Roche in clinical studies

Why does Roche conduct clinical studies?

Clinical studies are an essential part of developing new drugs. All new drugs must be tested in clinical studies before they can be given to patients. First, new drugs are studied in a laboratory, and if the results of the experiments suggest the drugs might work in patients, they will be carefully studied in clinical studies in people. The aim of a clinical study is to see how good a new drug is at helping people feel better, helping a disease or condition to improve or stop it getting worse. Clinical studies also test whether new drugs are safe and if they have any unwanted side effects.

What ethical principles guide clinical studies?

Clinical studies are guided by principles to ensure they are conducted ethically. They can only occur if the people organising them agree to these important rules or ‘principles’. An important document called the ‘Declaration of Helsinki’, which is produced by the World Medical Association, describes how clinical studies should be conducted ethically. Four general principles are:

• Do no harm – This is at the centre of all clinical studies because the outcome of the clinical study must be likely to provide benefit to patients without harming the individuals who are taking part in the clinical study.
• Respect for patients – This is very important and is achieved by ensuring that patients provide their ‘informed consent’. To do this, doctors should explain to the patient what the study is aiming to show, any benefits and risks involved, and how taking part in the study will affect them. Once they understand the study, a patient can decide whether they would like to take part. Another consideration of respect for patients is that all information about the patient must be kept private (or confidential) throughout the clinical study.
• Patient welfare – Researchers must have the welfare of the patient as a goal of the clinical study. They must do an assessment to measure the impact of the benefits for a patient enrolled in a clinical study compared with the impact of the risks. For a clinical study to be considered ethical there must be a clear medical need for the clinical study and evidence to justify any potential risks.
• Justice – This ensures that the processes used to choose which patients to include in a clinical study will benefit other patients in the future, include individuals who may be likely to benefit, and avoid taking advantage of vulnerable people.

The rules explained above are part of international guidelines, as well as laws in the country where the patient lives and where the clinical study is being conducted. Roche follows all of these international guidelines and national laws in their clinical studies.

Which legal and ethical standards does Roche follow for their clinical studies?
The basic right of every person is to be treated with respect as an independent moral being. The dignity, rights, safety and well-being of individuals who take part in clinical studies must be promoted and protected at all times and in any part of the world where clinical studies take place. Since people who take part in clinical research willingly provide information that cannot be obtained in any other way, they clearly deserve the gratitude and respect of the world community.

Roche is committed to following all international guidelines as well as local laws when running a clinical study. All Roche clinical studies are carried out according to the laws of the country in which the study is being done. Roche follows the ‘Guideline for Good Clinical Practice’, which is the minimum standard for all clinical studies. The Good Clinical Practice (GCP) guidelines include similar ‘rules’ for how clinical studies should be done. It defines the roles and responsibilities of clinical study sponsors (such as Roche), clinical research investigators and people whose job it is to monitor clinical studies. They also include protection of the rights of people who take part in clinical studies, and provide reassurance of the safety of the new drug and how well it works.

One important part of the Declaration of Helsinki is called ‘informed consent’. Informed consent means that information about a specific clinical study is shared by the doctor and discussed with the patient. This means that both the personal values and the well-being of the patient as well as the responsibilities of the doctor are made clear, as well as any possible risks and benefits of the research.

How is Roche’s adherence to legal and ethical standards controlled externally?
Roche respects human rights, human dignity, patient safety and ethical principles. The company is committed to act ethically, provide the highest standards of care and protect the privacy of all individuals taking part in Roche clinical studies. Consequently, Roche welcomes external control of its clinical studies, called ‘independent oversight’.

‘Independent oversight’ means qualified individuals, who are not part of Roche or the research investigator team, review planned clinical studies before the study can start. These groups approve and oversee studies involving people and are composed of researchers, ethicists, legal experts, and community members. In the US, these groups are called Institutional Review Boards (IRBs); in other parts of the world, they can be called Independent Ethics Committees (IECs) or Scientific Ethics Advisory Groups (SEAGs). This ‘independent oversight’ helps ensure the clinical research is valid and individuals taking part are protected.

How does Roche ensure that clinical studies take place according to legal and ethical standards?
All Roche employees who work on clinical studies, and contractors working with Roche, are required to strictly adhere to local laws and international guidelines, conduct their research with integrity, and apply the highest standards of medical care and respect for patients at all times. Roche employees have a duty to report any suspected issues if they think the regulatory or ethical standards are not being thought about.

Roche makes sure that Good Clinical Practice (GCP) training is given to employees working in clinical research and that employees know what to do if they have any issues. Roche has its own Scientific Ethics Advisory Group (SEAG) to help with these issues, and will either help employees find the right answer or will discuss the issues with other experts, inside or outside Roche.

There is a deep understanding of, and belief in, high ethical standards by all members of the Roche community.

