Issues specific to resource-limited settings

One way to gain trial experience is to participate as a site in a multicenter study.

General considerations

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

Practical issues

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-limited 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.

• The WHO TDR group aims to help researchers in low- and middle-income countries build capacity, provides links to training and fellowships and programs supporting women in scientific research. Their strategic review is also available and highlights some important challenges .
• The Nuffield Council on Bioethics provides an in-depth review of the issues surrounding ethical practice of human research in resource-poor areas.
• The University of Oxford has a series of podcasts relating to research in low and middle income countries presented by researchers from Kenya and Thailand.
• Field Trials of Health Interventions from International Epidemiological Association\Resources\Publications contains detailed advice on trial design, planning and analysis that is relevant to all resource levels.
• Implementation Research Toolkit [although aimed at implementation research rather than randomized trials, this toolkit contains much useful information about research in low-resource countries; produced by WHO Special Programme for Research and Training in Tropical Diseases]
• Global Health Trials [developed by a collaboration between many research organisations that work in the field of global health aiming to facilitate contact between those working on trials in resource limited settings. It is open access and free. Contains many useful resources]
• ICH website [includes ICH Good Clinical Practice guidelines and ICH Members and Observers]
• Handbook for good clinical research practice (‎GCP)‎ : guidance for implementation [WHO-GCP]
• Clinical Trial Planning [includes useful templates and advice for trial sites and for trial design; Oxford University Hospitals]
• Toolkit and Educational Materials [from the US NIH Institute of Dental and Craniofacial Research]
• UC Davis Clinical Research Guidebook [contains useful timeline and other resources]
• Global Health Training Centre