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March 21, 2017

THE EVOLUTION OF CLINICAL TRIALS

On the first day of spring, this 2017 meeting was moderated by Zeshan Farooqui from BMS Canada and he welcomed three speakers for the evening: Dr. Elena Aminkova, PhD Interim Director of Project Facilitation Canadian Clinical Trials Coordinating Centre, Nathalie Ouimet, MSc, MBA Vice President Montreal InVivo and Dr. Tozheg Roshankar, DVM, Regional Research Manager Eli Lilly Canada Inc. and TransCelerate country lead, Canada.

As the first speaker and in the interest to set the stage regarding the evolution of Canada’s clinical trials, Elena provided a brief overview of the main advantages and challenges of doing clinical research in our country. Canada ranks 2nd in terms of competiveness vs G7 countries. Federal/provincial tax credits, regulatory speed of approvals and the top 10 pharma being in our country are some of the key advantages of pursuing clinical research in Canada. The challenges are not small, they are mostly seen in institutional overhead costs vs the non-G7 countries, delays attributable to contracts and budget approvals, loss of many clinical sites over the last 10 years, and finally Canada’s geography is seen as detrimental compared to smaller countries. Elena pointed out 3 significant reasons why Canada should hold and increase its share of clinical trials:

SPEED:

• Fast regulatory approval
• 3 months only from time trial setup to 1st patient visit
• Provincial leadership in REB efficiencies

QUALITY:

• Patient diversity/recruitment are accommodating vast therapeutic areas of trials
• World renowned researchers and institutions
• Ranks top 5 for research reputation in clinical medicine, biomedicine and overall science technology

INCENTIVES:

• R&D tax burden is the most favorable in the world; additional tax credit by provinces
• Low Canadian exchange rate
• Sustainable business environment

In order to boost clinical trials in Canada, several Pan Canadian initiatives such as CCTCC, SPOR, N2 and many others were put forward to address and improve the operation and environment for clinical trials in this country. CCTCC , which stands for ‘’Canadian Clinical Trial Coordinating Center’’, is one of many initiatives with a key objective to implement different projects with industry, government and health care institutions. The goal is to make Canada a destination of choice for clinical trials. Elena provided the audience with examples of different initiatives developed by CCTCC:

1. CCTAM: Canadian Clinical Trial Asset Map
   • Web based living, easily searchable, interactive Canadian database with research capabilities in investigators, clinical research sites – Hospitals – REB, etc.
2. Patient Registries:
   • Populating in the CCTAM to facilitate clinical trial feasibility studies and patient recruitment
3. mCTA : Model Clinical Trial Agreement:
   • Initiative meant to standardize clinical trial agreements and contract negotiations
4. Fair Market Value Project (FMV)
   • Initiative meant to introduce resource’s/best practices and provincial solutions to reduce clinical trial budget negotiation times

As the second speaker, Nathalie Ouimet, of Montreal InVivo presented key and specific initiatives that were developed by the company in order to increase the contribution of Quebec in the clinical landscape. From 2008-2014, phase 0-2 clinical trials have shown a decrease of 38% compared to 50% when compared to the rest of Canada. Due to the loss of clinical trials in Québec, InVivo was looking at where to position themselves in order to maximize economic benefits. Competing against China or India was surely not the solution. Early stage clinical trials were chosen since Montreal could be recognized as an effective and efficient world-class reference of expertise while improving business environment so that research excellence could flourish and attract more private investments. InVivo participated in the following Quebec initiatives:

EXACTIS Innovation

• InVivo dispensed funds to provide additional research coordinators to help investigators with the early start and progression of their clinical trials and also to better match specific types of tumors and recruitment of patients

MHICC: Academic CRO

• The Montreal Heart Institute leads many studies and their reputation is recognized world-wide. Large efforts have been put in building an atherosclerosis imaging network which is very important as a reference background when doing clinical trials. 30,000 patients are part of a bio-bank for genetic research.

C3I: Centre for Commercialization of Cancer Immunotherapy

• Hôpital Maisonneuve Rosemont has the largest stem cell transplant center in Canada and is therefore a top choice for clinical studies in immunotherapy.

Research Initiative on Rare and Genetic Disease in Adults

• IRCM carries out clinical research on rare and genetic diseases in adults. Some clinical studies are done in children and this initiative was put forward to gain a better understanding on the adult population.

The 3^rd and last speaker of the evening was Dr Tozheg Roshankar, Regional Research Manager Medicines Development Unit, at Eli Lilly and Country lead for Canada TransCelerate.

TransCelerate Biopharma Inc. is a non-profit organization with a mission to collaborate across the biopharmaceutical research and development community to identify, prioritize, design and facilitate the implementation of solutions to drive efficient, effective and high-quality delivery of new medicines to improve the health of people around the world. Before presenting some of the key initiatives developed by TransCelerate, Tozheg asked everyone to see them as a framework/solution designed in a collaborative manner to respond to a problem initially identified.

One of the 5 key strategic priorities in selecting new initiatives is improving the patient experience with clinical trials. Clinical trial sponsors are encountering difficulties with identification, recruiting and retaining patients. The same applies to patients trying to find meaningful clinical trial experience. TransCelerate have created several initiatives focusing on enabling a more informed and aware patient while at the same time decreasing the patient’s burden and promoting new technology.

Patient Initiatives

• Clinical Research awareness: aimed at providing more accurate information and details to the general public relating to clinical research
• Clinical Research Access & Information Exchange: Improve availability of meaningful information on clinical trial opportunities and create a reliable source of information
• Patient Experience: aimed at enabling patient engagement and value realization in clinical trials through patient centric trial design and execution. Understanding the patient perspective is crucial when designing a clinical protocol.
• Patient technology: aimed at using technology as tools to help and support patients in clinical trials. IPADS are currently being used in many trials for patient assessment which historically had to be done at the HCP office. Other technologies are being studied to capture patient metrics remotely.
• eConsent: aimed at transforming the hazardous process of traditional consent by using an array of patient focused multi-media components to empower patients to make informed decisions about the consent. PSP are requiring informed consent. Could this initiative be helpful in patient enrolment
• eLabels: aimed at helping the industry on the journey to digitally supported patient-centric clinical supply chains. This is viewed as a possible toolkit to facilitate external engagement and uptake in the industry
• Common Protocol Template: aimed at creating a common template in order to ease interpretation and enable downstream.

In conclusion all 3 speakers hoped and felt that with the new initiatives put forward, clinical research in Canada could be reinstated at the level where it deserves.

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Jo-Ann Charland
Training Consultant and Medical Writer
Email: JoAnn.Charland1@gmail.com
Cell: 438-998-0498
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