SENIORS trial

Megraud F, Lamouliatte H. The treatment of refractory Helicobacter pylori infection. Aliment Pharmacol Ther 2003 17 1333-1343. Silverstein FE, Graham DY, Senior IR, et al. Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid arthritis receiving non-steroidal anti-inflammatory drugs a randomized, double-blind, placebo-controlled trial. Ann Intern Med 1995 123 241-249. 

The re-examination of the clinical reports showing that most people who were given reserpine did not become depressed was not published until 1971, a few years after the chemical-imbalance theory had been popularized by Schildkraut and Coppen. But a decade before their influential articles were written, there had been a carefully controlled clinical trial on the effects of reserpine on mood.17 Far from confirming the belief that it made people depressed, the study seemed to show the reverse. Rather than making healthy people depressed, reserpine seemed to make depressed people better. As described by Michael Shepherd, the senior author of the study, in 1956 ... 

Experienced senior staff of the sponsor must always visit the investigator site before a new clinical trial starts, even if the investigator has been involved in previous studies. Most pharmaceutical companies have checklists and SOPs of the requirements of an investigator site. Key questions will need to be answered relating to staff support and the present workload of the site. The competence of the staff to conduct any procedures, the maintenance, calibration and QC of any equipment to be used, and whether other clinical trials demand too much resource are aU questions that need answers. In addition, the facilities should be inspected to establish whether the site could store and securely archive the large amounts of documents and study drugs that will be present. The pharmacy may play a major role in the study and therefore the facility and the pharmacist should be visited. 

To help protect the rights and welfare of volunteers and verify the quality and integrity of data submitted for review, the FDA performs inspections of clinical trial study sites and anyone involved in the research, says David A. Lepay, M.D., Ph.D., senior advisor for clinical science and director of the FDA s Good Clinical Practice Program. Lepay says that the quality of clinical trials has improved markedly since the agency started inspecting them back in 1977. 

An anecdote is useful at this point. During development meetings at a large skin care marketer, we asked how the company would propose to market a product if we had an ingredient that showed remarkable properties in chnical trials. All the 15 or so senior product design chemists in the room wanted to build the ingredient into a cream or a lotion. We mention this not to suggest that creams and lotions are not... 

Energa and Stream Rifle Launched HEAT Grenade. Title is unclassified, but the grenade cannot be described because it is classified Ref Dept of the Army, Senior Standardization Representative, Canada, User Trial Directive,... 

If the trial pool does not meet the specification the Senior Chemist will use his/her judgement to assess a second trial pool. Record the details of further pools on a purification deviation sheet and attach to this process instruction. 

Senior, K. (2002) Dosing in phase II trial of Alzheimer s vaccine suspended,. Lancet Neurol. I, 3. 

The basic principle accepted by biomedical editors is for authors to be responsible for those sections of the work performed by them. It follows that company staff should be authors. Indeed, it is important for readers to know their involvement. However, from time to time some company executives argue that their involvement might be construed as biasing the trial and therefore that they should be excluded. This attitude is either timorous or reveals an element of complicity, or both. The professional role and standing of company staff and their personal development requires better support from senior executives. 

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