Contacts

FAQ

How do I get information about clinical trials sponsored by MolMed?
Patients, their relatives or anyone interested can obtain information on clinical trials sponsored by MolMed by browsing this website and by checking either the website of the Italian Drug Agency or ClinicalTrials.gov, which collect information on trials conducted in Italy and worldwide, respectively. Information provided includes all the centres participating in each trial which can be contacted directly. For further details, you can contact the Clinical Development Department at MolMed through the form provided.

What is the meaning of Phase I, Phase II or Phase II clinical trial?
Phase I clinical trials are the first trials of a new drug candidate in humans, with the aim of providing a preliminary assessment of safety and a first profile of its pharmacological activity in humans. Phase II clinical trials are therapeutic pilot studies aimed at demonstrating the clinical activity and evaluating the safety of a drug candidate in patients affected by the disease for which the experimental drug is proposed as a new therapeutic option.
These trials are conducted on a limited number of subjects; at a more advanced stage, they often imply a comparison with other drugs or a placebo. Lastly, Phase III clinical trials are conducted on larger patient populations to compare the effect of the investigational new drug  versus the standard treatment used in clinical practice, or versus a placebo. Phase III trials are usually double-blind randomised trials. In this last investigational stage, performance and characteristics of the most frequent adverse reactions must be investigated, and properties of the experimental drug must be examined, such as clinically significant interactions with other drugs and patients’ response based on factors such as age or sex.

What is the informed consent?
It is a procedure whereby a person voluntarily agrees to participate in a specific clinical trial, after being informed in an understandable way about all aspects of the trial relevant to his decision. Informed consent is documented by a specific form completed, signed and dated.

What happens when a person agrees to participate in a clinical trial?
When a person agrees to participate in a clinical trial and signs the informed consent, he or she will undergo an initial screening in order to verify whether his/her general health conditions and the stage of the disease meet the eligibility criteria for inclusion in the trial.

How long is an investigational treatment in a trial?
Duration of an experimental treatment depends on the design of the trial, which beforehand defines the factors leading to interruption of the therapy. These generally include relapse or progression of the disease, severe side effects or the decision of the physician in charge of the trial; in any event, the patient will be free to withdraw from the trial at any time.

What is the meaning of randomised trial?
A randomised trial is a trial where each patient is assigned either to an experimental treatment group or control group according to a purely random statistical criterion that cannot be influenced by the physician, in order to reduce bias.

What is the meaning of controlled trial?
A controlled trial is a trial that includes a control group, in which the control group receives either other drugs or a placebo.

What is the meaning of blind trial?
A blind trial is a trial with concealed aspects, a procedure whereby one or more parties involved in the trial are kept unaware of the kind of treatment assigned to the patient. In a “single-blind” trial, the assignment either to the treatment group or to the control group is unknown only to the patient, while in a "double-blind" trial neither the patient nor the physician know what kind of treatment is given to the patient until the end of the trial. If it proves necessary, information on the treatment received can be traced and provided immediately. This methodology is needed to obtain valid results without leading to an increased risk.

What is the meaning of open label trial?
An open label trial is a trial without a control group, as opposed to a controlled trial. It also indicates a trial with no concealed aspects, as opposed to a blind trial.

What is the meaning of placebo?
A placebo is a pharmaceutical preparation with no active ingredient and consisting only of excipients (therapeutically inactive substances added to a medicine to facilitate administration), which is identical in appearance to the active comparator drug.

What is the meaning of Progression Free Survival - PFS?
Progression Free Survival is the time period in which the disease does not progress; it is the time elapsed between the date of randomisation in the trial to the date of disease progression confirmed by a CT scan or MRI (magnetic resonance imaging).

What is the meaning of Disease Free Survival - DFS?
Disease Free Survival is the time period in which the patient does not have the disease; it is the time elapsed between the date of randomisation in the trial and the date the disease reappears.

What is the meaning of Conditional Marketing Authorisation?
The Conditional Marketing Authorisation represents an expedite path for early market authorisation ahead of completion of the pivotal registration studies. Such anticipated authorisation is mainly based on efficacy and safety evidences accumulated in early studies. A Conditional Marketing Authorisation may be granted only if all the following requirements are met: 1. the risk - benefit balance of the medicinal product is positive; 2. it is likely that the applicant will be in a position to provide the comprehensive clinical data; 3. unmet medical needs will be fulfilled; 4. the benefit to public health of the immediate availability on the market of the medicinal product concerned outweights the risk inherent in the fact that additional data are still required. 

What is the meaning of Fast Track?
The Fast Track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose of the Fast Track designation is to make important new drugs available to the patient early. Actually the Fast Track program enables a company to submit sections of the NDA on a rolling basis as data becomes available rather than waiting until every section of the application is completed, as usually happens with a regular NDA. A drug program with Fast Track designation enables the company to have early and frequent communication with the FDA in the development and review of the product candidate.

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