Complexity in Clinical Trial Eligibility Criteria and Requirements

There are so many complex aspects to be considered when performing a Clinical Trial, such as the design, study, eligibility that often act as a barrier to the development of new clinical trials and the patient enrollment.

The creation of novel therapies, like molecular targeted therapies and immunotherapies came with an increase in number and complexity requirements. The rejection of potential subjects is because they do not fulfill all the specific features. This trend may hypothetically increase the scientific yield or safety of a protocol, but it also potentially hinders patient accrual, decreases study completion rates, limits generalizability and increases costs, according to García et al in the Journal of Thoracic Oncology.

Therefore, you must know where you can find the patients that you are looking for a specific protocol, so as a sponsor, you do not waste time and resources once all the involved parties have approved it.

At ALTHIAN, we have plenty experience working with complex protocols, such as lung and breast cancer protocols. We know how we can search for specific patients; and we have the fastest methods for the correct selection of the patients. For further information please contact us and we are going to be more than happy to assist you in all the process.

Reference: Garcia S, Bisen A, Yan J, Xie X-J, Ramalingam S, Schiller JH, Johnson DH,
Gerber DE, Thoracic oncology clinical trial eligibility criteria and requirements continue to increase in
number and complexity, Journal of Thoracic Oncology (2017), doi: 10.1016/j.jtho.2017.07.020.