TB Clinical Trial Site Capabilities
TB clinical trial sites require a number of capabilities, including well-trained physicians and nurses, experienced administrative staff, quality control, and adverse events reviewing. Laboratories also need to be equipped to carry out a wide range of tests from vital sign assessment to adrenal function tests. Initial costs of clinical trial sites can be extremely expensive, though cost-effective if properly managed.
The key source used in this study was an article published in PLoS Medicine. It is considered an authority defining the development of clinical trials and is part of the Good Clinical Practice (ICH-GCP) standards of the International Conference on Harmonization.
Medical and scientific Personnel
Medicinal personnel including physicians, nurses, field workers and regulatory experts are all required at TB clinical trial sites. In addition, scientific personnel such as ethics committee members are required, as well as biostatisticians in low-burden countries.
Both nurses and physicians need to be experienced in caring for patients with TB and must be trained in clinical research. They should be well-versed in physical examinations, including vision and neurological assessments. Theyalso should have capabilities in testing vital signs, which includes blood pressure, body temperature, weight, and heart rate. Additionally, nurses and physicians should have experience and knowledge in performing tests for thyroid function, adrenal function, urinalysis, audiometry, and coagulation (PT and aPTT). Both nurses and physicians should be able to ensure that the correct dosage of a study medication is taken.
Field workers should be employed to assure that study regimes are followed correctly. These field workers should also be available to assist with therapies as needed. Alongside this, there should be a number of regulatory experts who are well-versed in getting new compounds through the complex regulations governing the use of experimental drugs. Furthermore, an ethics committee should be available to review and approve proposals for trials.
In low-burden countries, or those counties having a low TB-incidence rate in their populations, like Canada and Australia, as examples, there is a requirement for biostatisticians with sufficient experience to be involved with trial design, data monitoring and statistical analysis. In terms of statistical analyses, staff members should be able to carry out both primary and secondary efficacy analyses, interim analyses, modified ITT population analyses, per protocol population analyses, and LOCF dataset analyses.
Laboratories and Equipment
Laboratories should be well-equipped and functional, with the capacity to carry out cultures and susceptibility testing on clinical isolates. If this is not possible, the laboratories should be able to ship clinical isolates to other laboratories for testing. Laboratories should contain equipment to perform vital signs (body weight and heart rate) testing, ECGs, hematology tests, urinalysis, audiometry, thyroid function testing, adrenal function testing and coagulation tests.
There should be administrative and logistical capabilities in the form of investigational medicinal product managers, records managers, and quality control managers to ensure that both the laboratories and the personnel at-or-above quality and safety standards and regulations.
Managers of investigational medicinal products should have specific experience in packaging and labeling, storage, returns and destruction of medicinal products, as well as knowledge of optimized background treatment regimens. Records managers should have the capacity to maintain complete and accurate confidential records. These staff members should also be involved with data collection, document sourcing, management of files and record retention at the trial site. Finally, staff trained in quality control and assurance (i.e auditing and monitoring) should be able to ensure compliance with protocol and IMP supply. They should also ensure that informed consent is provided and required documents are present.
Alongside administrative staff, there should be a data and safety monitoring board which reviews adverse events at any point deemed necessary in the study.
In summary, TB clinical trial sites require a wide range of experienced and competent staff, including well-trained physicians and nurses, field workers, and administrative staff. Additionally, the laboratories used in clinical trials should have sufficient equipment to carry out a range of tests from vital signs to thyroid functioning, as well as cultures and susceptibility testing on clinical isolates.