3 ques­tions, 3 answers on ovar­i­an can­cer studies

Stud­ies

A “col­lec­tion of ques­tions” can­not and does not want to replace the doc­tor-patient con­ver­sa­tion, but rather should serve as an ori­en­ta­tion and moti­va­tion­al aid. The per­son­al con­ver­sa­tion is and will remain the indis­pens­able basis for a good doc­tor-patient relationship.

Many sci­en­tif­ic stud­ies have shown that “informed patients” were less afraid of the can­cer and were over­all more sat­is­fied with the med­ical care.

Ques­tion:

What is a med­ical study and how is it created?

Answer:

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 harm­less for the patient and has advan­tages over oth­er drugs or con­cepts. Clin­i­cal stud­ies are there­fore imper­a­tive to make progress in can­cer treat­ment and to devel­op the best and most effec­tive ther­a­peu­tic strate­gies for patients.

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 fed­er­al author­i­ties 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.

Ques­tion:

What are the ben­e­fits of par­tic­i­pat­ing in a study?

Answer:

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 the oncol­o­gist M. Gnant (for the study: click here) was able to prove in a study that breast can­cer patients 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.

Ques­tion:

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

Answer:

First of all, it should be empha­sized once again: 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 B. after stud­ies of the Ger­man study groups AGO (Work­ing Group for Gyne­co­log­i­cal Oncol­o­gy) and NOGGO (North-East Ger­man Soci­ety for Gyne­co­log­i­cal Oncology).