Enhancing the diversity of clinical trial populations is critical to achieving equity in healthcare and improving health outcomes in our most vulnerable populations.  Historically, clinical trial populations have been rather homogenous, and treatment effect and patient outcomes observed in a trial setting may have limited applicability to the larger ‘real world’ population.

This Award will recognize a company, team or individual who has demonstrated exceptional initiative in promoting diversity and inclusion of underrepresented populations within a clinical trial or drug development program. The entrant should describe the activities/strategies implemented and the impact they had on patient enrolment. Activities ranging from patient-focused study design, use of technology, awareness and recruitment campaigns, or other creative and innovative approaches will be considered.  Evidence of the impact these activities/strategies had on recruitment should also be included.

WHAT YOU NEED TO KNOW

To enter this category, please answer the following:

• Full details of the project; i.e. project name (i.e. name of drug candidate or trial title), phase of development, target indication and population studied (if applicable), sponsor(s), and the primary drug(s) tested.
• What specific strategies/activities were undertaken? At what point in the study were they deployed?
• Describe the impact the strategies/activities had on study recruitment.  Please share any relevant metrics used for measuring impact.
• If available, please provide documentation (URL) of trial recruitment campaign or any other publicly available sources that illustrate the strategies/activities undertaken.
• The qualifying period for submissions is August 2021 – January 2023

This Award will recognize an early phase research project that met or surpassed its objectives on a range of key performance indicators. The entrant should show that the successful completion of the program was material in enabling the sponsor to advance its drug to the next development phase either on or ahead of schedule and/or keeping within its development budget.

WHAT YOU NEED TO KNOW

To enter this category, please provide the following:

• Full details of the project; i.e. project name (i.e. name of drug candidate or trial title), phase of development, target indication and population studied (if applicable), sponsor(s), and the primary drug(s) tested.
• Summarize the major findings of the study, such as in vitro/in vivo results or primary/co-primary and main secondary endpoints.
• What were the main milestones and deadlines for the preclinical or Phase I study? Please supply evidence of how these were met or surpassed.
• How did this study enable advancement of the drug to the next development stage?
• If available, please provide documentation (URL) of trial results; i.e. press release, investor presentation, conference abstract/presentation, clinical study report synopsis or other publication.
• The qualifying period for submissions is August 2021 – January 2023

This Award will recognize the clinical research team who have made significant contributions in advancing a new therapy through one or more clinical phases.  The judges will be looking to reward the high performing team that has been most successful in reaching its goals, adopted effective working practices, achieved major milestones within expected timelines, and contributed to the advancement of new therapies.

WHAT YOU NEED TO KNOW

To enter this category, please answer the following:

• The company’s name, the team being entered and basic details of its core project.
• What was the greatest achievement of the team during the qualifying period?
• How did all members/functions of the team work together to achieve its goals?
• How does the achievement contribute to advancing new therapies to market?
• What work practices has the team adopted to support the success of the product’s development?
• If you believe that this team is particularly outstanding, but for reasons not covered in the questions above, please give relevant details.
• The qualifying period for submissions is August 2021 – January 2023

This Award will recognize the clinical trial which reported results that had the greatest impact and is expected to lead to an advance in healthcare. The judges will be looking to reward the clinical trial with the largest commercial impact, highest impact on patient population, the greatest disruption in a market, or the advancement of clinical trial design. This might include the first demonstration of a clear clinical effect for a new drug in an area of unmet medical need, a pivotal study of a new drug with a breakthrough mechanism of action, or a major study of a potential new or expanded indication for an already marketed product.

WHAT YOU NEED TO KNOW

To enter this category, please provide the following:

• Full details of the study; i.e. trial name (title, protocol ID, trial identifier), phase, disease type and patient segment(s) studied, sponsor(s), and the primary drug(s) tested.
• Summarize the major findings of the study, including all primary/co-primary and main secondary endpoints, and safety endpoints.
• Provide evidence supporting uniqueness and advancement of knowledge in an area of unmet medical need or clinical trial design.
• How do these findings represent a potential leap forward in therapy?
• Documentation (URL) of publicly available trial results required; i.e. press release, conference abstract/presentation, clinical study report synopsis or other publication.
• The qualifying period for submissions is August 2021 – January 2023

The attempt to combat rare diseases is a challenging task that exemplifies how the pharmaceutical industry addresses unmet medical needs. This Award will recognize the efforts of an individual, team, or company that demonstrated excellence while developing a drug intended to treat rare diseases. The judges will be looking for a drug development program or trial with the largest potential impact in the rare disease space. Outstanding patient centric processes and innovation in study conduct to overcome the various obstacles of rare disease drug development will also be rewarded.

