White Papers

  1. Returning Study Results To Research Participants

    Studies show that most clinical trial participants want to know what was learned from their involvement. A growing number of sponsors are implementing plans to deliver plain language summaries to trial participants.  Read this white paper to learn about the current best practices for the content and preparation of plain language summaries, and the current guidance for how sponsors should work with Institutional Review Boards (IRBs) which have oversight of the clinical trials for which the summaries are provided.

  2. Virtual Clinical Trials Best Practices

    In recent years, alongside the increase in patient involvement in the design and conduct of research programs, there has been a notable increase in the idea of “virtual” or “decentralized” clinical trials.  This paper examines the nature of virtual clinical trials, potential benefits and risks of this new paradigm, and best practices for maintaining regulatory and Institutional Review Board (IRB) compliance.

  3. Clinical Trial Recruitment Practices: The Evolution Of Ethical Considerations

    Recruitment practices for clinical trials have evolved significantly over the last few decades. Read this white paper to learn about the evolution of acceptable recruitment practices, and what IRB members typically look for when reviewing recruitment materials and practices.

  4. Rare Disease: Operationalizing Gene Therapy Trials

    Even measured against the vast scientific mystery that defines the biotech industry, gene therapy poses extraordinary challenges. This paper explores the history of gene therapy trials, as well as the types of gene therapy vectors and delivery strategies. Also discussed is the regulatory and operational challenges associated with gene therapy trials, including start-up regulations, site selection, recruitment, and retention.

  5. Summary, Critical Details, And FAQ For Your TMF Management

    The EMA’s final “Guideline on the content, management, and archiving of the clinical Trial Master File (paper and/or electronic)” provides stakeholders with guidance on TMF creation, management, and archival. This overview summarizes and interprets the EMA’s “Guideline on the content, management, and archiving of the clinical Trial Master File (paper and/or electronic).”

  6. Registry And Natural History Studies: Vital, Contrasting Roles In Rare Disease Clinical Research

    Both registry studies and natural history studies play important roles in rare disease research. Understanding the differences between the two types of studies and how they can be used to inform clinical development can help sponsors plan for success.

  7. Finding New Solutions To A Current Unsustainable Model Of Clinical Trial Contracts & Budgets

    In a clinical trial, so much depends on contract execution and budget development; when they are not appropriately managed, progress across other study start up areas comes to a halt. Valuable time is waster, which costs dearly. By implementing three successful approaches to a new way of conducting contracting and budgeting, sponsors and CROs can see a 37% faster site contract execution timeline.

  8. Pediatric Clinical Research: Legislation Has Brought Progress, But More Is Needed

    Overall, the progress made to date in pediatric clinical research is encouraging. However there is still room for progress to be made to enable more approved drugs to be brought to market that will help to control diseases in children, as well as offer potential cures. With collaboration of regulators and stakeholders on the rise they are also working to make more pediatric medicines available to children who need them.

  9. Minimizing The Burden Of Clinical Trials On Children To Accelerate Pediatric Drug Development

    One of the major challenges in conducting clinical trials in children, especially in rare and orphan diseases, is the limited availability of patients and reluctance of many parents and caregivers to enroll their child in a trial with an experimental therapy. Read more about the FDA and EMA concept of pediatric extrapolation to minimize the number of children that need to participate in a clinical trial.

  10. Pharmacometrics: How PK/PD Modeling And Simulation Are Helping To Advance Pediatric Trials

    Pediatric PK/PD modeling and simulation techniques are cornerstones of pediatric drug development. Read how PK/PD and other approaches to pharmacometrics address challenges of limited availability of suitable patients and parents’ inherent reluctance to expose children to unknowns.