Stud­ies — Why stud­ies are so impor­tant for 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.

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).

Inform — edu­cate — participate

Would you like to know more about stud­ies and what options there are to par­tic­i­pate? Fur­ther infor­ma­tion can be found in:

“Study por­tal gyne­co­log­i­cal can­cer” of the Char­ité Berlin