• A new study quantifies and confirms the long-held belief that clinical investigators become top study drug prescribers following both pre- and post-approval studies. Interestingly, CRO involvement dampens this effect. The new study may stoke the fire of regulatory reform by raising additional concerns about investigator disclosure and informed consent.

Article 254: Improving Minority Inclusion

• Responding to growing sponsor needs for broader minority inclusion, associations and investigative sites are taking action. This year, the FDA plans to provide additional guidance for sponsors to ensure demographic subgroup representation in New Drug Applications.

• Over the past several years, the climate for conducting clinical research in Europe has evolved. In some countries, advertising for patients has become more acceptable. As part of this trend, several initiatives have focused on creating a more accessible milieu for clinical trials information. In fall 2000, CenterWatch looked at one such initiative, the metaRegister, a project designed to facilitate a global clinical trials registry. Since then, difficult market conditions have caused the organization to change its business model and delay this initiative.

• Asthma afflicts nearly 17 million Americans, and 45 million Americans suffer from allergies. These diseases can range from being a daily annoyance to causing disability or death. New medications in the pipeline are targeting the body's immune and neuroregulatory systems to alleviate symptoms of asthma and allergies.