WHAT YOU NEED TO KNOW

To enter this category, please provide the following:

• The name of the individual, team or company, including an outline of their role(s).
• Details of the drug development program or clinical trial; i.e. rare disease(s) being targeted, name of drug(s), trial name(s) (title, protocol ID, trial identifier), phase, patient segment(s) studied, and sponsor(s).
• Provide evidence of the impact that the drug has had, or potentially could have, on the patient population and addressing unmet medical needs.
• Describe any unique strategies used to ensure successful clinical research conduct within this challenging space, such as trial design, patient centric processes (i.e. close engagement of patient advocacy groups), innovative patient recruitment methods in identifying potential trial participants, or study planning strategies (i.e. use of surrogate markers or original tools and approaches to gather key clinical data).
• If available, please provide documentation (URL) in support of the achievements described.
• The qualifying period for submissions is August 2021 – January 2023

This Award recognizes the promising and disruptive role that digital health technology is currently playing in clinical trials.  Technological innovators are discovering novel ways to gather high quality patient data using an array of digital tools.   Advances in development of smartphone apps, mobile health devices, and a host of other products are revolutionizing the way patients participate in clinical trials. The judges will be looking for the product that represents the best advance in improving patient data collection and/or the patient experience in clinical trials. Those considered may include electronic patient diaries, mobile health devices or any other digital tools that support, encourage or aid the patient’s participation in the clinical trial.

WHAT YOU NEED TO KNOW

To enter this category, please provide the following:

• The name of all companies involved in the product development, including an outline of their role(s).
• Specify the date and market of the technology’s first launch, if applicable.
• Outline the key features and benefits of the technology, and how they support the patient’s clinical trial journey.
• What problems does this product solve and what is novel about it?
• What is the single most significant benefit of the entrant’s technology to users?
• If possible, please provide a link to a product demo (product webpage, YouTube video, etc.).
• The qualifying period for submissions is August 2021 – January 2023

This Award recognizes the vital importance of using the most sophisticated platforms to catalyse and optimize data gathered during clinical trials. Advances in software and applications have a pivotal role to play at all stages of the trial process, assisting Sponsors in effective management of study logistics, monitoring, risk mitigation and timely data collection and analysis.  The judges will be looking for the product or suite of products that help study teams better manage and oversee clinical trial activities.

WHAT YOU NEED TO KNOW

To enter this category, please provide the following:

• The name of all companies involved in the product development, including an outline of their role(s).
• Specify the date and market of the technology’s first launch, if applicable.
• Outline the key features and benefits of the technology, and how they support the clinical trial process.  Where benefits include cost or time savings, please provide supportive data.
• What problems does this product solve and what is novel about it?
• What is the single most significant benefit of the entrant’s technology to users?
• If possible, please provide a link to a product demo (product webpage, YouTube video, etc.).
• The qualifying period for submissions is August 2021 – January 2023

This Award will be presented to two or more organizations who have set a new benchmark in partnering through collaborative clinical trial activity that took place in 2021/22.  Partnerships could take place between multiple pharmaceutical and/or biotech companies or between a pharmaceutical and/or biotech company and a contract research organization, research institute, non-profit, or cooperative group.

WHAT YOU NEED TO KNOW

To enter this category, please provide the following:

• Provide the names of organizations involved and basic details of the partnership.
• Why was the partnership novel?
• How does this partnership set a new benchmark for other deals?
• How has partnership achieved an outcome that would not have been possible if partnership had not been created?
• If available, please provide documentation (URL) in support of the achievements described.
• The qualifying period for submissions is August 2021 – January 2023

Artificial intelligence (AI) is revolutionizing healthcare and its application in Pharma is gaining momentum.  AI technology provides new opportunities to improve drug discovery, clinical development and commercial adoption of new medicines.  This Award will recognize the efforts of an individual, team, or company in leveraging artificial intelligence to improve a clinical trial process, or to support the successful execution of a clinical trial.

The judges will be looking for innovative uses of AI that provide a meaningful impact on protocol design, trial execution, or other related activities.

