At the Children’s Memorial Health Institute (CMHI), clinical trials of pediatric medicinal products and observational (registry) studies are carried out. The Institute has full medical and diagnostic facilities as well as highly qualified group and trained, in the knowledge of the principles of Good Clinical Practice (GCP), researchers and medical personnel. At the Institute there is a hotel facility Patron, providing hotel services. An independent Bioethics Committee is operating at the Institute, which reviews the research planned for implementation.
Fields of clinical trials/observational studies that have been carried out so far in our center:
- metabolic diseases (Gaucher disease, Fabry disease, heterozygous form of familial hypercholesterolaemia, Hunter’s disease, Niemann Pick type C disease, Morquio syndrome)
- diabetology (type 1 diabetes)
- endocrinology (growth deficit, Turner syndrome)
- gastroenterology (Crohn’s disease, functional constipation, ulcerative colitis, erosive gastro-oesophageal reflux disease, chronic hepatitis, ulcerative colitis, liver transplantation pharmaceuticals, Alagille syndrome, intrahepatica cholestasis, diarrhea caused by Clostridium difficile infection)
- immunology (primary functional deficiencies, Ataxia-Teleangiectasia syndrome)
- cardiology (pulmonary arterial hypertension, dilated cardiomyopathy, symptomatic chronic heart failure)
- nephrology (pharmacuticals used after kidney transplantation, chronic kidney disease, secondary hyperparathyroidism, hypertension, chronic kidney disease and hyperphosphatemia)
- neurology (tuberous sclerosis, giant cell subcranial astrocytoma, epilepsy, multiple sclerosis in relapsing-remitting form, Dravet syndrome, Lennox-Gastaut syndrome)
- ophthalmology (bacterial conjunctivitis)
- oncology (pharmaceuticals used for cancer chemotherapy, proliferating infantile hemangioma, glioma with high grade malignancy, medulloblastoma, solid tumors, metastatic rhabdomyosarcoma, cell no striation soft tissue sarcoma, Ewing sarcoma, primary malignant neoplasms OUN with high grade malignancy)
- urology (overactive bladder syndrome, neurogenic detrusor hyperreactivity)
The condition for the implementation of clinical trials/observational studies at the Institute is the conclusion of a tripartite cooperation agreement between the research sponsor (or its legal representative), the researcher appearing in the contract as a natural person and the Institute – Children’s Memorial Health Institute. The model of tripartite agreement for cooperation in a clinical trial proposed by the Institute is available here. It is also possible to negotiate terms of cooperation based on the model contract proposed by the sponsor.
According to the Institute’s internal procedure, the researcher selected by the sponsor should first submit to the Chief Specialist of Clinical Trials a completed application for registration of a new research at the Institute, which will be the basis to start discussions with the sponsor (sponsor’s representative) regarding possible cooperation. The application form for the registration of a new research is an internal document of the CMHI.
The following must be provided for negotiating the terms of cooperation in research:
- research protocol or its summary with a flowchart of visits (a protocol summary in the Polish language version),
- power of attorney for persons representing the sponsor to sign the contract, as well as to perform the sponsor’s activities related to the implementation of the research in the center (if applicable),
- sponsor’s proposal of the total remuneration for the center and the researcher for the implementation of study visits/procedures in relation to the implementation of visits to one participant of the research. The division of the above-mentioned remuneration is determined internally between the CMHI and the researcher.
Annexes to the contract should be:
- full version of the research protocol,
- researcher’s Brochure (if applicable),
- copy of the researcher’s and sponsor’s liability insurance for damage caused in connection with conducting a clinical trial (if applicable)
- copy of the excerpt from the National Court Register (KRS) of the sponsor and/or entity acting on its behalf or a certificate of entry in the business register, or another copy confirming the sponsor’s status (confirmed as a true copy of the original),
- declaration of the sponsor or entity performing payments on VAT on his/her behalf (if the invoice’s sponsor/recipient settles the tax in the country where the business is located outside Poland).
The Institute collects from the research sponsors an administrative fee for performing activities related the application for the implementation of the research (including revision of the protocol, preparation of cost calculation, negotiating the contract content and preparation for the research). The administration fee is a one-off payment, independent of the recruitment of patients for research, started up to 2 weeks after signing the cooperation agreement in the research, based on VAT invoice issued by the Institute.
As part of a clinical trial at the Institute, only those procedures can be performed that the Institute is able to perform on its own. The sponsor of the clinical trial should conclude a separate contract with an external service provider for the performance of audit procedures that can’t be performed directly by the CMHI.
In the Institute’s internal circuit, the process of signing cooperation agreements for the implementation of clinical trials/observational studies, as well as supervision over the proper implementation of contracts on the part of the center, is coordinated by the Chief Specialist of Clinical Trials.