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by Michel van Harten Michel van Harten | 5 Jun 2018

The Role Of Physicians In Clinical Trials And Phase 3 Medicines

Dr Michel van Harten, Head of Medical Affairs at myTomorrows, explains the role of physicians in the drug development process and after FDA/EMA approval.

Q1. Pharmaceutical companies are tasked with developing life-changing products that meet the needs of patients, physicians, and payers while adhering to regulatory standards, managing health technology. What is the role of a physician in this process?

When working with pharmaceutical companies, physicians are involved in the development of a medicine from the initial phase, in the role of investigators. Together with the pharmaceutical company, they design and perform the study. When the study is completed, the physicians analyse the results and typically write a paper explaining the study which can be published in a scientific journal.


Q2. How are physicians usually updated on the latest developments and availabilities?

There is no official or standardised way for physicians to follow the news inside the scientific and medical community, they usually read scientific journals, mainly online. In a hospital, the medical staff regularly organizes scientific meetings where they update each other on the most recent developments in their field of expertise.
Attending scientific meetings, both national and international, allows physicians to present and listen to the findings of studies.


Q3. From a physician’s point of view, how relevant is a Phase 3 trial? (Eg. Is it easier to suggest a medicine in development when in phase 3?)

When a medicine reaches phase 3, it is at its final stage after having passed two other phases. This means that there is already some established evidence that the medicine is safe and possibly effective. The chance that a patient would benefit from this trial – if not included into the placebo control group - is therefore higher than in phase 2. Including patients into a phase 3 trial is important also for the sake of science: if phase III is completed and successful, a new medicine can enter the market earlier.

In parallel to a phase 3 study, there is a possibility for the pharmaceutical company to set up an Early Access Program (EAP). When a patient is not eligible for a clinical trial – for whatever specific reason – the patient can be included into an EAP. Depending on the country, the authority will assess whether the available safety and efficacy data, collected in an earlier phase, is good enough to treat the patient.


Q4. And how relevant is the approval from a government agency as FDA or EMA?

It is of course very relevant: the approval by authorities means that the medicine is found to be safe and effective, therefore can be offered as a treatment option.
If the FDA (Food and Drug Administration in the US) or EMA (European Medicines Agency in Europe) approves the medicine, and there is an agreement on nationally reimbursed price, physicians can start prescribing the new medicine.


Q5. After FDA or EMA approval, is it easy for a physician to prescribe such a medicine?

Not as easy as you may think. After a government agency has approved the medicine, individual countries and insurance companies must negotiate with the

drug manufactureron the price of the medicine, and only once that all details have been settled, physicians can easily prescribe the treatment.

After market authorization, it can still take someyears before the medicine becomes widely available. Depending on the country regulations, it is possible to get earlyaccess to medicines in this stage and this is also where myTomorrows may help.