September 18, 2019
Optimizing outcomes faster - together
We kicked off a new season of PMCQ meetings with a panel of speakers showing us how one non-profit is helping to drive the efficient delivery of innovative new medicines with solutions that benefit patients, researchers, health care providers, payers, and the pharmaceutical industry alike. This event left us with clear insight into the pioneering mission, strategy and operations of TransCelerate BioPharma.
Opening Remarks and Housekeeping Julie Arel, PMCQ President
- Welcome back! The mission of the PMCQ is to facilitate lifelong learning, career development, and networking, and we’ve got an exciting year of events for 2019–2020!
- The event calendar is here and there are both morning and evening meetings — something for everyone!
- The October event is Transformation: What it means and how to implement it and it will present new ways to innovate in highly regulated industries, such as ours.
- Thank you to all of our partners for making these meetings possible.
- Thank you to Ogilvy Health for doing the creative for this event and Merck for their sponsorship of the event.
- One of the many perks of attending PMCQ events is the door prizes! At this meeting, we gave away one course taught by the Council for Continuing Medical Education. If you would like a chance to win a neat prize such as this, join us for October’s meeting!
Itroduction of speakers Zeshan Farooqui, Rana Salame PMCQ Directors
The meeting featured a panel of speakers:
- Dr. Saliha Boumaza (Chair): Country Co-Lead - Canada for TransCelerate BioPharma and Executive Director, Clinical Research at Merck Canada
- Nathalie Dutil: Senior Manager, Site management at Bristol Myers Squibb
- Nathalie Dagenais : Site Engagement Manager at Eli Lilly Canada
- Mona Maroun – Director, Clinical Site Management at Pfizer
Overview of TransCelerate BioPharma Saliha Boumaza
- TransCelerate BioPharma 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, improving the health of people around the world.
- It is a global organization currently working with 22 countries and 13 health authorities.
- There are 20 member companies: AbbVie, Allergan, Amgen, Astellas, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Merck KGaA, GlaxoSmithKline, Johnson & Johnson, Lilly, Merck & Co., Novartis, Novo Nordisk, Pfizer, Regeneron, Roche, Sanofi, Shionogi, and UCB.
- TransCelerate BioPharma provides solutions that are available publicly on their website — you do not need to be a member!
- There are currently more than 25 solutions to support clinical trials globally.
- Among them, 4 started recently and are related to pharmacovigilance studies.
- Over 1,000 people are working together to design the solutions; this includes external stakeholders (site investigators, research and CRO committees, patient organizations, and health authorities) who provide valuable feedback on the solutions and provide ideas for other needed initiatives.
- Check out this video for more information.
- Two points of focus for the organization that were discussed at this meeting are: 1) increasing clinical research awareness, and 2) improving patient and site experience.
- Currently, health care providers don’t present clinical trials to patients as a treatment option, and clinical trial information is very hard to find.
- There is a large administrative burden to run a clinical trial (e.g., sponsors are always asking research sites the same questions over and over); TransCelerate BioPharma helps to relieve this burden by standardizing processes and removing redundancies.
Shared Investigator Platform (SIP) and the “One Person Closer” campaign Nathalie Dutil
- The SIP is one solution that removes redundancies and alleviates administrative burden in the processes involved in implementing and running a clinical trial.
- It is a platform that creates connections and streamlines interactions between the sponsors and the research sites.
- Each sponsor has their own portal on which the sites can access documents related to the clinical trials, such as protocols and training materials.
- All portals have the same format and functionality, so they are easy to use.
- Example of how the SIP is useful in the site selection process:
- The first step is to access the registry of investigators, which is a repository of information about sites that includes research history and performance metrics, such as recruitment success.
- From this registry, sponsors can do a preselection of sites they are considering for trials.
- Then, this list of preselected sites is used to generate a feasibility questionnaire in order to ask more specific questions. Once the questionnaire is completed, the sponsor is notified and can review the results to make a decision.
- Everything is done electronically.
- The SIP has been shown to reduce the process completion time from several weeks down to an average of 8 days and reduce the number of survey questions by 50%.
- The “One Person Closer” campaign was another initiative by TransCelerate BioPharma with the goal to increase clinical trial awareness:
- Only 14% of patients find out about clinical trials from their HCPs, so the campaign was launched to inspire HCPs to believe in the value of clinical trials and share more information with patients; it used social media and had videos of people sharing their personal stories.
- Clinical trial awareness:
- Informs and empowers patients
- Helps HCPs support their patients with more treatment options
- Helps researchers to increase enrollment, which leads to faster clinical trial results and faster access to medicines
- Lowers health care costs for payers because safer and more effective drugs can enter the market sooner
- Allows better representation of the Canadian patient population, providing more useful information for regulators to review
Increasing clinical research awareness Saliha Boumaza
- One statistic shows that 3 out of 4 patients suffering from cancer do not get the opportunity to participate in a clinical trial, which could be offered as a last resort.
- TransCelerate BioPharma wants communication between HCPs and patients to include trial participation as one of the treatment options; work is being done to understand the physician needs in order to facilitate this conversation.
- Patient groups have identified another gap: it is difficult for patients to find information online.
- Patient groups want to have a website with a registry that is easy to navigate and not too technical; TransCelerate BioPharma won’t create a registry but is working with governments to create registries like clinicaltrials.gov (with proposals to improve the user experience).
Solutions to improve the patient user experience Nathalie Dagenais
- E-consent assets are a multimedia component to help the consent process, changing it from a 20-page paper document to a web-based experience that is accessible by iPad, phone or computer.
- The consent no longer needs to be signed at the trial site, allowing patients to review it with other family members.
- Patients can electronically flag the parts of the consent that are not clear and can view videos; there are also hyperlinks to more details about what certain words mean.
- This solution tracks how much time patients spend reading the consent form and there is a knowledge check throughout to ensure they truly understand the consent process.
- The patient protocol engagement toolkit is a solution that includes input into the design and implementation of trials (e.g., ensuring that patients do not need to undergo too many assessments, etc.) and collects feedback around communications about the trials.
- Including this step minimizes amendments for the sponsor and improves retention rates to deliver drugs more quickly to market.
- The patient information exchange templates survey the patient experience from the moment patients are enrolled to completion of the trial.
- All tools start with a “thank you” and include around 6 to 12 questions.
- These are available on the website and can be customized.
All of the solutions and tools presented at the meeting are available to the public on the TransCelerate BioPharma website. Check out their videos and sign up for the newsletters!
Freelance Medical Writer