We develop ophthalmology, i.e. international clinical trials

With extensive experience of the medical staff and cutting-edge diagnostic base, OCHO conducts phase II, III and IV clinical trials, aiming at finding the most effective therapeutic paths in ophthalmology.

The effects of work performed by the Team of Investigators formed at OCHO by specialist doctors, nurses and task coordinators, enable development of innovative treatment methods and are an important element of international cooperation of the scientific ophthalmological environment. Clinical trials with the participation of patients are conducted with observance of the highest standards of safety, in accordance with the guidelines of Good Clinical Practice (ICH GCP).

Stages of clinical trials

Moving to subsequent levels of trials is conditioned by achieving positive results of each of ongoing stages. During the whole research cycle, patient welfare and ensuring maximum protection of patient rights is a priority.

Phase I of clinical trials involves safety assessment of the study drug/substance.

A group of several dozen healthy volunteers is enrolled to study metabolism, absorption, excretion, possible toxicity and interactions with other received substances, food and medications. After completion of this stage, it is possible to determine the amount and dosage of the study substance. Trials take place at specialist sites, which frequently belong to pharmaceutical companies or research institutions.

Phase II of clinical trials involves assessment of the study drug efficacy in a predetermined group of patients, and the level of safety for the patients.

The assessment includes a correlation between the dose and potential effect of the study drug, which results in determination of an adequate dose of the substance to be used in subsequent trial phases. During the entire stage two, the study drug is assessed with regard to its safety; a detailed analysis is applied to data on absorption, metabolism and excretion of the drug, depending on sex and age. At this stage, the effect of the new drug is compared either with placebo or with the drug used so far in the treatment of a specific disease entity. Comparisons are made with the use of “blinded” method, which ensures the most objective assessment of the effect. In practice, this means that neither the patient nor the investigator knows if the patient receives the study substance or placebo. The group participating in this stage is randomised and includes several hundred volunteers, including especially those with the diagnosed disease entity for which methods of effective therapy are searched. A positive assessment of Phase II is achieved when the level of benefits versus the risk of using the substance is significantly higher.

Phase III of clinical trials involves final confirmation of the efficacy of a given substance in the treatment of a specific disease entity.

The last but one stage of clinical trials involves determination of a relationship between safety of the drug and its efficacy in short- and long-term use. The studies include a group reaching a few thousand patients, and the duration is between one year and several years. Similarly to phase II, this phase also involves double-blinded methods, and random selection of patients. After positive completion of phase III, the drug may be registered and granted marketing authorisation, and the documentation related to the drug is submitted to an institution registering the medicinal product. A complete set of documents, whose contents is consulted in detail with national drug agencies, may include even several thousand pages and has to include all the data collected in the period of preclinical and clinical studies of phases I to III.

Phase IV refers to drugs already registered and marketed; its purpose is to determine the level of safety for all indications recommended by the manufacturer and for all indicated groups of patients. During the last phase, the results from previous stages are once again verified and new indications for the use of the already registered drug are prepared.

Patient participation in each stage of clinical trials is possible after detailed medical verification, and requires voluntary signing of a so called Informed Consent Form

Who can take part in clinical trials?

The conditions of taking part in a clinical trial are specified in detail by a given study protocol. The patient must meet so called inclusion criteria (e.g. age, sex, stage of the disease entity, or general health state), and at the same time must not meet any of the exclusion criteria. The above combined criteria form a basis for subject verification and their potential participation in the conducted studies.

During the qualification for the trials, the doctor is obliged to answer all patient questions and doubts, and to provide them with the information necessary to take an informed decision about the participation in the research process and signing an Informed Consent Form.

Also, the patient has a right to resign from taking part in the studies, and may withdraw from participation at any time, without giving any reasons. After withdrawing his/her consent, the patient has a right for a follow-up visit and evaluation of their current health state.

Each process takes place in accordance with applicable laws, including especially the provisions of the Pharmaceutical Law Act of 6 September 2001 (consolidated text 2008, Journal of Laws No. 45, item 271, as amended), and the Regulation of the Minister of Health of 2 May 2012 on Good Clinical Practice (Journal of Laws of 2012, item 489).

Information for sponsors

OCHO Medical Group has a qualified Research Team including specialist doctors, nurses and coordinators responsible for legal procedures, logistic activities and training. We are an experienced team, conducting complex procedures of clinical trials in accordance with the principles of ICH GCP. We have the most advanced diagnostic resources and a possibility to conduct trials simultaneously at our ophthalmological centres in Rzeszów, Nałęczów, Lublin, Kraków and Nowy Sącz.


Stage 1

Sponsor/CRO request directed to OCHO Medical Group is assessed by the Team of Investigators with regard to a possibility of conducting trials at OCHO centres and to obtain an opinion of a particular Investigator interested in conducting clinical trials (process feasibility).

Stage 2

After making positive decisions, the stage of contracting studies is initiated, which requires submission of the following documents: clinical study protocol, summary of clinical study protocol in Polish, a policy copy or another document confirming a civil liability insurance contract between the Sponsor and the Principal Investigator, a draft clinical trial agreement.

Stage 3

Prior to signing an agreement, the Sponsor/CRO is obliged to submit: consent of the Bioethics Committee to conduct the trial, a copy of the current National Court Register entry or a certificate of the entry into the register of business activity of the party commissioning the clinical trial, power of attorney for subjects representing the party commissioning the clinical trial.

Stage 4

The basis for conducting clinical trials at OCHO is signing a trilateral agreement between the Sponsor/CRO, Investigator and the selected OCHO centre.

Stage 5

The Sponsor/CRO submits a draft clinical trial agreement in an electronic version; the agreement may be bilingual, wherein the Polish version is binding in the event of potential disputes. The agreement is subject to the provisions and interpretation under the Polish law.

Stage 6

The stage of negotiating the terms and conditions of the agreement takes place in the form of electronic correspondence, and remarks to the draft of the agreement are made in the tracked changes version.

OCHO Medical Group makes every effort to perform the process of contracting new agreements within the shortest time possible and to make it an effect of settlements satisfactory for all interested parties.

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