti­ons asso­cia­ted with par­ti­ci­pa­ting in a sci­en­ti­fic stu­dy. If a pati­ent falls ill or inju­res herself as a result of par­ti­ci­pa­ting in a cli­ni­cal exami­na­ti­on, ade­qua­te tre­at­ment will be pro­vi­ded (in accordance with the pro­vi­si­ons of the app­li­ca­ble Medi­ci­nes Act). In accordance with the sta­tu­to­ry pro­vi­si­ons, pati­ents are addi­tio­nal­ly insu­red against pos­si­ble health dis­or­ders cau­sed by the the­ra­py during the cli­ni­cal trial.

Howe­ver, in order to main­tain the insuran­ce cover it is necessary:

  • to start other medi­cal tre­at­ment during the dura­ti­on of the exami­na­ti­on only with the con­sent of the inves­ti­ga­tor (of cour­se, this does not app­ly to emer­gen­ci­es; in this case, howe­ver, the inves­ti­ga­tor must be informed).
  • to take all appro­pria­te mea­su­res to cla­ri­fy the cau­se and scope as well as to redu­ce the damage
  • to inst­ruct the trea­ting phy­si­ci­ans, health or social insu­rers, at the request of the pati­ent insu­rer, to pre­pa­re reports on the dama­ge to health and also to aut­ho­ri­ze them to pro­vi­de information

How will my personal data be handled?

Data and infor­ma­ti­on from your medi­cal records, which pro­vi­de infor­ma­ti­on about the cour­se of the dise­a­se and cer­tain test results, are recor­ded and eva­lua­ted anony­mous­ly as part of the sci­en­ti­fic inves­ti­ga­ti­on. You are assu­red in wri­ting that all per­sons and orga­niz­a­ti­ons invol­ved will tre­at the infor­ma­ti­on recei­ved with the utmost con­fi­den­tia­li­ty. You will not be iden­ti­fia­ble as a per­son in any report of this cli­ni­cal examination.

The data pro­ces­sing is car­ri­ed out strict­ly in accordance with the sta­tu­to­ry pro­vi­si­ons of data pro­tec­tion. All par­ti­ci­pants have the right at any time to find out about the type and extent of the data trans­mit­ted from their doctors.

What questions should I ask my attending physician about a clinical trial?

Regard­less of this, sci­en­ti­fic stu­dies repre­sent the best the­ra­py opti­on for pati­ents, as they not only recei­ve a spe­cial qua­li­ty of the­ra­py and are under spe­cial obser­va­ti­on, but also make an important con­tri­bu­ti­on to other women and to sci­ence so that the the­ra­py can be fur­ther optimized.

Par­ti­ci­pa­ti­on in cli­ni­cal stu­dies is stron­gly recom­men­ded as it is a basic requi­re­ment for fur­ther the­ra­py optimization.

Important ques­ti­ons are:

  • Who is in char­ge of the cli­ni­cal stu­dy? Who is my con­ta­ct person?
  • What is the aim of the pre­sent study?
  • What other cen­ters are par­ti­ci­pa­ting in this study?
  • When did the stu­dy start, when does it end?
  • Which sub­s­tan­ces will I get in the study?
  • How effec­ti­ve are the sub­s­tan­ces? What is their side effect profile?
  • What addi­tio­nal exami­na­ti­ons — out­side of the rou­ti­ne — are car­ri­ed out as part of this study?
  • Am I allo­wed to con­ti­nue taking my pre­vious medi­ca­ti­on during this study?
  • What rights and obli­ga­ti­ons do I have if I take part in this investigation?
  • Will my fami­ly doc­tor be infor­med about this study?

For examp­le, ask about stu­dies by the Ger­man stu­dy groups AGO (Working Group for Gyne­co­lo­gi­cal Onco­lo­gy) and NOGGO (North-East Ger­man Socie­ty for Gyne­co­lo­gi­cal Oncology).

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