What are the rights of someone involved in a clinical study?
Anyone involved in a clinical study has a right to:

• A clear informed consent process before they agree to join the clinical study, which means they understand what is involved with the clinical study and are able to decide whether they what to join the clinical study or not. During the informed consent process, patients can discuss any questions with their doctor before making their decision. Only patients who sign an Informed Consent Form after having their questions answered, can take part in the clinical study.
• Leave a clinical study at any point without giving any reasons. An Informed Consent Form is not a contract and a patient can change their decision to be involved in the clinical study.

How is the privacy of patients protected during clinical studies?
If someone decides to join a clinical study, some people will need to be told about this. These people are:

• The person’s family doctor (or primary physician) who is responsible for their healthcare on a day-to-day basis.
• The doctor and research team looking after the people in the clinical study.

After a clinical study finishes, the plan for what will be happen with any patient information is outlined in a document called the clinical study protocol, which is written before the clinical study starts. Usually this will say how long patient information must be kept before it is deleted. If any patient information is to be used, the plans for how it will be used will be included in the clinical study protocol. It will also be included either in the Informed Consent Form that the patient signs before taking part in the clinical study, or in an additional Informed Consent Form, which the patient will also be asked to sign before the information is used.

What kind of information does Roche publish on clinical studies?
When a clinical study finishes, the results are usually published in a medical journal so that doctors and scientists know what the results were. Clinical study summaries are also posted through regulatory bodies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA), and here on forpatients.roche.com.

Clinical study reports contain summaries of data and study results, but do not include any information about the identification of individual patients. Requests for anonymised patient-level data have to be approved by an independent panel of experts, who only agree if they think patients and doctors will be helped.

All of Roche’s study protocols (the plans for a study) are posted, along with the results of studies once they are completed, on two websites that are available to the public: clinicaltrials.gov and forpatients.roche.com.

What does the end of a clinical study mean for patients?
International regulations and laws require that patient records from clinical studies are stored for a certain period of time (for example, 15 years or more). Even when a clinical study has ended, patient records will be kept private and not shared with people outside of the clinical study.

As part of the international guidelines, Roche allows patients to continue the treatment they were taking during the clinical study if it is appropriate. However, if someone is receiving a new drug as part of the study, it may not always be possible for them to continue the new drug when the study ends. If the new drug was found to work, it can take some time for the new drug to become available for people not in clinical studies, and longer again to be available for doctors to prescribe it.

Does Roche work with other companies to carry out clinical studies?
Roche will work with qualified Contract Research Organisations, also called CROs, and other types of companies whenever needed. When working on clinical studies, these other companies have to follow the same rules as Roche. In particular, the other companies will be regularly checked to make sure they are following all of Roche’s rules and guidelines. All companies that Roche works with must follow the same high ethical standards that Roche follows, and Roche employees will supervise their work carefully.

How does Roche select which hospitals/clinics will conduct their clinical studies?
Clinical studies are conducted at many different sites (for example, hospitals) and in many different countries. Using sites from all over the world helps make sure that the patients in the clinical studies are similar to patients who have the condition and are not involved in the clinical studies, but who need and could benefit from the new drug. Roche will only run clinical studies for a new drug in a specific country if there is a future plan to make the new drug available to people in that country who were not involved in the clinical study.

When selecting which sites to use for a clinical study, Roche also makes sure:

• The country/site(s) have previous experience in running clinical studies, and follow all of the rules and laws.
• Doctors and other staff who will be involved in the clinical study have relevant medical expertise, training and qualifications.
• There are enough patients being treated at the site who would be willing to be involved in the clinical study.

Are the standards for clinical studies in developing countries different?
When running clinical studies in developing countries, Roche keeps to the same high standards for these studies, as with any clinical study.

If Roche uses research results from a clinical study that is run in a low- or middle-income country, then Roche commits to apply for marketing authorisation for that new drug to be made available in the same low- or middle-income country where the clinical study was run.

In addition to clinical study conducted by Roche, there are clinical studies, called Investigator Initiated Studies, conducted by researchers that conducted by researchers that pharmaceutical companies such as Roche may choose to support.

What are Investigator Initiated Studies?

Investigator Initiated Studies (IIS) are clinical studies that are designed and run by researchers who don’t work for a pharmaceutical company. This can include individual researchers, groups of researchers, hospitals, universities or other research organisations.

Investigator Initiated Studies can help to answer important medical questions about the drugs that companies have developed, as well as the diseases that they are used to treat. The clinical studies help us to understand how best to use these drugs, which can then improve patient care. The studies may also highlight where further research is needed to find better treatments for patients.

Roche may choose to support Investigator Initiated Studies by providing Roche drugs for the clinical study. Roche may also help to fund some parts of the clinical study, for example by providing information, resources or other support. The researchers running Investigator Initiated Studies are responsible for making sure that all of the laws around running a clinical study are followed.