AIDS TREATMENT NEWS No. 066 - October 7, 1988
John S. James

* Is the goal to do monitoring studies, prospective trials, or both?

Monitoring studies -- for example, collecting records from physicians offices of patients who have used a particular treat- ment -- are much easier and less expensive. In New York, volunteers have done much of the legwork. Such studies can show trends; but the research community considers them only suggestive that further research should be done, if a treatment looks good.

Prospective trials, which are more definitive, ask patients to follow protocols designed in advance by research profession- als, instead of simply recording what the patients are doing anyway.

The New York CRI has both kinds of trials under way.

* There is a major shortage of principal investigators to design and manage AIDS treatment trials. NIH and pharmaceutical companies have a big problem finding qualified people, the CRI has had major problems, and for a new organization it could be even more difficult.

The principal investigator (PI) does not need to be an M. D.; many are Ph.D., although the combination of both degrees is strongest for getting published. The PI does need to know about AIDS, know how to design clinical trials, and have the time; it often takes about 20 hours a week to manage a study: write the protocol, get it approved by committees, negotiate among all the parties, recruit subjects, manage the data collection, analysis, writing and publication, etc.

Often the PI trusts someone with less training, such as a research nurse, to draft the protocol and change it as required, make phone calls when possible, etc. The PI must sign off on the result, of course. Perhaps the ten to 20 hours a week could be reduced to two or three this way, making it much easier for top people to serve as the PI.

* Pharmaceutical companies are very unhappy with the NIH clinical research system, because it is too slow and for other reasons, so they are looking for alternative ways to test their drugs. The New York CRI has had a number of requests from both large and small companies to run trials for them. If a community-based research organization is credible, and is an attractive site for testing pharmaceutical-industry drugs, it will probably be able to do this work. On the down side, such organizations might be seen as a bread-and-butter threat by other researchers, making it harder to get the effort off the ground.

* Promoters with money have also approached the New York CRI, trying to get favorable publicity for dubious products. Any research organization must be careful.

* New York had much difficulty getting funding to study non-commercial treatment options (like most of those listed below). Therefore it had to focus on what pharmaceutical companies wanted to test. CRI had to live for a long time on its $5,000 seed money from the PWA Coalition. But now it should be possible to raise money much more quickly, because the community-research concept has become well known and established.

* If such funding is available, an organization could build a reputation for doing quality research on grassroots treatments. Clearly this work should be done -- we need to study what people are in fact using -- but because of lack of funding, this research is now largely neglected.

* A typical community-based prospective study with 10-20 people lasting several months might cost $30,000 to $70,000. Much of the expense is for laboratory testing. Also, someone needs to be hired for "keeping the books" on the data. There is also the cost of physician examinations. And of course there is overhead -- rent, staff, telephone, etc. for the organization.

* What about minimizing expenses by building the study around laboratory tests which patients will be doing anyway? CRI considered this approach. Two potential difficulties are (1) community objection that only those insured or who can pay for their care could participate, and (2) concern that insurance companies should not be billed for research (against which others say that if the blood tests are going to be done anyway for treatment, there is no ethical imperative to waste the data). These issues were discussed in the CRI, but not resolved.

It may be possible to conduct scientifically sound, credible research ultra-cheap -- by carefully designing studies which organize elements of patient care which already exist and are paid for. But if funding is available, it should be used to assure faster results by following more conventional, better tested procedures.

* The CRI obtained space for a clinic -- to facilitate administering aerosol pentamidine, drawing blood to be sent to the same lab, and data collection. Physical examinations, however, are still done at the offices of individual physicians, who then send a form to the CRI.

* Community-research organizations need to involve many pro- fessional people besides physicians in support of their effort -- for example, fundraisers, statisticians, and attorneys. The clergy can be helpful in making connections. Many people in the business community would be ready to help but have not yet been asked.

* In New York, the CRI has developed many procedures and documents that others can use. For example, its IRB (institutional review board) recently approved a set of documents providing a flow sheet of what the IRB must do for a trial. New efforts for community-based research can benefit from the experience of the CRI, and of other organizations that want to help.

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