A Site Team’s Perspective on Clinical Trials; a Look at the Industry with Amanda Wright

Posted by Paddy Wall on Mar 19, 2019 9:17:02 AM

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This is an excerpt from Longboat's downloadable interview series "Expert Opinions: How the Clinical Trial Industry Needs to Evolve?" featuring full interviews with high-impact leaders from the clinical research world. To access the full interview series, click here.



Meet the Interviewee: Amanda Wright, Executive Director at Greater Gift.

AWright_GreaterGift_18April2018_FinalAmanda Wright is the Executive Director of Greater Gift, a non-profit that was founded in 2010 for the purpose of celebrating and expressing gratitude to clinical trial participants and contributors. In addition, Amanda dedicated nearly twenty years to PMG Research – one of the largest site organizations in the world, where she served as an executive leader managing teams responsible for business development, feasibility, patient engagement, and corporate communication.



As someone who managed multiple sites and hundreds of trials, what were the major challenges that you've faced over the years?

When leading a network that represents a diverse population across different communities, you must be flexible yet maintain a high level of standardization.  Operating a highly standardized and high-quality platform requires continual process improvement effort. At the same time, you must balance this with creating a customized, flexible experience for physicians and healthcare partners as they work differently, and patient needs can be different, whether that be driven by their condition or by region.


What is your secret to managing that balance successfully?

First and foremost, it is recognizing the different personalities, tendencies and motivations as you continually work to bring together highly effective teams. As you are making decisions, you must constantly assess the characteristics of that situation, that study, the PI, the study coordinator, the resources supporting the study, and position all of these to be successful as a group. While there should be standards, each trial has its own personality and challenges that must be recognized to achieve success.  It is a team sport.


What works well for engaging investigators, and what doesn’t work so well?

You first must understand who you are working with and then structure an environment and workflow that is well suited to the situation.  Effectively engaging an investigator is highly dependent upon how well you integrate clinical research activities and support into their existing workflow. Surrounding investigators with the right resources, tools – a research team – and taking into account preferred means of communication and use of technologies will best serve the investigators and the patients for whom they care.  While I think we have a responsibility to continually innovate and integrate progressive tools and resources – at the same time, there is a point of balance. It is a matter of who you are engaging and how you are engaging them, understanding their orientation and ensuring that you are building an effective workflow that ultimately serves the patient.

Read our full interview series featuring some of the most high-impact business  leaders in clinical research.

What’s behind the ‘one and done’ issue and how would you address it?

As I see it, two common issues are trial complexity and the lack of adequate clinical research staff to support effective execution. Conducting clinical trials in a highly efficient and effective manner requires scale, technology support tools and qualified staff and time. Many investigators or sites that are ‘one and done’ are likely driven by the choice that was made regarding the first project(s). Many times, physician investigators take on a trial that may not have been the right trial for their first clinical study or the right trial for their site, period. The answer is adequate training, engagement of qualified clinical research personnel and leveraging data to ensure predictive trial performance and execution.


What can be done to help investigators sign up to a trial that is right for them?

Unfortunately, what often happens is investigators are presented limited trial information and in conjunction with any limited experience and perspective, decisions to engage and projections around performance can be guided by instinct rather than data.  My recommendation to any physician who is considering clinical research is find a resource that can help guide you through the clinical trial process.  In addition to trained staff, there are resources that work on a contractual basis with physicians or research sites to support clinical research needs. When determining the right trial, several factors must be assessed and aligned: access to patients based upon the protocol, the physician investigator perspective, and the clinical research staff perspective. Collectively, it is possible to make sound decisions regarding the right or not so right trial for a physician and site.


What would be your advice to someone managing multiple sites based on what you've learned over the years?

Ensuring established workflow and incorporation of technology are key. I am a dreamer and believer that we will reach the point in time where clinical trials are widely executed in a paperless environment. We are starting to see the emergence of the core technologies for this to be possible, but we are not there yet. Tremendous inefficiency continues to exist given the lack of integration across such tools.    Whether managing one site or multiple sites, having a clinical trial management system is absolutely critical to ensure a level of efficiency and transparency that you cannot achieve otherwise. Transparency and efficiency that guides daily, key business decisions.


How did your experience managing sites lead you to the work of Greater Gift?

In collaboration with a number of individuals, we began to assess and advance patient engagement initiatives before we were using the buzz words – patient engagement. As part of focus groups with patients, we recognized their experience in a clinical trial was overall extremely positive. But even though they had a very positive experience, they did not understand or fully appreciate the impact of their participation. They knew it had perhaps improved their health or maybe they had learned something about their disease, but the broader scientific drug development process was not well understood by most. So their participation, while beneficial to them, was lost in terms of their impact on other people and the advancement of medicine. A realization that was and continues to be troubling.  As a team, we were compelled to address such a gap with an emphasis on the integration of philanthropy as part of the initiative.

