Barriers to Participation and Enrollment »
Cost/Lack of insurance. In clinical trials in the US, costs associated with treatments that
are part of standard of care are usually—but not always—covered by health insurance
companies. Coverage depends upon laws within individual states and policies of
individual providers. Research costs, which are the costs associated with investigational
treatments or evaluations, are often not covered by health insurance companies and must
be covered by the company sponsoring the trial. This increased cost to the sponsoring
company may lead to selection of different trial sites or patients for study participation.
Lack of health insurance is a barrier to participating in clinical studies for patients in
the US. A study of NCI-sponsored cancer treatment trials found that uninsured patients
A study of NCI-sponsored
cancer treatment trials
found that uninsured
patients represented
only 5.4 %
of all clinical
trial participants
(Sateren et al, 2002)
represented only 5.4% of all clinical trial participants.5
For patients with health insurance, barriers still exist. Some insurance companies only
cover participation in clinical studies where the efficacy of a treatment is evaluated.
Oftentimes phase I studies focus on issues related to the safety and tolerability of
BUT barriers still exist
for patients with
health insurance.
a medicine rather than efficacy, making them unqualified for coverage. Even in
interventional trials patients can be denied coverage for participation.6 The Patient
Protection and Affordable Care Act (PPACA), enacted by Congress in March 2010, requires
health insurers to provide coverage for routine patient care costs for patients taking part
in federally funded or approved cancer clinical trials.1 These requirements apply to plans
or coverage sold after 2013 and do not apply to those initiated before the PPACA was
enacted. Therefore, it may be some time before the act causes changes in enrollment in
oncology clinical trials.
Figure 3. Barriers
to Participation and Enrollment
clinipace.com
2