WHAT YOU NEED TO KNOW

To enter this category, please answer the following:

• The name of the individual, team or company, including an outline of their role(s).
• Details of the clinical trial or drug development program; i.e. disease(s) being targeted, name of drug(s), trial name(s) (title, protocol ID, trial identifier), phase, patient segment(s) studied, and sponsor(s).
• Describe the utilization of artificial intelligence in the context of the trial/drug development program; if machine learning (ML) is involved, be sure to describe how ML is used.  AI/ML to support any stage of the clinical trial journey may be submitted, including but not limited to:
  
  1. Protocol development, including identification/refinement of study population and entry criteria, study design, endpoint selection
  2. Patient recruitment or retention
  3. Trial monitoring practices, including safety monitoring
  4. Clinical data management
• Evidence of the impact the use of artificial intelligence had (or is having) on the trial/drug development program.  Describe how the use of AI has improved the trial(s) or trial process.  Provide relevant details on how AI has helped reduce costs, improve quality and/or save time.  If available, please provide documentation (URL) in support of the achievements described.
• The qualifying period for submissions is August 2021 – January 2023

Clinical trials are high risk, expensive, resource-intense undertakings that present significant challenges to small companies with limited financial and human capital.   This award will recognize a start-up pharma/biotech company that has developed creative and innovative approaches to the formidable challenges that clinical trials present to small organizations.  Solutions may include innovations in designing team structures, resourcing solutions, technology, or process/workflow efficiencies around any clinical trial related activity.  Solutions must be those developed or applied between August 2021 – January 2023.

WHAT YOU NEED TO KNOW

To enter this category, please provide the following:

• The name of the company and the innovative solution
• Specify the date of first implementation
• Outline the key features and benefits of the innovation, and the impact it had on the study timeline, costs or quality.  Where applicable, include cost and/or time savings data to support any claims.
• What problems does this innovative approach solve and what is novel about it?
• If possible, please provide additional supporting documentation (process flow chart, Vimeo/YouTube video, etc.).
• The qualifying period for submissions is August 2021 – January 2023

Sponsors and drug development teams are increasingly adopting novel recruitment strategies and technologies to actively engage patients in the clinical trial journey. To support successful enrolment and to better understand the perspective of the patient, fundamentals of consumer and behavioural science are being applied in the clinical research arena. This Award will recognize the efforts of an individual, team, or company in bringing innovative approaches to support patient-consumer engagement in clinical trial recruitment. The judges will be looking for creative initiatives that fostered connection with the patient community and delivered a positive and meaningful impact on trial enrolment.

WHAT YOU NEED TO KNOW

To enter this category, please provide the following:

• The name of the individual, team, or company, including an outline of their role(s).
• Details of the clinical trial or drug development program, i.e., disease(s) being targeted, name of drug(s), trial name(s) (title, protocol ID, trial identifier), phase, patient segment(s) studied, and sponsor(s).
• Describe the initiatives undertaken to support patient recruitment and engagement for the trial/drug development program. Activities to support any phase of the clinical trial journey may be submitted, including but not limited to:
  1. -Protocol development, including elements of inclusion/exclusion, study design, endpoint collection
  2. -Patient centric recruitment activities and campaigns
  3. -Caregiver engagement
  4. -Initiatives to enhance patient convenience and encourage enrolment
• Evidence of the impact the activity had on the trial’s recruitment/retention; if available, please provide documentation (URL) in support of the achievements described.
• The qualifying period for submissions is August 2021 – January 2023

Fuelled by the digital revolution in healthcare data, clinical research teams are increasingly advancing drug development through use of real-world data (RWD) and real-world evidence (RWE). Both can have many tactical applications throughout the clinical development lifecycle. From study design to site selection and patient recruitment, to safety monitoring and post-market surveillance, RWD represents an efficient and powerful tool to drive insights and optimize clinical research. And RWE, when fit for purpose, can play a pivotal role in drug approvals, as acknowledged in recent regulatory guidance documents.

This Award will recognize the efforts of an individual, team, or company that demonstrates excellence in applying RWD/RWE to support drug development. The use of RWD/RWE could occur as early as development of the protocol concept, through trial completion and/or regulatory application submission. The judges will be looking for creative and innovative uses of RWD/RWE to support a drug’s clinical development journey.

WHAT YOU NEED TO KNOW

To enter this category, please provide the following:

• The name of the individual, team, or company, including an outline of their role(s).
• Details of the use case - disease(s) being targeted, name of drug(s), trial name(s) (title, protocol ID, trial identifier), phase (if applicable), patient population studied, and sponsor(s).
• Describe the key objective that the RWD/RWE supported – what and how it was done
• If available, please provide documentation (URL) in support of the achievements described
• The qualifying period for submissions is August 2021 – January 2023