Protecting Patient Safety

All medicines are subject to rigorous testing before they are approved by regulatory authorities (such as the US Food and Drug Administration, the EMA for EU and local agencies from other countries). Before a medicine is given to patients, findings from early laboratory studies are carefully analysed by Roche scientists and discussed with regulatory authorities. The medicine then undergoes a monitored process of investigation using well-designed and controlled clinical trials. Controlled trials are those which compare the new medicine to a placebo or existing medicines. They are usually “double blind” so that neither the patient nor the doctor knows which medicine the patient is receiving. This ensures the results are not biased. These studies gather information about the efficacy and safety (e.g. side effects) of new medicines compared to existing treatments. In addition, information is gathered by studying different patient populations (e.g. young, elderly, gender), different dosages and the use of a drug in combination with other medicines to see which patients benefit the most or have side effects.

We have robust global systems in place to continuously monitor the safety of a drug, from the time it is evaluated in clinical studies to the end of its life on the market. This process includes:

• a proactive safety management plan supported by qualified physicians who monitor overall safety

• risk management plans reviewed and approved by regulatory authorities

• product recall procedure to ensure that we can withdraw products quickly, if a quality or safety problem arises

We also review various databases, including our own global database, other safety databases and large patient healthcare databases to help us spot potential safety risks. This includes regular review of published literature in the area and other publications on similar products (e.g. same class or same mode of action).

Roche’s Safety Risk Management Department systematically monitors all Roche drugs worldwide — both before and after they are launched. Whenever a new adverse event is identified which may have causal association to the Roche product, we evaluate all available data and work with the health authorities to update the product labelling as appropriate.

Where required, we prepare risk management plans that we submit to health authorities in compliance with national and international regulations. In preparing these plans, we ask a wide range of questions to help us effectively manage the possible risks related to using our medicines. These include:

• What do we know about the medicine, what are its known and potential risks?

• What don’t we know and how do we want to get information to learn more about the safety of the medicine?

• Which patients should be prescribed the medicine?

• Which patients should not be prescribed the medicine?

• What should people avoid when taking the medicine, for example, other medicines, certain foods, alcohol, etc.?

• How do we plan to protect patients from risks or plan to manage the risks to keep them within acceptable level?

• How do we plan to communicate risks to healthcare professionals and patients?

Diagnosis and therapy go hand in hand. Our diagnostic tests are used to diagnose the illness and determine disease status, monitor the effectiveness of treatment, and detect relapse. In addition, during drug development, they can be used to identify new therapeutic targets for drug discovery, screen out unpromising drug candidates, or can be used to select patients who are most likely to benefit from a treatment.

With the right use of diagnostic tests, the safety and efficacy of the medication can be improved by making sure that the right patient receives the right medication. Today, every drug being developed at Roche has a diagnostics programme associated with it to help drive towards developing personalised healthcare solutions.

Our drug safety team’s responsibility is to appropriately monitor the safety of the products and to process incoming safety information and to report this to Health Authorities, based on local regulations. All new safety information events are reviewed and analysed as soon as possible and classified in terms of their severity and the possible causal association to the Roche product.

In addition, it is the responsibility of all Roche employees, and contractors to Roche, who become aware of an adverse event involving a Roche product to report the potential adverse event as soon as possible (within one business day). Employees undergo an intensive training on what is an adverse event, how to recognise one and how to report adverse events.

Our Drug Safety Committee is responsible for drug safety governance. The committee reviews drug safety information on a regular basis and decides on the best course of action to communicate and to mitigate risks as appropriate.

Clinical trials are critical for determining the safety and efficacy of new medicines and the clinical value of diagnostic tests. They also help to determine the cost-effectiveness of a treatment or diagnostic test and how a treatment improves quality of life. Roche places a high priority on communicating information about studies that are currently enrolling as well as on ensuring that clinical trial results for completed studies are publicly available to physicians and other interested parties.

We provide information about all Roche-sponsored trials through a clinical trial protocol registry published on www.roche-trials.com, which includes a database of key results from completed trials, regardless of the outcome. Details of Roche clinical trials are also posted on the US National Institutes of Health global registry Clinicaltrials.gov.

We share this information with regulatory authorities and payers in order to gain marketing approval and, ultimately, reimbursement. We also publish the results of our clinical trials, both positive and negative, in various medical and professional journals to inform healthcare professionals, researchers, patients and the public about potential new therapies under development. By learning from individual setbacks, researchers continue to look for ways to improve the clinical trials process in order to speed the delivery of safe and effective new medicines to patients, and to encourage innovation.

Around 320,000 people worldwide participate in our clinical trials each year, in over 35,000 participating medical centres, where they receive standard-of-care treatment and potential access to our investigational medicines.

A potential new medicine undergoes a thorough process of investigation. Using carefully well-designed clinical trials, we gather and study information about the efficacy and safety of a new medicine.