At the time, there was not a non-profit clinical research advocacy organization within our space. There were patient advocacy organizations very specific to initiatives or diseases or certain therapeutic areas but not to the broader clinical research spectrum. We needed to and wanted to fill this gap.

Ultimately, we wanted to incorporate an immediate positive reinforcement to connect clinical research participation to global health and well-being. We did that by launching a 1+1+1 mechanism where for every clinical trial participant engaged in a clinical trial through one of our partners, a vaccine would be donated in their honour to a child. So, at that moment in time, although we do not know the outcomes of the trial you are participating in, or whether the drug being tested will achieve market status, your willingness as a patient to participate has already made a difference. To date, we have donated over 105,000 vaccines, which means over 105,000 people have been celebrated and over 105,000 children have been vaccinated.  And there is more work to be done.

Read our full interview series featuring some of the most high-impact business  leaders in clinical research.

What have you seen as a result of this celebration of trial participants?

First and foremost, I would say acknowledging clinical trial participants, saying thank you, celebrating their willingness to participate has far-reaching effects. It is important for that individual, but it creates affirmation, satisfaction, and ultimately motivation to share with others about their participation. I’ll give you an example: a situation where a person participated in numerous trials. Once the program was rolled out with this partner, she received her first certificate to indicate a donation had been made in her honour and she was taken aback and very much gratified by the gesture. She ended up telling a family member about the donation. What later came to light was she had never told this family member that she had ever participated in a trial.

This intervention, this expression of appreciation, ultimately led her to talk about the fact that she was participating in a trial. Our goal is to express gratitude but by doing so, we want to serve as a bridge for engagement.   A lot of times in our industry, I think we look for very clear, direct return on investment. The reality is we need to do good by patients and patients will become the best clinical research advocates.


You’ve also been running a competition for sponsors to run events to engage more people with research. How does that work?

PopUp Star started in 2017, and it is an industry-sponsored competition to raise awareness of clinical research at the community level. It is not just aimed at a single community but involves learning across many, diverse communities and understanding when and how people engage in conversations about clinical research along with the impact of such engagement.

We have teams around the world that compete to be crowned the Winner. They come up with their own events to raise awareness in their community and we track the data and the impact to determine which team wins. Ultimately though, everybody is a winner because we are sharing learnings across all those teams that participated in the competition as well as sponsors. You may choose to do a certain type of event in your community, but you get to learn from other teams about the makeup of their events, what they learned, what they would do differently – a multitude of insights with respect to patient engagement and awareness.


Which approaches were particularly effective?

The winner from the first year of the competition partnered with an annual food truck festival in their community. They integrated an education component of clinical research into this food truck festival and within six hours engaged over 500 people in a conversation about clinical research. Another team ran a game show setup centred on learning about clinical research. It is a unique opportunity for the teams to have an opportunity to exercise a lot of creativity and learn from it. We had teams in the United States and Australia, and we are really excited to kick off the competition this year.


What insights about engaging the general public in research have you learned?

When you look across the data and some of the feedback from the teams, it is clear there is a lack of understanding around the concept of clinical research.  Unless we can start a conversation to first raise awareness, define clinical research and why it is needed, then it will be challenging to overcome some of the hurdles we currently face. We need that person-to-person grassroots engagement to help shape the perspective and understanding of clinical research along with improved access to clinical trials.


What difference in the industry do you hope to see in the next decade?

First, we must bring forth the technology solutions that allow us to be a truly progressive, innovative segment of life sciences where we are operating in a completely paperless environment with instant data exchange and continual data surveillance. It will change the way in which we share data, analyze data and how quickly we can do that and get interventions in the hands of patients who are waiting. And this will obviously impact the significant cost associated with drug development, which is critical.

Likely even more important, we must do more as an industry, as a life sciences segment, to educate the broader community and ensure clinical trials are more accessible. I have conversations time and time again with people who do not understand what I do as a professional. I usually ask them a question: “Is there a medication that you take often or every day?”, and then I will walk them through how it is possible, what had to happen in order for you to be able to go to your pharmacy and get that medication every 30 days, 90 days, or as needed. Once you have that conversation, the idea and purpose of clinical research resonates, and people’s perception of it changes. Unfortunately, the general press does not typically report clinical research in a positive light, so we must take more onus in doing so on behalf of our industry. Then I think public engagement in clinical trials will change.


This is an excerpt from Longboat's downloadable interview series "Expert Opinions: How the Clinical Trial Industry Needs to Evolve?" featuring full interviews with high-impact leaders from the clinical research world. To access the full interview series, click here.

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