Why Clinical Trial Support is Important!
February 13, 2018
By Neozene

Clinical trials are a key research tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don’t know:

• whether a new approach works well in people and is safe and
• which treatments or strategies work best for certain illnesses or groups of people.

Some clinical trials show a positive result. For example, the National Heart, Lung, and Blood Institute (NHLBI) sponsored a trial of two different combinations of asthma treatments. The trial found that one of the combinations worked much better than the other for moderate persistent asthma. The results provided important treatment information for doctors and patients.

The results from other clinical trials show what doesn’t work or may cause harm. For example, the NHLBI Women’s Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT was already in common use for the treatment of menopausal symptoms. It also was increasingly being used for prevention of heart disease.)

The study found that HT increased the risk of heart disease in the first few years, and HT also increased the risk of stroke and blood clots. In women who took a combination of estrogen and progestin, the risk of breast cancer also increased.

As a result, the U.S. Food and Drug Administration now recommends never using HT to prevent heart disease. When HT is used for menopausal symptoms, it should be taken only at the smallest dose and for the shortest time possible.

Neozene teams have worked at all levels of project development and with myriad challenges and development concerns. Let our knowledge and experience work for you to more efficiently develop your protocol or development program, with the following clinical trial support services:

• Budgets and Contracts
• Grants and Investigator Payments Management
• Regulatory
• Protocol Development
• CRF Development

Whether your new product is a drug, a biologic, a device or a combination, our experience is ready to work with you to set and deliver on aggressive timelines that control costs. Neozene’s clinical trial support services benefit your project during all phases of development, whether it is preparing the IND or IDE to facilitate the first studies in humans or preparing an application (Marketing Authorization Application (MAA), New Drug Application (NDA), Pre-Market Approval (PMA) or 510k) for review by regulatory authorities.