Should you be part of a clinic trial?

First, many ques­tions need to be an­swered

The Chatham Daily News - - NEWS - CATHY TELFER

Some­times when you are un­der­go­ing treat­ment for cancer or are at risk for de­vel­op­ing cancer, your doc­tor might sug­gest a clin­i­cal trial. Clin­i­cal tri­als are re­search stud­ies that test new ways to pre­vent, find, pre­dict prog­no­sis of, or treat cancer. Canada is an in­ter­na­tional leader in con­duct­ing clin­i­cal tri­als and the Cana­dian Cancer So­ci­ety is a ma­jor con­trib­u­tor to sig­nif­i­cant re­search to im­prove the qual­ity of life for peo­ple with cancer.

Clin­i­cal tri­als al­low spe­cial­ists to care­fully study a promis­ing treat­ment or a sus­pected link between cancer and a sub­stance or be­hav­iour. Cancer treat­ments may show pos­i­tive re­sults in lab tests or in small groups of peo­ple, but re­searchers have to show that th­ese treat­ments are safe and work well in a large group of peo­ple be­fore Health Canada will ap­prove them.

Health Canada has strict con­trols and reg­u­la­tions to keep peo­ple safe – and in some cases th­ese rules are dif­fer­ent than in other coun­tries so if you hear about a new drug or promis­ing treat­ment don’t as­sume it is also avail­able in Canada.

You may be ex­pected to com­plete an ini­tial screen­ing in­clud­ing a multi-page ques­tion­naire or spe­cific tests, and you will be asked to sign a re­lease form to be in­cluded in a trial. You may be asked to sign a con­fi­den­tial­ity agree­ment or to agree to the pri­vacy pol­icy of the clinic or lab.

Some peo­ple be­lieve that by en­ter­ing a trial they will get free med­i­ca­tion. That may be true, but it may also be that you re­ceive a “placebo” or drug with­out an ac­tive sub­stance. This is to elim­i­nate as many vari­ables as pos­si­ble to eval­u­ate whether or not the med­i­ca­tion or treat­ment is ef­fec­tive. It is im­por­tant for re­searchers to know that any changes are due to the ac­tual ef­fects of the drug and not ex­pec­ta­tions, hopes or imag­in­ings of par­tic­i­pants.

Be­fore you de­cide to en­ter a clin­i­cal trial, you need to con­sider the ben­e­fits or risks and how your par­tic­i­pa­tion may af­fect your qual­ity of life. There are ben­e­fits to you if you qual­ify and en­rol – such as ac­cess to new med­i­ca­tions and close mon­i­tor­ing by pro­fes­sion­als but ben­e­fits might not be ap­par­ent im­me­di­ately and may not even be per­sonal. Some trial par­tic­i­pants view their role as help­ing oth­ers in the fu­ture as sci­en­tists learn more about the dis­ease, treat­ments and out­comes.

Just be­cause you par­tic­i­pate in a trial there is no guar­an­tee that you have ac­cess to the med­i­ca­tion af­ter com­ple­tion be­cause it may still take years for the drug to be ap­proved for the gen­eral pub­lic. You may have to travel to a cen­tral lo­ca­tion for ap­point­ments and your qual­ity of life might be af­fected at least tem­po­rar­ily. It will be cru­cial that you fol­low the pro­to­col (ac­tion plan) ex­actly as pre­scribed. If you don’t or if you sup­ple­ment the med­i­ca­tion with other drugs, the re­sults could af­fect the out­come and lead to faulty con­clu­sions.

There are many ques­tions to ask be­fore you agree to join a clin­i­cal trial and your med­i­cal team will be ready to re­as­sure you. You should ask about the na­ture of the study, the length of it, what you can ex­pect, and what is ex­pected of you dur­ing and af­ter the study. You will want to know about pos­si­ble dis­com­fort, life style changes and ex­penses while par­tic­i­pat­ing in the trial. Pre-plan your ques­tions us­ing the guide on the Cana­dian Cancer So­ci­ety web­site (www. cancer.ca) and be ready to ask any oth­ers that come up dur­ing your con­sul­ta­tion.

If you have cancer and are in­ter­ested in be­ing con­sid­ered for a clin­i­cal trial, con­sult your doc­tor, or in­ves­ti­gate on your own through the Cana­dian Cancer So­ci­ety or other rep­utable on­line re­source.

If you want to know more about clin­i­cal tri­als, please talk to an in­for­ma­tion spe­cial­ist at 1-888939-3333, visit the web­site, or call the Cana­dian Cancer So­ci­ety Com­mu­nity Of­fice. Cathy Telfer is an in­for­ma­tion outreach vol­un­teer for the Cana­dian Cancer So­ci­ety in Chatham-Kent and Sar­nia-Lambton.

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