Issues specific to resource-poor settings
Enrolling participants into a trial can be challenging (both time-consuming and potentially expensive), but it can also be rewarding and, most importantly, it helps to ensure that the evidence available is relevant to patients like yours.
One way to gain trial experience is to participate as a site in a multicenter study.
You should consider that being a trial site places additional demands on you, your staff and resources. For instance:
- Communication with CRO (Contract Research Organization; an organization tasked by the sponsor with running the study) and Study Team, manage the electronic Case Report Forms (eCRF’s) and report Adverse Events (AEs) in English
- A computer, internet connection and access to international telephone calls
- You may need additional equipment like ECG, centrifuge, refrigerator etc., which may not be accessible at your site
- You may need access to additional laboratory, radiology, pathology and/or other tests, which may not be covered by the patient’s insurance, government and/or by the patient themselves
- You may need to administer concomitant medications, which may not be covered by patient’s insurance, government and/or by patient himself
- You may face a situation when a patient participating in the trial requires hospitalization as a result of Serious Adverse Event (SAE), and the issue of coverage of the hospital stay could arise
- You will spend a considerable amount of time beyond your regular activities
To be selected for participation you may have to:
- Ensure all trial site staff have sufficient English language skills to understand the Protocol and Investigators Brochure and Manuals, communicate with CRO and Study Team, and manage the case report forms (CRFs)
- Negotiate with CRO and/or Study Team to ensure adequate payment or in-kind reimbursement to cover your site costs.This includes (if necessary):
- adequate payment of your institution, including any required taxes, and clear methods of money transfer
- staff time, whether this is hiring new staff, or paying for the time used by existing staff
- additional staff or contractors may be required, such as: study co-ordinator, study nurse, data manager, statistician, IT manager
- laptop computer, internet access and international phone call access
- access to Good Clinical practice (GCP) training for the site staff
- required medical or laboratory equipment, which may be rented or donated
- funding for any additional laboratory tests, histopathology or radiology; this includes pregnancy tests for female participants
- funding for concomitant medications, listed in the protocol
- coverage of hospitalization in case of SAEs
- coverage of patient transport in the case of additional study clinic visits or travel to tests
Conducting your own research is time-consuming and rarely financially rewarding, but it is an essential part of improving patient care
When planning a trial in a resource-poor setting you start with less complex research, such as an observational study which does not need additional interventions and requires less regulation. Similarly, trials of screening programs utilizing diagnostic tools which are normally covered by insurance or government-sponsored healthcare can be a first step.
Interventional trials, using conventional medications, covered by insurance or government are often useful as they provide the opportunity to test your current practice or to expand the utility of currently available treatments. Finally, you may wish to participate in an interventional trial using a novel drug or product in collaboration with a pharmaceutical or biotechnology company.
Be sure to review the practical issues (listed above).
Look for collaborations
More can be done by pooling resources. In many regions, clinical trial networks – groups of sites and clinicians with an interest in clinical trials – are emerging. These networks provide shared resources, guidance and support for their members. Talk to your colleagues, search the web and social networks to see what is available – whether locally or even with the support of international collaborators.