During each phase of the clinical trials, the safety of the medicine is thoroughly investigated through considering all emerging data by a number of cross-functional teams. Their role is to assess the overall effectiveness and the safety of the product and hence determine its benefit–risk profile.

In a controlled trial, we compare the new medicine to a placebo or existing medicines. These trials are usually “double blind.” That means neither the patient nor the doctor knows which medicine the patient is receiving. This ensures that the results are not biased.

We also gather valuable information by studying different patient groups (e.g. young, elderly), different dosages and the use of a drug in combination with other medicines. The goal is to see which patients benefit the most or have side effects.

During each phase of a clinical trial, we evaluate the safety and efficacy of a drug candidate to determine its evolving benefit–risk profile. If the risk exceeds the patient benefit and the risk cannot be managed by acceptable measures, then we change the trial conduct or stop development of the medicine.

We also publish the results, positive as well as negative, of our clinical trials in various medical and professional journals to inform healthcare professionals, researchers, patients and the public about potential new therapies under development.

We employ a global network of drug safety staff to collect, process, evaluate and report safety information on the Roche products. Reporting any issue related to the safety or quality of our medicines is obligatory for every Roche employee becoming aware of such instances. Every adverse event report is entered in a database and assessed individually.

When a healthcare professional or patient reports an event, we take responsibility immediately by:

• following up with the reporter where necessary

• capturing the adverse event data in the Global Roche Safety Database and assessing the report in relation to the known safety profile of the product

• forwarding relevant reports to the regulatory authorities as per country-specific regulations

• evaluating any new and emerging safety information

The quality of our processes and systems are regularly audited internally and inspected by major regulatory authorities.

If you are a patient or a healthcare professional with a patient who has experienced a suspected side effect to a Roche medicine, please report this to us. You can report this online ator by contacting the Roche Local Safety Unit in your country. For patients, we also recommend contacting your personal physician.

Please try to include as much information as possible about the Roche medicine and the suspected side effect, including dates, reason for taking the medicine and whether the suspected side effect has resolved. If known, please also provide details of any other medication taken at the time and any medical history or allergies. All information you provide will help our ongoing monitoring of the safety of Roche products.

If we establish a causal association between our product and a reported event, we evaluate how to effectively communicate this adverse drug reaction and whether the benefits of the medicine still outweigh the risks. Depending on the circumstance and the outcome of our evaluation, we may also:

• promptly inform patients, physicians, healthcare providers and regulators of any new product safety information

• update product labelling and information with new safety information and take actions to mitigate the risk (e.g. add a contraindication to the product label or advise on measures to be taken when the adverse reaction occurs)

• write to healthcare providers with updated advice on the use of our products

If we come to the conclusion that a risk might remain for patients the product will be recalled. A recall can either be on a single batch, a series of batches or in extremely rare cases for an entire product. All medication can be identified by the batch number.

Recalls are communicated from Roche to the Health Authorities. These Roche affiliates contact whole-sellers, distributors and/or other large entities having received the affected medication, such as hospitals. In case of an immediate danger for patients, lay press and TV are informed.

Yes. We publish the results of our clinical trials externally so that healthcare professionals, researchers, patients and the public can learn about potential new therapies under development. We also present data at conferences and publish our positive and negative finding in relevant medical publications as well as the investigational brochure. By learning from individual setbacks, researchers continue to look for ways to improve the clinical trials process in order to speed the delivery of safe and effective new medicines to patients, and to encourage innovation.

Roche is committed to sharing data from clinical trials and has registered and posted summary reports for trials involving patients on, in addition to the clinical trial protocol and full set of trial results. Alongside this posting, we actively seek presentation and publication of our clinical trial data at scientific congresses and in peer-reviewed journals.

Roche announced a new policy regarding clinical trial information sharing in February 2013 expanding access to clinical study reports (CSRs) and analysable patient-level data from our trials. read more about safety and transparency in our clinical trials.

Patients are informed depending on whether the drug is in a trial phase or on the market. Before a patient has decided to participate in a clinical trial, as part of the informed consent process, the patient is informed by the responsible investigator, a medical doctor, who will inform the patient of all the risks and benefits of participating in the trial. They are also responsible for continuing to keep the patient informed of any change during the trial process,.

We work closely with regulatory authorities in preparation and managing clinical trials to develop suitable prescribing information for healthcare professionals. This includes determining the appropriate precaution or warning statements for the medicine.

When the drug is on the market, the product information clearly describes potential risks but, often, we also provide advice to reduce these risks through either package insert or educated professionals. This information helps doctors and patients to decide whether the benefits of taking a particular medicine outweigh the risks in each individual case and if specific actions are required to reduce any risk.

The most important sources for product safety information are the product label, which is available to all prescribers, and patient information which is included in the packaging of all medications. The product label and patient information must all be approved by regulatory authorities.

We submit serious adverse event report as individual case safety reports and provide periodic reports on adverse events to regulatory authorities as per local regulations

Roche responds promptly to customer complaints. If an adverse event is reported anywhere in the world, we respond immediately and effectively.