Written by: Gerald L. Klein, MD: Burak Pakkal, MD; Roger E. Morgan, MD; Renu Jain, PhD; Shabnam Vaezzadeh, MD; Pavle Vukojevic, MD; Larry Florin, MBA; Victoria Manax, MD

Drug Development

Canada offers advantages for conducting clinical trials within its borders, including:
- Advanced infrastructure
- High quality investigators coupled with advanced hospital facilities and research centers significantly bolsters Canada’s stature in scientific exploration
- Health Canada’s 30-day target for reviewing Clinical Trial Applications
- Health Canada also offers a 7-day review option for eligible comparative single-dose bioavailability/bioequivalence studies
- Canada has the second lowest cost among G7 nations for managing clinical trials and is ranked #1 in active clinical trials per capita [1]
FDAs Patient-Focused Drug Development defines a patient reported outcome (PRO) as a type of clinical outcome assessment used to collect patient experience data. [2] It is a measurement based on a report that comes directly from the patient about the status of a patient’s health condition without interpretation of the patient’s response by a clinician.[3]
- In oncology studies, when the PRO objective is clinical benefit, the percentage of each disposition category should be calculated using the randomized population as the fixed denominator. The PRO measure is expected to be completed by patients with various statuses such as: [4]
  - Patients who are on therapy
  - Patients who discontinue from treatment due to disease progression, adverse event, or other reasons as specified in the protocol
  - Patients who were randomized but not treated
  - Patients who paused treatment
In our opinion, it is advantageous for nursing students to be introduced to clinical research as part of their training This exposure allows them to acquire experience in comprehending and analyzing scientific literature, ultimately leading to an enhanced ability to interpret drug or device package inserts. Nurses may develop a greater understanding of pharmacokinetics, and dose range activity affecting efficacy and toxicity. Our biggest hope is that some of these students will develop a passion for clinical research and make a career of it.

Medical Affairs

The appropriate distribution of unapproved uses for approved or cleared drugs/devices has been difficult to navigate. The FDA has a new Draft Guidance: Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers. [5] This was released in October 2023 and helps to clarify many aspects of this important medical affairs area. It is strongly recommended reading for all medical affairs professions.
The importance of medical affairs (MA) in fostering the greater uptake of vaccines cannot be overstated. MA not only provides health care providers (HCP) with the latest data about their vaccines but also helpful techniques to educate their patients about the benefits of those potentially lifesaving compounds. They can help the PCP present objective information about the pros and cons of this therapy.
Small pharmaceutical companies that lack a large sales force to promote their products may be able to offset this challenging dilemma with a strong medical affairs team and a limited number of experienced medical liaisons. Coupled with an assertive digital communication plan, this approach may be able to compensate for the lack of sales force with a creative marketing and sales strategy.

https://www.investontario.ca/pharmaceuticals#clinical-trials.
21st Century Cures Act section 3001.
https://www.fda.gov/durg/development-approval-process-drugs-fda-patient-focused-drug-devvelopment-guidance-series-
enhancing-incorporation-patients-voice-medical.
Submitting Patient -Reported Outcome Data in Cancer Clinical Trials: Guidance for Industry. Technical Specifications Document. CDER November 2023.
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.