Clinical Trials

Clinical trials are research studies performed in people that aim to evaluate a medial, surgical or behavioral intervention.

What is a Clinical Trial?

What is a Clinical Trial?

Clinical oncology

"We have conducted many trials at PharmaMar, as we are motivated to offer hope to patients with unmet medical needs, including in rare diseases."

Carmen Kahatt

Senior Manager, Clinical Oncology

WHAT ARE THE BENEFITS OF CLINICAL TRIALS?

Outcome driven clinical trials

We have conducted many clinical trials at PharmaMar, as we are motivated to offer hope to people with unmet medical needs.

Why do people enter in clinical trials?

Entry into a clinical trial is entirely voluntary and can be withdrawn at any time for any reason. Participants may find out about and have access to new treatments before they are widely available.

Many people say participating in a clinical trial is a way to play a more active role in their own health care. Other people say they want to leave a legacy to humanity by contributing to medical advancements.

What are the risks of a clinical trial?

Clinical trials test out medicines that are not yet approved in a certain indication. As such there are risks that the medicine may not work, or may generate unwanted or unexpected toxicities. Because the medicine is not yet available to the general public and has not gotten regulatory acceptance, there is a smaller database of information on which to rely on than for approved medicines.

Many clinical trials will compare a new medicine to an older one or to a placebo and neither the enrollee nor their physician may know which they are getting.  All of these issues should be discussed with your physician to see if the trial is suitable for you and your circumstances.

How do I find out about clinical trials?

Ask your healthcare professional about clinical trials that may be of interest to you. Only they can decide if they believe they are appropriate.

What happens if I change my mind?

Entry and continued enrollment in a clinical trial is entirely voluntary and the involvement can stop at any time for any reason. We’re here to help.

Science, not impressions

Performing basic research
Establishing a hypothesis, testing the hypothesis by carrying out experiments or collecting observations based on those predictions.

A hypothesis is a conjecture,
Determine if the hypothesis was correct, and they are conducted under the auspices of the relevant healthcare authorities to ensure appropriate standards of patient care and safety.

Ali Zeaiter M.D., Director, Clinical Development

Science, not impressions

The different phases of clinical trials

Clinical trials usually advance through three phases called Phase I, II or III, to test a treatment, find the appropriate dosage, and look for side effects.

Phase I

Phase II

Phase III

Phase l trials of a new drug are the first that involve people. Phase I trials are small studies done to define the highest dose that can be administered safely without causing severe side effects. These studies also help to decide on the best way and regimen for the application of the new treatment.

In Phase II studies, a larger group of patients with a particular disease receive the drug to initially assess its effectiveness and to further study its safety. If enough patients benefit from the treatment, and the side effects are tolerable, Phase III clinical trials can begin.

Phase III studies typically involve many more participants from the population for which the medicine is intended to be used. Phase lll clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment. When Phase III clinical trials (or sometimes Phase II trials) show that a new drug is more effective or safer than the current treatment, a drug application is submitted to Health Authorities for approval.

Phase I

Phase l trials of a new drug are the first that involve people. Phase I trials are small studies done to define the highest dose that can be administered safely without causing severe side effects. These studies also help to decide on the best way and regimen for the application of the new treatment.

Phase II

In Phase II studies, a larger group of patients with a particular disease receive the drug to initially assess its effectiveness and to further study its safety. If enough patients benefit from the treatment, and the side effects are tolerable, Phase III clinical trials can begin.

Phase III

Phase III studies typically involve many more participants from the population for which the medicine is intended to be used. Phase lll clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment. When Phase III clinical trials (or sometimes Phase II trials) show that a new drug is more effective or safer than the current treatment, a drug application is submitted to Health Authorities for approval.

Our investigational medicines

Looking to access

In certain circumstances, pharmaceutical companies with the agreement of relevant healthcare authorities can make a medicine available prior to its approval. This is usually limited to where the condition is an unmet medical need. These programs are called ‘compassionate use’ or ‘expanded access’. For example, our current compassionate use program has enrolled over 2,500 patients from all over the globe. Please consult with your healthcare professional to be informed whether such a program exists and it would be suitable for you or not as well as whether such a program exists in your location. Alternatively, they can email either compassionateuse@pharmamar.com for oncology or compassionateuse-virology@pharmamar.com for virology, stating your interest and country of residence. The enquiry must come from a healthcare professional.

Open Clinical Trials

Speak to your physician if you are interested in learning about a clinical trial

Lurbinectedin

Pharmacokinetic Study of PM01183 in Combination With Irinotecan in Patients With Selected Solid Tumors

Learn more

Plitidepsin

Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection (NEPTUNO)

Learn more

ETHICS AND LEGAL

We are ruled by principles

HOPE & RESPONSIBILITY

We are motivated to offer hope to patients with unmet medical needs, including in rare disease, and are accountable to patients as well as ourselves to deliver on this.

UNIQUE

We are a unique company inspired by marine exploration for the discovery of novel medicines.

COMMITMENT

We are in an innovation business with the know-how to pursue our objectives, and the commitment to drive optimal outcomes for all our stakeholders.

RESPECT

Our company treats all our stakeholders with respect and integrity.


RIGOR

We are prepared to carry out the development of our products consistently, with rigor to the scientific process, under the dictated specifications.

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