Clinical Trials - Barriers

Indian health care continues represent unique barriers to clinical trials participation.

Most of these barriers are not recognized by health care professionals.
Purchased Referred Care (formerly called "Contracted Health Services") delays referrals to trials.
Clinical trials are not offered at most tribal / IHS / urban clinics.

Some examples of barriers to American Indians / Alaska Natives participation in clinical trials:

Patients not informed of the availability of trials
Need approvals from the Tribal / IHS Institutional Review Board and the Tribal Research Committee for a trial offered by the tribal clinic
Some Tribal Research Committees forbid taking part due to:
- Lack of resources for cancer care if the tribal member has to withdraw from the clinical trial
- Inability to use participatory research design that provides tribal Nation as an equal partner in all decisions
- Distrust of the research agency

Some believe that American Indians / Alaska Natives are guinea pigs
- But a guinea pig never has a choice and the patient does
The Community Health Representative (CHR) unable to give rides to and from the clinic for all of the required appointments
Possible problems and tribal clinic unable to help, from
- The clinical trial treatment
- Other health problems in combination with the cancer (like diabetes, high blood pressure, arthritis)
The approval of Tribal Research Committees may be needed before Natives can particpate in a clinical trial
- Example:
  - STAR was the Study of Tamoxifen and Raloxifene for the prevention of breast cancer
  - A prevention trial is for people who have not been diagnosed with cancer but may be at risk for developing a particular type of cancer
  - Cherokee Nation delayed approval of the STAR prevention trial until tribal health care providers were comfortable that there were resources available so that any women diagnosed with breast cancer would be able to access quality cancer care