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Affinity Clinical Research

Latest News and Information

Head and Neck study Now Open

We are excited to announce the Dynavax DV3-MEL-01 study for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) is now open to recruitment.  Head and Neck cancer includes cancer of the tongue, gum, mouth, salivary glands, tonsils, pharynx, nasal...

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Melanoma study Now Open

We are excited to announce the Dynavax DV3-MEL-01 study for metastatic or advanced melanoma is now open to recruitment (and we have already recruited our first patient!).  More information about the study can be found here. If you would to discuss this study, you can...

read more

International Clinical Trials Day 2017

Today we celebrate International Clinical Trials Day.  We would like to take this opportunity to thank all our volunteers, patients, trial participants and their families.  Without you, our wonderful researchers could not be doing the work that they do. Thank you also...

read more

International Clinical Trials Day – 20th May

On the 20th May 1747 James Lind began his trials into the cause of scurvy.  Lind's trial is recognised as one of the first clinical experiments in the history of medicine. Every year on the 20th May we pause to commemorate the work of James Lind and the countless...

read more
Happy Birthday to Us!

Happy Birthday to Us!

Today is our official first birthday and I am very excited to celebrate this milestone.  In the last twelve months, Affinity has achieved more than I could have hoped for.  Our goal at the beginning of the year was to find and initiate one study with maybe a second in...

read more
GCP Thursdays: Informed Consent

GCP Thursdays: Informed Consent

When faced with treatment decisions, it is not uncommon for patients to ask "What do you think I should do?".  This is only natural - when faced with making a difficult decision, it makes sense to ask for expert advice.  And as a health professional who wants what's...

read more
GCP Thursdays: Serious v Severe AEs

GCP Thursdays: Serious v Severe AEs

There is often a lot of confusion about the difference between a severe adverse event and a serious adverse event.  Severity is a grading.  Adverse Events (AEs) can be classified as mild, moderate or severe.  An AE can be severe without being a Serious Adverse Event....

read more

GCP Thursdays: The National Statement

If you have read the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA comments, you would be aware that Section 3 - Institutional Review Board/Independent Ethics Committee is not included.  This is because the TGA has adopted the...

read more

GCP Thursdays: Standard of Care

If someone is performing a Standard of Care procedure for a trial patient, do they need to be on the delegation log?  If the "Standard of Care" procedure does not form part of the trial, the answer is "no" and the procedure becomes part of the patient's...

read more

Head and Neck study Now Open

We are excited to announce the Dynavax DV3-MEL-01 study for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) is now open to recruitment.  Head and Neck cancer includes cancer of the tongue, gum, mouth, salivary glands, tonsils, pharynx, nasal...

read more

Melanoma study Now Open

We are excited to announce the Dynavax DV3-MEL-01 study for metastatic or advanced melanoma is now open to recruitment (and we have already recruited our first patient!).  More information about the study can be found here. If you would to discuss this study, you can...

read more

International Clinical Trials Day 2017

Today we celebrate International Clinical Trials Day.  We would like to take this opportunity to thank all our volunteers, patients, trial participants and their families.  Without you, our wonderful researchers could not be doing the work that they do. Thank you also...

read more

International Clinical Trials Day – 20th May

On the 20th May 1747 James Lind began his trials into the cause of scurvy.  Lind's trial is recognised as one of the first clinical experiments in the history of medicine. Every year on the 20th May we pause to commemorate the work of James Lind and the countless...

read more
Happy Birthday to Us!

Happy Birthday to Us!

Today is our official first birthday and I am very excited to celebrate this milestone.  In the last twelve months, Affinity has achieved more than I could have hoped for.  Our goal at the beginning of the year was to find and initiate one study with maybe a second in...

read more
GCP Thursdays: Informed Consent

GCP Thursdays: Informed Consent

When faced with treatment decisions, it is not uncommon for patients to ask "What do you think I should do?".  This is only natural - when faced with making a difficult decision, it makes sense to ask for expert advice.  And as a health professional who wants what's...

read more
GCP Thursdays: Serious v Severe AEs

GCP Thursdays: Serious v Severe AEs

There is often a lot of confusion about the difference between a severe adverse event and a serious adverse event.  Severity is a grading.  Adverse Events (AEs) can be classified as mild, moderate or severe.  An AE can be severe without being a Serious Adverse Event....

read more

GCP Thursdays: The National Statement

If you have read the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA comments, you would be aware that Section 3 - Institutional Review Board/Independent Ethics Committee is not included.  This is because the TGA has adopted the...

read more

GCP Thursdays: Standard of Care

If someone is performing a Standard of Care procedure for a trial patient, do they need to be on the delegation log?  If the "Standard of Care" procedure does not form part of the trial, the answer is "no" and the procedure becomes part of the patient's...

read more