Evaluate your institution’s clinical trial portfolio and participant population

Confirm that the trial’s scientific question is relevant and of interest to your institution

  • Talk with your colleagues and institutional leadership to gauge their interest. Think about whether the trial is important and salient to your organization’s goals and the needs of its patient population.

Assess where the trial fits within your institution’s portfolio of open trials

  • Look at your organization’s research as a whole- both basic scientific as well as clinical research. 
  • Evaluate whether the trial furthers your work in a relevant area.
  • Also, look at all your institution’s open trials and evaluate whether the proposed trial fills a gap or helps you offer patients a fuller spectrum of trials.
  • Importantly, check for competing trials.

Verify that there are no conflicts of interest in this trial

  • Find out about any conflicts of interest early.

Ensure that the trial matches your patient population

  • Review your databases and what you know about your community.
  • Determine whether your institution sees enough potentially eligible patients or can identify and reach sufficient numbers to meet recruiting goals in a timely way.
  • Ask if your institution has succeeded in recruiting to similar studies in the past.

Assess the financial burden the trial will place on participants

  • Explore what expenses will be covered by the trial sponsor, private insurance or Medicare, and what the out-of-pocket costs will be to participants.
  • Keep in mind that not all costs are medical (e.g., travel expenses and meals).

Determine the level of study burden on participants and their support systems

  • Ask your staff whether they think the burdens (e.g., blood draws, overnight stays, or unpleasant medical procedures) are within reason for your population.

Literature and Tools (72)

Image Representing Resource Type (Journal Article)
Ethical and Scientific Implications of the Globalization of Clinical Research.
Posted: Feb 13, 2013.
Glickman SW,McHutchison JG,Peterson ED,Cairns CB,Harrington RA,Califf RM,Schulman KA. N Engl J Med. 2009 Feb 19. 360. 8. 816-23.
KEYWORDS: Remuneration, Level of Clinical Trials Knowledge or Awareness, Incentives, Staff Experience Level, International, Institutional Issues, Regulatory Issues, Financial Incentives, Cancer
Image Representing Resource Type (Journal Article)
Effect of patient socioeconomic status on access to early-phase cancer trials.
Posted: Jan 17, 2013.
Mohd Noor A,Sarker D,Vizor S ,McLennan B,Hunter S,Suder A,Moller H,Spicer JF,Papa S. J Clin Oncol. 2013 Jan 10. 31. 2. 224-30.
KEYWORDS: Underserved, International, Eligibility, Older Adults, Minority Groups, Cancer, Phase 0,1,2
Image Representing Resource Type (Journal Article)
Establishing a Minority-Based Community Clinical Oncology Program: The University of Medicine and Dentistry of New Jersey, New Jersey Medical School–University Hospital Cancer Center Experience.
Posted: Nov 28, 2012.
Wieder R,Teal R,Saunders T,Weiner BJ. J Oncology Practice. 2012 Nov 27. [Epub ahead of print]
KEYWORDS: Level of Clinical Trials Knowledge or Awareness, Incentives, Physician Champions, Institutional Issues, Minority Groups, Cancer
Image Representing Resource Type (Journal Article)
Addressing challenges in cancer trials accrual: a look in the mirror.
Posted: Nov 01, 2012.
Michaels M. Appl Clin Trials Online. 2012 Oct 05. 6 pages.
KEYWORDS: Logistics/Transportation, Level of Clinical Trials Knowledge or Awareness, Staff Experience Level, Provider-Patient Relationship, Institutional Issues, Eligibility, Cancer
Image Representing Resource Type (Journal Article)
Barriers to therapeutic clinical trials enrollment: Differences between African-American and White cancer patients identified at the time of eligibility assessment.
Posted: Oct 04, 2012.
Penberthy L,Brown R,Wilson-Genderson M,Dahman B,Ginder G,Siminoff LA. Clin Trials. 2012 Oct 02. [Epub ahead of print]
KEYWORDS: Knowledge/Attitudes/Beliefs, Logistics/Transportation, Cost/Insurance, Remuneration, Attitudes, Insurance Coverage, Eligibility, Randomization, Study Burden, Minority Groups, Black or African-American, White or Caucasian, Cancer

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