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Clinical trial recruitment case study

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Overcoming Recruitment Challenges: Increasing Access To Patients With Impaired Renal Function

Overview

At PharmaNet/i3’s clinical pharmacology unit in Canada, new drugs are evaluated in Phase I clinical studies for the company’s clients. Under the current FDA draft guidance, some studies require the evaluation of drug products in trial participants that have impaired renal (or kidney) function. As part of this effort to ensure patient safety and well-being, a client hired PharmaNet/i3 to conduct a renal impairment study with a compound in development for the treatment of secondary hyperparathyroidism, a complication of chronic renal failure characterized by increased levels of parathyroid hormone (PTH).

The objective of the study was to assess the effect of the compound on an equal number of patients with different stages of impaired renal function. To accomplish this, PharmaNet/i3’s researchers evaluated how patients tolerated a treatment of secondary hyperparathyroidism after a single dose administration. Patients included people with mild, moderate and severe renal impairment that do not require dialysis, as well as a control group of participants whose age and gender match that of normal, healthy volunteers. In particular, researchers studied what patients’ bodies do to the compound (pharmacokinetics) and what the compound does to patients’ bodies (pharmacodynamics).

Challenge

The study’s restrictive protocol made it difficult for the client to recruit volunteers for the trial. Finding patients with both moderate and severe renal impairment, who met the strict inclusion and exclusion criteria of the study, presented researchers with a major challenge to completing enrollment. In addition, certain volunteer requirements, including the need to be hospitalized for approximately 62 hours (or three nights) followed by three consecutive daily outpatient visits during the winter holiday period, proved difficult for study participants, as well as organizers.

Solution

To overcome the recruitment challenge, PharmaNet/i3 introduced a multifaceted approach. The company initiated discussions with nephrology key opinion leaders to review and analyze new data regarding the function and diseases of the kidney. As a result of the discussions, amendments were made to the study’s inclusion and exclusion criteria. These amendments facilitated recruitment and, at the same time, preserved the integrity of the trial.

In addition, through a strategic collaboration with Hôpital Maisonneuve-Rosemont, one of the largest nephrology centers worldwide, PharmaNet/i3 gained access to extensive academic knowledge, nephrology expertise and the sort of patients needed for the study. An in-house clinical diagnostic laboratory, where researchers performed standard safety and specialized tests, eased some of the difficulties associated with volunteer requirements.

PharmaNet/i3 also developed a strategy for working with investigators and the institutional Review Boards (IRBs) to support recruitment efforts. The IRB review process, which included a protocol presentation to the IRB by one of the company’s medical directors, was a key component of this strategy.

Outcome

Demand to conduct pharmacokinetic studies in patients with impaired renal function is increasing. By partnering with nephrology key opinion leaders and a specialized hospital, PharmaNet/i3 helped the client overcome the study’s recruitment challenges and enhanced its access to potential participants with mild, moderate and severe renal impairment. As a result, PharmaNet/i3’s client efficiently conducted trials in patients with various levels of renal impairment, while assuring participants’ safety and well-being.

About PharmaNet/i3

PharmaNet/i3, the inVentiv Health clinical segment, is recognized as a leading provider of global product development services to pharmaceutical, biotechnology, generic drug, and medical device companies, including therapeutically specialized capabilities for Phase I-IV clinical development, bioanalytical services, and staffing from a single clinical professional to an entire functional team. For intelligent solutions needed to accelerate high quality product development programs of all sizes around the world, PharmaNet/i3 works for you. For more information, visit http://www.PharmaNet-i3.com.

About inVentiv Health

inVentiv Health, Inc. is a leading global provider of best-in-class clinical, commercial and consulting services to companies seeking to accelerate performance. inVentiv’s client roster includes more than 550 pharmaceutical, biotech and life sciences companies. With 13,000 employees in 40 countries, inVentiv rapidly transforms promising ideas into commercial reality. inVentiv Health Inc. is privately owned by inVentiv Group Holdings Inc., an organization sponsored by affiliates of Thomas H. Lee Partners, L.P., Liberty Lane Partners and members of the inVentiv management team. For more information, visit http://www.inventivhealth.com.

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