Nice post mate....
The lack of enrolments has been a worry so I decided to put the following to a highly respected member of the medical community.
I'm not going to mention his name for obvious reasons, but here is a little about the man to qualify his opinion. (I'm sure many of you will know who I'm talking about.)
He has had extensive commercial experience over the last 20 years in the biotech industry in project management, sales and marketing, IP management, fundraising and start-up investing. Previously, he was a Senior Lecturer within the School of Pharmacy at La Trobe University where he taught and researched in the areas of pharmacy, phage therapy, microbiology, bioinformatics and cancer.
He has a PhD from the University of New South Wales in Molecular Genetics and Biochemistry. He has more than 40 scientific publications and granted patents in molecular biology, microbiology, genetics and biochemistry.Here is the transcript of my question to him together with his response.
It may assist people in coming to terms with some of the problems associated with medical trials.
Hi XXXXX I would appreciate your input with regards the following study?
I won’t mention the stock as it is not my intention to cross promote, but to get a better understanding into the difficulties associated of with running successful trials
The Company
The company is involved in the Health Technology Sector (Medical Specialties) & engages in the research and development of non-radioactive and safe diagnostic imaging technology.
They have recently appointed a well renowned Health Oncology Research Unit to conduct their first trial. (It is one of the largest clinical trials units in Melbourne.)
I’m sure by now most have picked up both the company and the organization conducting the trial.
Two sites have already been established with a third possibly coming online in the not too distant future.
Scientific title
A Phase 1 Study Investigating the Safety and Efficacy of the XXXXXXX (Trademark) Human Epidermal Growth Factor Receptor 2 (HER2) Test Reagent Using Magnetic Resonance Imaging and the XXXXXXX (Trademark) Instrument in Subjects with HER2-positiveBreast Cancer to Test for Ipsilateral Lymph Node Involvement
Description of intervention(s) / exposure
XXXXXXXX(Trademark)Human Epidermal Growth Factor Receptor 2 (HER2) Test Reagent (MSH2TR) will bead ministered once only as a sub areolar injection (the pigmented area around the nipple) near or around the tumour; at dose of 30mg as either a single 3mLinjection or divided into 3 x 1mL injections next to each other if the volume of injection causes discomfort, after the baseline MRI and approximately 72hours prior to the scheduled biopsy. If 30mg is not tolerated by more than 2subjects in the first cohort of 6 subjects, MSH2TR will be administered at 20mgeither a single injection or divided into 2 x 1ml injections next to each other if the volume of injection causes discomfort.
Key inclusion criteria
To be eligible for study entry subjects must satisfy all of the following criteria
* Female subjects
* Written informed consent provided for participation in the study;
* In the opinion of investigator, willing and able to comply with required study procedures;
* Histologically confirmed HER2-positive primary breast cancer;
* No prior treatment for breast cancer including surgery, radiotherapy, or systemic treatment;
* In the investigator’s judgment from previous clinical, pathological, or imaging evidence have a likelihood of having at least 1 lymph node metastasis;
* Scheduled for surgical intervention with a SLNB and/or ALND as guided bytechnetium-99m (99mTc) diagnostic agent injection procedure being part of the surgical plan, or scheduled for a core biopsy of a node that is clinically suspicious, or have already had a lymph node biopsy and are willing to have a second core biopsy;
* A female subject who is not pregnant or breastfeeding,
Date of first participant enrolment
Anticipated1/03/2021
To date there have been no enrolments from either site for this trial.
- Is there a fear factor associated with a trial of this nature?
- Would a cash incentive be an option to attract participants?
- Should the company be looking to stage this type of trial offshore?
ResponseI most certainly know which company this is and they will have an uphill struggle with recruitment here in Australia.
The basic problem they have is they are developing a diagnostic that requires the participants to undergo quite an extensive set of invasive medical procedures.
These might help diagnose the cancer better, but it is not going to help the patient’s treatment directly.
You can’t for ethical reasons pay the volunteers more than just reimbursement for their costs. I know this seem silly, but those are the rules of clinical research.
If I was running the company I would be looking to go offshore for the Phase 1.
Yes you will lose the R&D tax rebate, but at least you will be able to recruit patients.
I sincerely hope this will give a better understanding to some of the pitfalls associated with conducting a trial of this nature.
(20min delay)