The Clinical Trial

Question 1

What are the features of Hodgkin’s Lymphoma?

Answer 1

• Lymph node biopsy in suspected lymphoma is done by Excisional Lymph Node Biopsy.
• Core biopsy can be diagnostic in some cases and can be attempted if excisional is not possible/high risk but often gives insufficient tissue to reliably diagnose lymphoma and define a subtype.
• Some types of lymphoma can look normal on FNA so false negative rate is high
• Hodgkin’s lymphoma is diagnosed by presence of Hodgkin’s cells with appropriate background milieu
• Hodgkin’s cells can be characteristic Reed-Sternberg cell or one of its variants such as lacunar cell in nodular sclerosis sub-type.

Question 2

What is the Ann Arbour Staging for Hodgkin’s Lymphoma?

Answer 2

I Single lymph node region (I) or one extra lymphatic site (I^E)
II 2 or more lymph nodes on same side of diaphragm (II) or local extra lymphatic extension, plus 1 or more lymph node regions on the same side of the diaphragm (II^E)
III Both side of diaphragm
IV Disseminated (automatic stage IV if extra-nodal involvement)
A No systemic symptoms
B Fever, night sweats, weight loss
E Extra lymphatic site, >10cm = X
S Splenic disease

Question 3

What are the requirements of the Good Clinical Practice?

Answer 3

• A set of internationally recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve people.
• In Clinical Trials of Investigational Medicinal Products (CTIMPS), UK law requires compliance with the principles of GCP described in legislation.
• Compliance with GCP is monitored and regulated by the Medicines and Healthcare Regulatory Agency (MHRA)

Question 4

What is the criteria for a healthcare professional to qualify for taking consent in a clinical trial?

Answer 4

• Ability to communicate effectively with potential participants, including explaining complex scientific/medical concepts.
• You understand the alternatives that may be available to potential participants, this may include treatment alternatives
• You understand the protocol and the potential implications it may have on the people involved
• You appreciate how to optimise the voluntary nature of decision making, avoiding undue influence.

Question 5

What is key info for a patient to know when discussing a clinical trial?

Answer 5

• They can withdraw from the trial at any time, some may require follow-up so the patient needs to be informed of this and have appropriate follow-up arranged to monitor symptoms
• Entry to the clinical trial is entirely voluntary and refusal will not affect their care in any way
• Any other info the patient considers necessary to make an informed decision - Patient Information Sheet (PIS), important that the patient doesn’t feel coerced
• Details of the trial treatment and follow-up
• The standard therapy available if they do not enter the trial

Question 6

What is the Common Terminology Criteria for Adverse Events (CTCAE)?

Answer 6

Specifically for adverse effects of drugs used in cancer therapy.

• Grade 1: asymptomatic or mild
• Grade 2: moderate and may affect instrumental ADLs e.g. shopping, using telephone
• Grade 3: severe and affecting self-care ADL, usually require hospital admission
• Grade 4: life-threatening, urgent intervention indicated
• Grade 5: death