Hospitals, especially research institutes and research hospitals, are a key element of the healthcare system. They offer not only health services to patients, but also make an important contribution to the development of medical knowledge and treatment methods.
The strategic goal of the current Minister of Health in the Polish Council of Ministers is to fully use the potential of the national hospital system. The imperfections of this system result from the lack of strategic and systemic solutions concerning the role of Polish hospitals in the whole healthcare system, whose elements are not only disease prevention, diagnosis and treatment of patients, but also participation in the development of new therapeutic methods.
Organizational dilemmas of clinical trials in Poland
Medicinal substances, before they can be released for sale as medicines, must undergo clinical trials. Without active and formal participation of hospitals and research institutes, conducting such trials efficiently, on a large scale and in accordance with the scientific methodology required to verify their safety and effectiveness, is either not fully possible or significantly limited. Limited at least in terms of time and scale.
Especially in the case of clinical trials requiring highly specialized procedures, conducting them outside the hospital system requires the researcher and the sponsor to agree to numerous compromises that lower the quality of research and affect the reliability of its results. Clinical trials are often performed by investigators working in a given hospital, bypassing formal contract procedures which should include the hospital as a full participant (and participant in the total trial budget).
The exclusion of a hospital from the contracting process and the formal participation in the study is often justified by saying that this is to avoid red tape (unfortunately, the argument is not unfounded), and that the ethical and legal ambiguities are outweighed by the alleged patients’ good. Such informal use of hospital support, i.e. non-contractual use of its infrastructure and resources, means that both investigators and sponsors operate in the gray area of financial settlements as well as legal and ethical dilemmas. Preservation of this situation is of no benefit to patients, the healthcare system or hospitals. Nor, in the long run, to the investigators themselves.
Problems and ethically doubtful situations that often arise in the case of "informal" conducting of a clinical trial by investigators employed as physicians in hospitals include:
- using hospital equipment and infrastructure outside the health services system for commercial research purposes;
- using hospital human resources for commercial research purposes during their working hours paid for by the National Health Fund;
- time spent by staff and the investigator for tasks outside of the scope of their duties during business hours, already straining the already limited resources of hospitals;
- non-transparent financial settlements between the parties to the clinical trials contract, especially when the investigator acts as the entity performing the trial (i.e. study site);
- administrative, procedural and technical difficulties, if the investigator wishes to formalize relations with the hospital under the contract for conducting clinical trials;
- medical, ethical and financial responsibility for the patient in case of adverse events and the problem with the ability to react quickly and effectively;
- legal and ethical doubts related to the use of hospital patient files for the purpose of identifying and recruiting patients for clinical trials which are formally, and sometimes actually, carried out outside the hospital.
The situation in which the investigator acts as a study site, without the support of dedicated administrative and medical staff or technical infrastructure, creates additional inconveniences and risks related to the correct and timely documentation of the trial, long and often ineffective process of patient recruitment, errors in implementation of the protocol due to the informal process of conducting clinical trials by the way of daily duties.
Pharmaceutical and biotechnology companies (i.e. trials sponsors) which in this situation insist on continuing the practice of treating an investigator as a ‘study site’, act against their own interests, limiting their own organizational efficiency, shortsightedly paying attention only to the tasks at hand. They also become jointly responsible for ethically doubtful activities undertaken by investigators and expose National Health Fund, and indirectly taxpayers, to losses.
One system, a common interest
How to reconcile interests of all stakeholders of the health care system? Access to new and innovative medicines for patients requires their reimbursement by the National Health Fund which spent over PLN 11 billion for this purpose last year. It is in the interest of sponsors, policy makers and owners of medical facilities to coordinate the processes of increasing the availability of medicines (especially those refunded by the National Health Fund) and the clinical trials. This, thanks to more transparent budgeting and better financial management, will allow more effective systemic support from hospitals.
Large public hospitals in Poland, especially the research ones, can become effective participants in the clinical trials market, benefiting their own budget and all stakeholders, including particularly patients, investigators and staff, the government budget and sponsors of clinical trials - pharmaceutical and biotechnology companies.
The most important benefits to be expected in a short period of time are:
- transparent budget distribution, depending on the scope of responsibility, for all entities performing a clinical trial, including a hospital, and employees supporting the investigator,
- reimbursement of costs actually incurred by hospitals as a result of conducting a clinical trial on their premises,
- transparency in settlements, avoiding any suspicion of unethical activities.
Sponsors actively promoting clinical trials in Polish hospitals conducted on transparent budgetary and organizational principles, and thus actively funding research and development in public hospitals, would give clinical trials sponsors a stronger mandate to negotiate with the Ministry of Health higher reimbursement for the new drugs to be introduced into the Polish market.
The key elements of an efficient and modern healthcare system are:
- hospitals and research institutes with their own mission as well as technical infrastructure and human resources;
- doctors - and in the case of Institutes and clinical hospitals, the doctors who are also scientists and lecturers whose purpose is, apart from treatment, also development of medical knowledge and implementation of new treatment methods;
- pharmaceutical and biotechnology companies that provide new therapeutic substances and medical equipment;
- government Budget, taxpayers and National Health Fund representing them in our country.
The four above-mentioned pillars of the healthcare system are inextricably linked and destined to coexist in symbiosis. Participation of public hospitals and research institutes in the future healthcare system must change significantly compared to the current situation. However, in the organizational sense, hospitals and institutes seem still the weakest element in the system, requiring a major adjustments in terms of administrative and budgetary procedures before they are ready to take on a new role.
Fortunately, the case of National Institute of Geriatrics, Rheumatology and Rehabilitation in Warsaw clearly shows the direction for effective solutions. Such a solution is the creation of a separate organization within the hospital, dedicated to the acquisition, contracting, budgeting, administration and coordination of clinical trials in the hospital. Of course, it is not the name or the fact of establishing such an organization that is the solution to the problem, but the way it operates, and how it is connected with the growth strategy and budget policy of the hospital. The pillars of effective implementation of such a solution are:
- a well-planned budget system and operational controlling;
- separating medical tasks from administrative and financial ones;
- coordinating the use of hospital resources across treatment and research tasks;
- clear scope of duties of medical and administrative employees;
- specialized skillset in the administration of clinical trial processes;
- clear rules and discipline of work both in the field of therapeutic and clinical trial tasks,
- clearly stated and enforced principle of investigators not participating in projects competitive to those carried out by the hospital, as well as refraining from conducting "private" tasks, not resulting from the scope of duties on a given position or from an employer's order.
New rules of cooperation bring clear benefits for all parties. The benefits result to a large extent from the well-known economies of scale:
- for sponsors: more effective and faster recruitment, more randomized patients,
- for investigators: higher remuneration resulting from the division of duties into medical, budgetary and administrative, more randomized patients per investigator,
- for employees, including medical staff: a significant share in the budget, in exchange for the performance of tasks resulting from the allocation of duties,
- for hospitals and research institutes: additional revenues (remaining after covering costs) that can be used for investment or increasing patients’ access to health services,
- for patients: a significant increase in access to innovative therapies,
- for the government budget: weakening the pressure to increase financing in health care, more transparent and fair management of the taxpayer's money.
President & CEO in Factor Consulting, Strategic Advisor